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PPI Omeprazole Side Effects PLOS One Study Reports 16%-21% Increased
2503 -
2503 - ..
2504 - Summary/Objective
2505 -
250501 - Follow up ref SDS 53 0000. ref SDS 51 0000.
250502 -
250503 -
250504 -
250505 -
250507 - ..
2506 -
2507 -
2508 - Background
2509 -
250901 - EGD on 101210, seems to show progress recovering from esophagitis; the
250902 - doctor dilated the LESV from 11 to 14 cm, reported on 101210 0930,
250903 - ref SDS 49 XG6J
250905 - ..
250906 - Follow up EGD planned for February, ref SDS 49 L94L.
250908 - ..
250909 - On 101210 Doctor Lee prescribed doubling dose of Omeprazole to increse
250910 - recover from esophagitis. ref SDS 49 ZN4M
250912 - ..
250913 - On 101216 requested assistance ordering refill for Omeprazole.
250914 - ref SDS 51 K44P
250916 - ..
250917 - On 101218 recognized rising symptoms of side effects caused by
250918 - Omeprazole. ref SDS 52 8Q5I
250920 - ..
250921 - On 101219 1402 submitted letter to medical team reporting rising side
250922 - effects of Omeprazole, ref SDS 53 5N3O, and reqquested adjustments.
250924 - ..
250925 - On 150611 0713 article reports PPI (Omeprazole) has side effects of
250926 - damaging endothelial lining of blood vessels, ref SDS 0 VC5O, and
250927 - further finds patients taking PPI drugs (Omeprazole) suffered 16-21%
250928 - increased risk of myocardial infarction (heart attack). ref SDS 0 ZB96
250929 -
250930 -
250931 -
250932 -
250933 -
250935 - ..
2510 -
2511 -
2512 - Progress
2513 -
251301 - Article published by Eurekalert...
251302 -
251303 - Eurekalert
251304 - The Global Source for Science News
251306 - ..
251307 - PUBLIC RELEASE: 10-JUN-2015
251309 - ..
251310 - Heart attack risk increases 16-21 percent with use of common antacid
251311 -
251312 - HOUSTON METHODIST
251313 -
251314 - http://www.eurekalert.org/pub_releases/2015-06/hm-har060415.php
251316 - ..
251317 - 1. HOUSTON -- ( June 4, 2015 ) - Adults who use proton pump
251318 - inhibitors are between 16 and 21 percent more likely to
251319 - experience a heart attack than people who don't use the
251320 - commonly prescribed antacid drugs, according to a massive new
251321 - study by Houston Methodist and Stanford University scientists.
251323 - ..
251324 - 2. An examination of 16 million clinical documents representing
251325 - 2.9 million patients also showed that patients who use a
251326 - different type of antacid drug called an H2 blocker have no
251327 - increased heart attack risk. The findings, reported in PLOS
251328 - ONE, follow a Circulation report in 2013 in which scientists
251329 - showed how -- at a molecular level -- PPIs might cause
251330 - long-term cardiovascular disease and increase a patient's heart
251331 - attack risk.
251333 - ..
251334 - 3. "Our earlier work identified that the PPIs can adversely affect
251335 - the endothelium, the Teflon-like lining of the blood vessels,"
251336 - said John Cooke, M.D., Ph.D., a senior author of the PLOS ONE
251337 - report. "That observation led us to hypothesize that anyone
251338 - taking PPIs may be at greater risk for heart attack.
251339 - Accordingly, in two large populations of patients, we asked
251340 - what happened to people that were on PPIs versus other
251341 - medications for the stomach."
251343 - ..
251344 - PPI adverse effects to endothelium lining of blood vessels adds to
251345 - adverse side effects taking Omeprazole, originally reviewed on 101218
251346 - 1642. ref SDS 52 8Q5I
251348 - ..
251349 - Coronary CT angiography has been considered to evaluate damage to
251350 - endothelium lining of blood vessels from elevated cholesterol,
251351 - reported in research on 131125 0005. ref SDS 55 N73K
251353 - ..
251354 - This current PLOS One study citing correlation between PPI
251355 - (Omeprazole) and adverse affects to endothelium with possible
251356 - consequent increase in myocardial infarction (heart attack) adds
251357 - weight to evidence support for ordering lab on EPCs and CCTA testing.
251359 - ..
251360 - Recent disclosure of Dor fundoplication protections against reflux
251361 - having "unraveled," reported during meeting with Doctor Lee at VAMC
251362 - Sacramento on 150319, ref SDS 57 KN6F, has led to increased use of PPI
251363 - (Omeprazole) to maintain reflux protection against ulceration of LESV,
251364 - also cited by Doctor Lee on 150319. ref SDS 57 TB5I
251366 - ..
251367 - On 150526, Doctor Stewart presented challenges to redo Dor
251368 - fundoplication with laparoscopic surgery to restore protections
251369 - against reflux, thus allowing reduced use of PPI. ref SDS 59 L44F
251370 - These risks augar against correcting Dor fundoplication, and treating
251371 - the problem of reflux causing ulcertion of LESV by increasing PPI
251372 - from current 2 pills to 4 pills per day. This is supported in part
251373 - by Doctor Lee's Progress Notes for EGD Dilation on 15041 finding
251374 - reduced ulceration of LESV following increased use of PPI in response
251375 - to rising reflux.
251377 - ..
251378 - The PLOS One study suggests that increasing PPI may increase risk of
251379 - myocardial infarction through damaging endothelial lining of blood
251380 - vessels, further increases requirements for lab to evaluate for
251381 - elevated EPCs that compliment elevated HDL the past 18 months
251383 - ..
251384 - Increased endurance exercise the past few years, reported in case
251385 - study of patient history on 140101 0600, ref SDS 56 XY4M, may have
251386 - increased producton of EPCs and HDL in sufficient amount to prevent
251387 - and repair damage to endothelium lining of blood vessels, shown by
251388 - research on 131125 0005. ref SDS 55 R44O If so, this would suggest
251389 - protection against adverse effects of increasing Omeprazole currently
251390 - considered for protecting against adverse effects of Dor
251391 - fundoplication unraveling.
251393 - ..
251394 - CCTA to determine damage to endothelium lining of blood vessels with
251395 - plaque build can establish if PPI can be increased to avoid redo
251396 - fundoplication.
251398 - ..
251399 - CCTA was discussed with Doctor Lee on 150319 0800. ref SDS 57 GB56 On
251400 - 150323 1926 letter to Doctor Lee provided access to this record
251401 - listing requested research on coronary CTA. ref SDS 58 WV3H At that
251402 - time on 150319, correlations between Omeprazole and 16%-21% increased
251403 - of myocardial infarction were not known. The new study today, may add
251404 - urgency to evaluate effects of Omeprazole, in light of other rising
251405 - side effects taking Omeprazole, originally reviewed on 101218 1642.
251406 - ref SDS 52 8Q5I
251407 -
251409 - ..
251410 - Article continues...
251411 -
251412 - 4. The PLOS ONE study's principal investigator was Stanford
251413 - vascular medicine specialist Nicholas J. Leeper, M.D.
251415 - ..
251416 - 5. In the present study, the researchers found a clear and
251417 - significant association between exposure to PPIs and the
251418 - occurrences of heart attack.
251420 - ..
251421 - 6. "By looking at data from people who were given PPI drugs
251422 - primarily for acid reflux and had no prior history of heart
251423 - disease, our data-mining pipeline signals an association with a
251424 - higher rate of heart attacks," said the PLOS ONE report's lead
251425 - author, Nigam H. Shah, Nigam H. Shah, M.B.B.S., Ph.D., an
251426 - assistant professor of biomedical informatics at Stanford,
251427 - where the work was done. "Our results demonstrate that PPIs
251428 - appear to be associated with elevated risk of heart attack in
251429 - the general population, and H2 blockers show no such
251430 - association."
251432 - ..
251433 - 7. The estimated increase of heart attack risk ranges from 16 to
251434 - 21 percent, because of uncertainty in the estimation process,
251435 - Shah said.
251437 - ..
251438 - 8. The FDA estimates about 1 in 14 Americans has used proton pump
251439 - inhibitors. In 2009, PPIs were the third-most taken type of
251440 - drug in the U.S., and are believed to account for $13 billion
251441 - in annual global sales. Doctors prescribe PPIs to treat a wide
251442 - range of disorders, including gastro-esophageal reflux disease,
251443 - or GERD, infection by the ulcer-causing bacterium Helicobacter
251444 - pylori, Zollinger-Ellison syndrome, and Barrett's esophagus.
251445 - The drugs can also be purchased over the counter. PPIs come in
251446 - a variety of slightly different chemical forms, always ending
251447 - with the suffix "-prazole," for example, omeprazole or
251448 - lansoprazole. Brand examples of PPIs are Nexium, Prilosec, and
251449 - PrevAcid.
251451 - ..
251452 - 9. H2 blockers are another type of antacid drug. They are not
251453 - believed to be associated with increased risk of heart attack
251454 - or cardiovascular disease. Examples of the drug are cimetidine
251455 - and ranitidine. Brand examples of H2 blockers are Zantac and
251456 - Tagamet.
251458 - ..
251459 - 10. The researchers collected data from two repositories -- STRIDE
251460 - (Stanford Translational Research Integrated Database
251461 - Environment), which contains information about 1.8 million
251462 - Stanford hospital and clinic patients, and a subset of
251463 - information for 1.1 million patients from the Web-based
251464 - electronic medical records company Practice Fusion, Inc. Both
251465 - sources of patient information were anonymized before the
251466 - researchers accessed the data.
251468 - ..
251469 - 11. The group scanned the databases for patients who were
251470 - prescribed proton pump inhibitors or other drugs, such as H2
251471 - blockers, and also looked to see if a given patient had a
251472 - mention of having experienced a major cardiovascular event,
251473 - such as myocardial infarction (heart attack), in their medical
251474 - record.
251476 - ..
251477 - 12. Patients who had used PPIs were found to be at
251478 - 1.16-1.21-fold-increased risk of heart attack.
251480 - ..
251481 - 13. Scrutiny of PPIs has only increased with time. Initially it was
251482 - believed PPIs only posed a risk to a very narrow subset of
251483 - patients -- those with coronary artery disease who were using
251484 - the anti-platelet drug clopidogrel to prevent future heart
251485 - attacks.
251487 - ..
251488 - 14. "Investigators originally assumed this was due to a drug-drug
251489 - interaction between these compounds, and the FDA went so far as
251490 - to release a warning about their concomitant use," said
251491 - Nicholas Leeper.
251493 - ..
251494 - 15. A 2013 report to Circulation by several of the present report's
251495 - coauthors, including Cooke, raised the possibility that PPIs
251496 - could lead to cardiovascular disease in the general population.
251498 - ..
251499 - 16. "This led us to use powerful 'big-data' approaches to try to
251500 - determine whether PPIs might in fact be associated with risk in
251501 - 'all comers,' Leeper said. "Our report raises concerns that
251502 - these drugs -- which are available over the counter and are
251503 - among the most commonly prescribed drugs in the world -- may
251504 - not be as safe as we previously assumed."
251506 - ..
251507 - 17. In the future, the researchers say they hope to conduct a
251508 - large, prospective, randomized trial to determine whether PPIs
251509 - are harmful to a broader population of patients.
251510 -
251511 - *********************
251513 - ..
251514 - 18. Also contributing to the PLOS ONE report were co-lead author
251515 - Paea LePendu, Anna Bauer-Mehren, Srinivasan V. Iyer, and Kevin
251516 - T. Nead (Stanford University), Yohannes T. Ghebremariam
251517 - (Houston Methodist), and Jake Marcus (Practice Fusion, Inc.).
251518 - Research was funded by grants from the National Institutes of
251519 - Health (U54HG004028, U54LM008748, and 1U01HL100397), the
251520 - American Heart Association (11IRG5180026), Apixio, Inc., and
251521 - the Stanford SPARK Translational Research Program.
251523 - ..
251524 - 19. To speak with Dr John Cooke, please contact David Bricker,
251525 - Houston Methodist, at 832-667-5811 or
251526 - dmbricker@houstonmethodist.org. To speak with Drs. Shah and
251527 - Leeper, please contact Bruce Goldman, Stanford University, at
251528 - 650-725-2106 or goldmanb@stanford.edu.
251530 - ..
251531 - 20. "Proton pump inhibitor usage and the risk of myocardial
251532 - infarction in the general population," by Nigam H. Shah et al,
251533 - PLOS ONE
251535 - ..
251536 - 21. Disclaimer: AAAS and EurekAlert! are not responsible for the
251537 - accuracy of news releases posted to EurekAlert! by contributing
251538 - institutions or for the use of any information through the
251539 - EurekAlert system.
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