Omeprazole might help reduce stomach problems for heart patients

By Rachel Donihoo / Holidays 2010

Use of the popular stomach acid-reduction drug omeprazole (Prilosec) appears to decrease significantly the rate of upper gastrointestinal bleeding in heart patients taking aspirin and the blood thinner clopidogrel (Plavix), according to a study involving a
UT Southwestern researcher and published in the New England Journal of Medicine.

Findings from the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT) suggest that a dual therapy of omeprazole, a proton-pump inhibitor, and clopidogrel, a blood-clot inhibitor, greatly reduces the risk of gastrointestinal bleeding without raising the risk of heart attack.

The findings challenge the Food and Drug Administration’s 2009 advisory against the drug combination, said Dr. Byron Cryer, professor of internal medicine and a study co-author.

“Prilosec, which is among the most commonly prescribed medications in this country, appears to have a marked benefit for heart patients taking Plavix and aspirin,” Dr. Cryer said. “In light of these findings, we think that the FDA would want to re-evaluate its position on clopidogrel and omeprazole as a dual therapy. Not only does clopidogrel appear to blunt the gastrointestinal side effects of blood thinners; it does not appear to increase a patient’s risk of heart attack — a complication that has long been feared.”

Gastrointestinal side effects are a common problem for patients with coronary artery disease undergoing antithrombotic, or blood-thinning, therapy, Dr. Cryer said. Proton-pump inhibitors such as omeprazole can be used to counteract the symptoms by inhibiting the ability of cells lining the stomach to produce gastric acid.

COGENT, an international, randomized double-blind phase II study, assessed the safety and efficacy of omeprazole in 3,761 patients with coronary artery disease who were already taking clopidogrel plus aspirin. The study subjects were enrolled at 393 sites in 15 countries, randomly assigned to add either omeprazole (1,876 patients) or placebo (1,885 patients) to their treatment regimen. Researchers followed the participants for a median of 106 days (341 days maximum). The median age was 69 in both groups.

Participants who did not take omeprazole were twice as likely to experience gastrointestinal bleeding events as those who received the medication, Dr. Cryer said. In addition, omeprazole decreased the symptoms of gastroesophageal reflux disease.

“Further research will be necessary to determine the optimal approach to reducing the risk of GI side effects among patients receiving potent antithrombotic therapy,” said Dr. Cryer, who is the chairman of the executive committee of COGENT.

Harvard University researchers led the study, which was supported by Cogentus Pharmaceuticals. Investigators from the VA Boston Healthcare System, Brigham and Women’s Hospital, Newark Beth Israel Medical Center, the University of Zargoza, Northwestern University Feinberg School of Medicine, Parexel International, and the University of Southern California also contributed to the study.

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Dr. Cryer holds the John C. Vanatta III Professorship.