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| |  ACC/AHA Comments on Possible Interaction of Clopidogrel, PPIs WASHINGTON, DC -- November 13, 2008 -- Two studies presented at the American Heart Association (AHA) Scientific Sessions came to opposite conclusions in studying whether proton pump inhibitors (PPIs) alter the ability of clopidogrel to prevent cardiovascular events after stent placement. Guidelines and statements by the American College of Cardiology (ACC) and the AHA recommend dual antiplatelet therapy following stent placement. Previous research shows that combining a PPI with clopidogrel lessens the risk of gastrointestinal (GI) bleeding. However, other recent studies have suggested that adding a PPI could blunt clopidogrel's anti-platelet effect. This interaction has not been studied in large numbers of patients, so there is no definitive evidence that the use of PPIs will keep clopidogrel from working to prevent cardiac events. Neither of the studies presented provide sufficient evidence to change clinical practice. The first study (abstract #3998) reviewed major adverse cardiac events over 1 year in patients prescribed clopidogrel after stent placement. The study group included 14,383 patients in the Medco Integrated Database who were at least 80% compliant with refilling their medication. Patients who took clopidogrel alone were compared with those taking clopidogrel and PPIs. The study found that patients receiving both medications had significantly more major cardiovascular events in 1 year than patients taking clopidogrel alone. However, the patients taking both medications had a higher cardiovascular risk factor profile. There are several significant limitations to this type of study, as acknowledged by the authors. The database did not include information about participants' use of over-the-counter drugs (including aspirin or omeprazole) and could not account for other cardiovascular risk factors such as family history, smoking status, blood pressure levels, and lipid values. As the authors themselves concluded, further investigation should focus on prospective study of this interaction. The second study (abstract #3999) reported no adverse effect of combining a PPI with clopidogrel. Clopidogrel for the Reduction of Events During Observation (CREDO) previously found a benefit of 1 year versus 1 month of treatment with clopidogrel after coronary stenting. The subgroup analysis assessed the endpoint of death, heart attack, or stroke in patients on clopidogrel or placebo with or without a PPI, and showed no adverse effect of combining a PPI with clopidogrel. Patients treated with a PPI were at higher baseline risk and had a worse outcome compared to those who were not, whether they were given placebo or clopidogrel. The ongoing Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1) study should help answer some of these questions. The trial is randomising patients with coronary artery disease to aspirin plus clopidogrel in combination with 20 mg of omeprazole or placebo, and should provide further evidence to help address these issues. Other clinical trials are needed to fully explore this issue.
SOURCE: American College of Cardiology
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