THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rod@welchco.com


S U M M A R Y


DIARY: November 17, 2010 10:18 AM Wednesday; Rod Welch

Cholesterol clinical trial shows promising new drug treatment.

1...Summary/Objective
....Next big thing? Big cholesterol drop with new drug


..............
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CONTACTS 

SUBJECTS
Anacetrapib HDL 150% from 41 to 101 Merck New Cholesterol Drug Treat                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
2003 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
2003 -    ..
2004 - Summary/Objective                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
2005 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
200501 - Follow up                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
200502 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200503 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200504 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200505 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200506 -            [On 160405 1305 Evacetrapib raised HDL 130% failed clinical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200507 -            trial Eli Lilly cholesterol drug CEPT inhibitor did not                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200508 -            reduce CV events; raised blood pressure (hypertension),                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200509 -            ref SDS 4 AF51  Doctors discouraged Merck anacetrapib and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200510 -            Amgen TA-8995 which raise HDL similarly, expect fail to                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200511 -            improve clinical outcomes. ref SDS 4 OH42                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200512 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200513 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200514 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200515 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200517 -  ..
2006 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
2007 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
2008 - Progress                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
2009 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
200901 - Cholesterol was an issue during examination at the VA on 100721 0800.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200902 - ref SDS 1 3X4L  Lab on 100721 found significant rise in cholesterol.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200903 - ref SDS 1 E19L                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200905 -  ..
200906 - Received through the Internet....                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
200908 -     ..
200909 -    Next big thing? Big cholesterol drop with new drug                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
200910 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200911 -    Associated Press                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
200913 -     ..
200914 -    By MARILYNN MARCHIONE, AP Medical Writer Marilynn Marchione,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200915 -    Ap Medical Writer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200916 -    Wed Nov 17, 9:29 am ET                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
200918 -         ..
200919 -    1.  CHICAGO - An experimental Merck drug safely boosted good                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200920 -        cholesterol to record highs while dropping bad cholesterol to                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200921 -        unprecedented lows in a study that stunned researchers and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
200922 -        renewed hopes for an entirely new way of lowering heart risks.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200924 -         ..
200925 -    2.  "We are the most excited we have been in decades" about a novel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
200926 -        drug, said the study's leader, Dr Christopher Cannon, of                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200927 -        Brigham and Women's Hospital in Boston. "This could really be                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200928 -        the next big thing."                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
200929 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200930 -            [On 101223 1030 meeting with primary care physician at VA                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
200931 -            did not discuss Merck's new drug anacetrapib for lowering                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200932 -            cholesterol. ref SDS 2 PM5F                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
200934 -             ..
200935 -            [On 131017 1000 meeting with Doctor Egan consider clinical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
200936 -            trial with anacetrapib to lower cholesterol without severe                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200937 -            side effects caused by statins. ref SDS 3 179N                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200939 -             ..
200940 -            [On 160405 1305 Evacetrapib raised HDL 130% failed clinical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200941 -            trial Eli Lilly cholesterol drug CEPT inhibitor did not                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200942 -            reduce CV events; raised blood pressure (hypertension),                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200943 -            ref SDS 4 AF51  Doctors discouraged Merck anacetrapib and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200944 -            Amgen TA-8995 which raise HDL similarly, expect fail to                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200945 -            improve clinical outcomes. ref SDS 4 OH42                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200946 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200948 -         ..
200949 -    3.  The drug, anacetrapib (an-uh-SEHT'-ruh-pihb), won't be on the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200950 -        market anytime soon.  It needs more testing to see if its                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200951 -        dramatic effects on cholesterol will translate into fewer heart                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
200952 -        attacks, strokes and deaths.  Merck & Co. announced a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200953 -        30,000-patient study to answer that question and it will take                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200954 -        several years.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200956 -         ..
200957 -    4.  But the sheer magnitude of its effects so far caused big                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200958 -        excitement at an American Heart Association conference in                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200959 -        Chicago, where results were presented on Wednesday.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200961 -         ..
200962 -    5.  "The data look spectacular, beyond what anybody would have                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
200963 -        expected," said Dr Robert Eckel, a University of Colorado                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200964 -        cardiologist and past president of the heart association. "It's                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
200965 -        like a rocket to Jupiter versus one to the moon.  I can think                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200966 -        of many of my patients who could use the drug right now."                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200968 -         ..
200969 -    6.  Merck's Dr Luciano Rossetti agreed.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
200970 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
200971 -        "We are trying not to be too giddy. The potential benefit is                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
200972 -        enormous," said Rossetti, senior vice president of global                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
200973 -        scientific strategy at the company, based in Whitehouse                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
200974 -        Station, N.J.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200976 -         ..
200977 -    7.  For years, doctors have focused on lowering LDL, or bad                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
200978 -        cholesterol, to cut heart risks.  Statin medicines, sold as                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200979 -        Lipitor, Zocor and in generic form, do this.  But many statin                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200980 -        users still suffer heart attacks, so doctors have been trying                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200981 -        to get LDL to very low levels and to boost HDL, or good                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
200982 -        cholesterol.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
200984 -         ..
200985 -    8.  Anacetrapib would be the first drug of its kind. It helps keep                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200986 -        fat particles attached to HDL, which carries it in the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
200987 -        bloodstream to the liver to be disposed of.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200989 -         ..
200990 -    9.  The Merck-sponsored study tested it in 1,623 people already                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
200991 -        taking statins because they are at higher than usual risk of a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
200992 -        heart attack - half had already had one, and many others had                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
200993 -        conditions like diabetes.  An LDL of 100 to 129 is considered                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200994 -        good for healthy people, but patients like these should aim for                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
200995 -        under 100 or even under 70, guidelines say. For HDL, 40 to 59                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
200996 -        is OK, but higher is better.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
200998 -         ..
200999 -   10.  After six months in the study:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
201000 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
201001 -        _LDL scores fell from 81 to 45 in those on anacetrapib, and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201002 -        from 82 to 77 in those given dummy pills.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
201004 -         ..
201005 -        HDL rose from 41 to a whopping 101 in the drug group, and from                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
201006 -        40 to 46 in those on dummy pills.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
201007 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
201008 -            [On 160405 1305 Evacetrapib raised HDL 130% failed clinical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
201009 -            trial Eli Lilly cholesterol drug CEPT inhibitor did not                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201010 -            reduce CV events; raised blood pressure (hypertension),                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201011 -            ref SDS 4 AF51  Doctors discouraged Merck anacetrapib and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
201012 -            Amgen TA-8995 which raise HDL similarly, expect fail to                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201013 -            improve clinical outcomes. ref SDS 4 OH42                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
201015 -         ..
201016 -   11.  Such large changes have never been seen before, doctors say,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
201017 -        and these improvements persisted for at least another year that                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201018 -        the study went on.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
201020 -         ..
201021 -   12.  The study was too small to tell whether anacetrapib lowered                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201022 -        deaths, heart attacks or other heart problems, but the trend                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
201023 -        was in the right direction, with fewer of those cases among                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201024 -        patients on the drug.  The anacetrapib group also needed                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
201025 -        significantly fewer procedures to fix clogged arteries.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
201027 -         ..
201028 -   13.  Importantly, there were no signs of the blood pressure problems                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201029 -        that led Pfizer Inc. to walk away from an $800 million                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
201030 -        investment in torcetrapib, a similar drug it was developing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
201031 -        four years ago.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201033 -         ..
201034 -   14.  "This one looks far more potent, without the serious side                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
201035 -        effects that led to failure," Dr.  W.  Douglas Weaver, a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
201036 -        cardiologist at Henry Ford Health System in Detroit and past                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
201037 -        president of the American College of Cardiology, said of the                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
201038 -        new Merck drug. "If proven effective, this will really change                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
201039 -        practice in the same way aspirin and statins have."                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
201041 -         ..
201042 -   15.  Results of the study also were published online by the New                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
201043 -        England Journal of Medicine.  Some study leaders have consulted                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201044 -        for Merck and makers of other heart drugs.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
201046 -         ..
201047 -   16.  The only other drug that has had major effects on bad and good                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
201048 -        cholesterol - albeit much smaller than those from anacetrapib -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201049 -        is niacin, a type of B vitamin sold in an extended-release                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
201050 -        version as Niaspan by Kos Pharmaceuticals Inc.  It has been on                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
201051 -        the market since the late 1990s, but some people are bothered                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
201052 -        by a prickly-hot sensation called flushing. Doctors say this                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
201053 -        side effect can be minimized by taking the drug at night with a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
201054 -        low-fat snack.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
201055 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
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201071 -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
2011 -