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COGENT: Proton-pump inhibitors may offer gastroprotection to patients requiring DAPT

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CHICAGO — A post hoc analysis of data from the COGENT study suggested that proton-pump inhibitors may reduce gastrointestinal events in patients requiring dual antiplatelet therapy, even if they are on a low dose of aspirin.

The new data were presented at the American College of Cardiology Scientific Session and simultaneously published in the Journal of the American College of Cardiology.

Muthiah Vaduganathan, MD, MPH , of Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, and colleagues randomized 3,752 patients from the initial COGENT trial into low-dose (100 mg) and high-dose (>100 mg) aspirin groups to assess the safety and efficacy of proton-pump inhibitors in this population.

Patients in the low-dose aspirin group (n = 2,480) were predominantly female and older. They were also more likely to have peripheral artery disease, prior stroke and hypertension. Those in the high-dose aspirin group (n = 1,272), on the other hand, were more likely to be smokers and to have had previous PCI, according to the researchers.

The primary gastrointestinal endpoint was a composite of upper gastrointestinal events. Rates of gastroesophageal reflux disease and non-gastrointestinal bleeding were also measured. The primary CV endpoint was major adverse cardiac events, a composite of CV death, nonfatal MI, coronary revascularization and ischemic stroke. Patients were followed for approximately 110 days.

Both groups of aspirin users had similar rates of composite gastrointestinal events (high dose, 1.7%; low dose, 2.1%; adjusted HR = 0.88; 95% CI, 0.46-1.66) and major adverse cardiac events (high dose, 4.8%; low dose, 5.5%; adjusted HR = 0.73; 95% CI, 0.48-1.11), according to the results.

Proton-pump inhibitors reduced the primary gastrointestinal endpoint in both the low-dose aspirin group (1.2% vs. 3.1%; P =.003) and the high-dose aspirin group (0.9% vs. 2.6%; P = .05; P for interaction = .8). The number needed to treat to prevent one major composite upper GI event with 6 months of proton-pump inhibitory therapy was 52 in the low-dose aspirin group and 58 in the high-dose aspirin group. No increases in the rate of major adverse cardiac events were observed.

Vaduganathan and colleagues wrote that “[proton-pump inhibitor] use appears to be underutilized for prevention of gastrointestinal events, perhaps related to underestimated clinician estimates of gastrointestinal risks related to low-dose aspirin.” – by Tracey Romero

Reference s :

Vaduganathan M, et. al. Abstract 1240M-03. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Vaduganathan M, et al. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2015.12.068.

Disclosure: The COGENT trial was funded by Cogentus Pharmaceuticals. Vaduganathan reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures.