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January 26, 2009 -- 2:30pm EST Plavix, Prilosec, Prevacid, Protonix -- Do I
Hear a Nexium? The basic concern is that some recent studies have questioned whether the effectiveness of Plavix may be compromised by a group of drugs known as Proton Pump Inhibitors (PPI). Presented as an abstract at the AHA in November, a major study by Medco, the nation's leading pharmacy benefit manager, looked at almost 17,000 patient benefit records and found a 74% increase in heart attacks in patients taking both Plavix and PPIs together. These include the drugs in my title, plus a few more. (Compounding the concern is that Prilosec is also available over-the-counter.) PPIs are often prescribed for patients who are taking Plavix, because Plavix, especially when taken with aspirin, can cause upset stomach and gastric bleeding and these PPIs are effective in reducing those adverse reactions. The problem is that PPIs may also inhibit the enzyme that activates clopidogrel. While some studies have shown this to be true, others have not. Also, this is not the first time that Proton Pump Inhibitors have come under review by the FDA. In August 2007, the FDA started a review, based on some small studies showing an increase in heart problems. But the clopidogrel connection was not involved there. One of the problems is that all drug eluting stent patients are required to take aspirin and clopidogrel for a year, at least. Stopping prematurely can lead to stent thrombosis (blood clots in the stent) and heart attack or death. So, if a drug is found to inhibit Plavix, it could be dangerous. However, the CREDO study, also presented at this year's AHA, found that there was no interaction, that patients taking PPIs showed an increase in cardiovascular events at one-year whether the patient was on Plavix or not. And that Plavix had a beneficial effect in reducing cardiovascular events whether the patient was taking PPIs or not. Confused? The conflicting results between these two major studies prompted the AHA, ACC and American College of Gastroenterology to issue a statement to patients not change their medications without consulting their clinician. The SCAI also issued a similar statement, and concluded by stating:
Unfortunately, Cogentus Pharmaceuticals, the company sponsoring the COGENT-1 trial announced on Thursday that it is filing for bankruptcy and that the trial was being terminated. Still confused? Wait....other recent studies have also shown various genetic markers which indicate not all patients process Plavix efficiently -- this is not news to those who have been discussing "Plavix resistance" in some patients for some time. So many questions about a drug that every stent patient must take! In today's notice, the FDA recommends:
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