This article is more than 5 years old. Information may no longer be current.
COGENT: PPI use reduced rate of gastrointestinal bleeding in patients given clopidogrel, aspirin
Bhatt D. N Engl J Med. 2010;doi:10.1056/nejmoa1007964.
Click Here to Manage Email Alerts
Patients given a proton pump inhibitor besides clopidogrel and aspirin had a reduced rate of upper gastrointestinal bleeding, new results from the COGENT trial have indicated. Furthermore, researchers also reported no apparent CV interaction between clopidogrel and omeprazole.
“Proton pump inhibitors are believed to decrease the risk of [gastrointestinal] complications, though no randomized trial has proved this in patients receiving dual antiplatelet therapy. Recently, concerns have been raised about the potential for PPIs to blunt the efficacy of clopidogrel,” the researchers wrote.
They initiated the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT) to bring further clarification to this concern by assessing the efficacy and safety of administration of proton pump inhibitors in patients (n=3,761) with CAD who were receiving clopidogrel plus aspirin. Patients were included if they were at least 21 years and anticipating use of clopidogrel therapy with concomitant aspirin for at least 12 months.
Overall, 51 patients had a gastrointestinal event, with an event rate at 180 days of 1.1% in the omeprazole arm and 2.9% in the placebo arm (omeprazole HR=0.34; 95% CI, 0.18-0.63). Study results also indicated reduction in the rate of overt upper gastrointestinal bleeding with omeprazole vs. placebo (HR=0.13; 95% CI, 0.03-0.56).
Similarly, in the 109 patients who had a CV event, the event rate was lower in the omeprazole group (4.9% vs. 5.7%); however, this reduction was not statistically significant (omeprazole HR=0.99; 95% CI, 0.68-1.44).
Limitations of note, according to the researchers, were the premature termination of the trial, the wide CI around the HR for CV events, leading to an indefinite finding, and the single-pill formulation used that differs from generic omeprazole with respect to its release kinetics.
This randomized assessment, the researchers concluded, “provides reassurance that there is no clinically significant CV interaction between proton pump inhibitors and clopidogrel, whereas there is a significant reduction in gastrointestinal bleeding with PPI use as compared with placebo. Further research will be necessary to determine the optimal approach to reducing the risk of gastrointestinal adverse events among patients receiving potent antithrombotic therapy, but prophylactic proton pump inhibition appears to be promising.”
 |
Follow CardiologyToday.com on Twitter. |