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
..............
Click here to comment!
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 -
201056 -
201057 -
201058 -
201059 -
201060 -
201061 -
201062 -
201063 -
201064 -
201065 -
201066 -
201067 -
201068 -
201069 -
201070 -
201071 -
2011 -