Proton-pump inhibitors reduce GI events even with low-dose aspirin

Reuters Health Information: Proton-pump inhibitors reduce GI events even with low-dose aspirin

Proton-pump inhibitors reduce GI events even with low-dose aspirin

Last Updated: 2016-04-06

By Will Boggs MD

NEW YORK (Reuters Health) - Proton-pump inhibitors (PPIs) reduce gastrointestinal (GI) events even in patients taking low-dose aspirin as part of dual antiplatelet therapy (DAPT), according to a post-hoc analysis from the COGENT trial.

"While chronic low-dose (versus high-dose) aspirin for secondary prevention seems to be a reasonable strategy to lower GI bleeding risk (based on other studies), use of low-dose aspirin does not attenuate the protective effect of PPIs on GI bleeding," said Dr. Deepak L. Bhatt from Brigham and Women's Hospital, Harvard Medical School, Boston.

"COGENT was the first randomized trial to show that prophylactic PPIs reduce clinical (as opposed to endoscopic) GI bleeding in patients who were not at particularly high risk of GI bleeding, other than being on dual antiplatelet therapy," he told Reuters Health by email.

Dr. Bhatt and colleagues used data from more than 3,700 patients in the COGENT study to determine the overall GI and cardiovascular safety and efficacy of PPI therapy in patients on low-dose (75 mg or 81 mg daily; n=2,480) and high-dose (150 mg, 162 mg, 300 mg, or 325 mg; n=1,272) aspirin.

PPIs reduced the primary GI endpoint from 3.1% to 1.2% in those on low-dose aspirin and from 2.6% to 0.9% in the high-dose aspirin group. For six months of PPI therapy, the number needed to treat to prevent one major composite upper GI event was 52 with low-dose aspirin and 58 with high-dose aspirin.

PPI use consistently reduced the risk of each component of the primary GI endpoint in both aspirin-dosing groups, the researchers report in the Journal of the American College of Cardiology, online March 21.

PPI therapy was not associated with significant changes in the primary cardiovascular endpoint or in the low rates of non-GI bleeding and all-cause mortality in either subgroup of aspirin dosing.

The risks of composite upper GI events, gastroesophageal reflux disease (GERD), and major adverse cardiovascular events (MACE) at 180 days were similar in the low-dose and high-dose aspirin groups.

Older age was the only independent predictor of composite upper GI events, and randomization to omeprazole (versus placebo) was independently associated with lower risk of the composite primary GI endpoint.

"In addition to considering ischemic risk in patients being prescribed dual antiplatelet therapy, physicians should consider bleeding risk, especially GI bleeding," Dr. Bhatt concluded. "In appropriate patients, the use of PPIs may reduce this risk."

"While the COGENT trial studied patients on aspirin plus clopidogrel, the results regarding the protective effect of PPIs likely apply to prasugrel and ticagrelor which are more potent than clopidogrel and would therefore be expected to have a higher risk of GI bleeding," he added.

Dr. Michael E. Farkouh from the University of Toronto, Canada, who wrote an editorial accompanying the report, told Reuters Health by email, "We need to consider a GI-protective strategy in all of our cardiac patients on low-dose aspirin."

"The COGENT investigators should be commended for bringing this important GI safety issue to the forefront because it has been long overshadowed by both the concern about a PPI-clopidogrel interaction and by the false sense of security in the belief that low-dose aspirin, as opposed to high-dose aspirin, does not warrant a GI-protective strategy," his writes in the editorial.

Dr. Marco Valgimigli from Bern University Hospital in Switzerland, who recently reviewed the safety of PPIs in patients receiving DAPT, told Reuters Health by email that "PPIs are an effective, cheap, and cost-effective way to minimize GI events in patients while on DAPT. PPI should probably be more liberally prescribed in such patents."

"The risk of GI events in patients taking aspirin or DAPT is probably not entirely appreciated by the community," Dr. Valgimigli said. "These events happen remotely from PCI or index hospitalization for ACS and they may be overlooked by cardiologists whose focus is more acute or periprocedural."


J Am Coll Cardiol 2016.

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