COGENT: No adverse CV interaction with clopidogrel, PPIs

TCT 2009

Results from the late-breaking COGENT trial indicated that there were no clinically relevant adverse cardiovascular interactions between the use of clopidogrel and omeprazole in patients with acute coronary syndromes undergoing PCI. The results of the trial, presented by Deepak L. Bhatt, MD, MPH, of Brigham and Women’s Hospital, Boston, also showed that prophylactic use of PPIs resulted in the prevention of GI events in these patients.

The results of the trial were presented at Transcatheter Cardiovascular Therapeutics 2009 in San Francisco last week.

COGENT is a multicenter, prospective trial in which researchers randomly assigned 3,627 patients with acute coronary syndromes receiving PCI and subsequent antiplatelet therapy to either the PPI omeprazole or placebo. They followed patients for 133 days. One hundred and thirty-six adjudicated CV events and 105 adjudicated gastrointestinal events occurred, according to Bhatt.

There were no differences in clinical CV endpoints of CV death and MI between the two groups (HR=1.02; 95% CI, 0.70-1.51).

Gastrointestinal events were defined as gastrointestinal bleeding, symptomatic ulcer disease, obstruction or perforation. Patients assigned to omeprazole had a lower composite number of these events (38 vs. 67 for placebo; HR=0.55; 95% CI, 0.36-0.85).

Two observational trials, published earlier this year, had opposing conclusions about the interaction between clopidogrel and PPIs. Ho et al showed that concomitant use of the drugs was associated with an increased risk of adverse CV events; however, results from the TRITON-TIMI 38 trial indicated that the use of a PPI did not increase adverse events among these patients.

For more information:

Bhatt D. COGENT: A Prospective, Randomized, Placebo-Controlled Trial of Omeprazole in Patients Receiving Aspirin and Clopidogrel. Presented at: Transcatheter Cardiovascular Therapeutics; Sept. 21-15, 2009; San Francisco.