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SCAI Statement on 'A National Study of the Effect of Individual Proton Pump Inhibitors on Cardiovascular Outcomes in Patients Treated with Clopidogrel Following Coronary Stenting: The Clopidogrel Medco Outcomes Study'
Date:5/6/2009

LAS VEGAS, May 6 /PRNewswire/ -- Results of the Clopidogrel Medco Outcomes Study presented today during SCAI's Annual Scientific Sessions found the anti-clotting benefits of clopidogrel (Plavix) may be reduced when taken concurrently with commonly used heartburn medications called proton pump inhibitors (PPIs). In the study, patients taking clopidogrel and a PPI experienced a:

  • 50% increase in the combined risk of hospitalization for heart attack, stroke, unstable angina, or repeat revascularization, including:
    • 70% increase in the risk of heart attack or unstable angina
    • 48% increase in the risk of stroke or stroke-like symptoms
    • 35% increase in the need for a repeat coronary procedure

Dual antiplatelet therapy, which commonly consists of clopidogrel and aspirin, is routinely prescribed to patients following insertion of stents to prevent life-threatening blood clots. PPIs are also frequently prescribed to these patients for brief periods (approximately 30 days) following stent insertion to treat unpleasant but non-life-threatening side effects of clopidogrel such as nausea. In some patients PPIs may also be taken routinely for gastrointestinal conditions like peptic ulcer disease.

The Clopidogrel Medco Outcomes Study is the largest to date to examine the outcomes of patients who are taking clopidogrel and a PPI. However, two smaller, earlier studies came to opposite conclusions concerning adverse effects when patients were taking both medications. The first study, a database analysis, found an increase in cardiac events in patients taking clopidogrel along with a PPI, while the CREDO study found no adverse effect when clopidogrel was taken along with a PPI.

The current study examined outcomes of patients taking common PPI medications including pantoprazole (Protonix), esomeprazole (Nexium), omeprazole (Prilosec), and lansoprazole (Prevacid). It did not review outcomes in patients taking any of the newer PPIs, such as rabeprazole (Aciphex) or dexlansoprazole (Kapidex). Patients in the study took PPIs for an average of nine months.

SCAI believes more research is needed on this topic. However, given the thousands of patients who receive stents each year, coupled with the significant risks demonstrated in this study, SCAI recommends the use of alternative medications for GI symptoms in patients with stents when appropriate. Other effective treatments for heartburn and ulcers include histaminergic (H2) blockers (Zantac, Tagamet) or antacids. In some patients the use of PPIs may still be warranted based on the patient's medical problems and should be taken at the direction of the patient's cardiologist, gastroenterologist or primary physician.

Importantly, patients should never stop taking any prescribed medication without first discussing with their doctor. Guidelines authored by SCAI and other cardiovascular organizations recommend dual-antiplatelet therapy for no less than one year following stent implantation. Clinical trials have shown this drug regimen effectively prevents blood clots that can lead to rare but potentially life-threatening cardiac events.


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SOURCE SCAI
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