Efficacy and Safety of Proton-Pump Inhibitors in High-Risk Cardiovascular Subsets of the COGENT Trial.

Autor:	Vaduganathan M; Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass., Cannon CP; Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass; Harvard Clinical Research Institute, Boston, Mass., Cryer BL; University of Texas Southwestern and Veterans Affairs North Texas Health Care System, Dallas., Liu Y; Harvard Clinical Research Institute, Boston, Mass; Department of Biostatistics, Boston University, Mass., Hsieh WH; Harvard Clinical Research Institute, Boston, Mass., Doros G; Harvard Clinical Research Institute, Boston, Mass; Department of Biostatistics, Boston University, Mass., Cohen M; Newark Beth Israel Medical Center, NJ., Lanas A; University of Zaragoza, Instituto de Investigación Sanitaria Aragón, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Zaragoza, Spain., Schnitzer TJ; Departments of Physical Medicine and Rehabilitation and Internal Medicine-Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, Ill., Shook TL; PAREXEL International, Waltham, Mass., Lapuerta P; Lexicon Pharmaceuticals, Basking Ridge, NJ., Goldsmith MA; Constellation Pharmaceuticals, Cambridge, Mass., Laine L; Yale School of Medicine, New Haven, Conn; VA Connecticut Healthcare System, West Haven, Conn., Bhatt DL; Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Mass. Electronic address: dlbhattmd@post.harvard.edu.
Jazyk:	angličtina
Zdroj:	The American journal of medicine [Am J Med] 2016 Sep; Vol. 129 (9), pp. 1002-5. Date of Electronic Publication: 2016 Apr 30.
DOI:	10.1016/j.amjmed.2016.03.042
Abstrakt:	Background: Proton-pump inhibitors (PPIs) have been demonstrated to reduce rates of gastrointestinal events in patients requiring dual antiplatelet therapy (DAPT). Data are limited regarding the efficacy and safety of PPIs in high-risk cardiovascular subsets after acute coronary syndrome or percutaneous coronary intervention. Methods: All patients enrolled in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) were initiated on DAPT (with aspirin and clopidogrel) for various indications within the prior 21 days. These post hoc analyses of the COGENT trial evaluated the efficacy and safety of omeprazole compared with placebo in subsets of patients requiring DAPT for the 2 most frequent indications: 1) patients undergoing percutaneous coronary intervention (for any indication) within 14 days of randomization (n = 2676; 71.2%); and 2) patients presenting with acute coronary syndrome managed with or without percutaneous coronary intervention (n = 1573; 41.8%). Unadjusted Cox proportional hazards models were used to estimate effect sizes through final follow-up. Results: Median follow-up duration was 110 days (interquartile range 55-167). In percutaneous coronary intervention-treated patients, omeprazole significantly reduced rates of composite gastrointestinal events at 180 days (1.2% vs 2.7%; hazard ratio [HR] 0.43; 95% confidence interval [CI], 0.22-0.85; P = .02) without increasing composite cardiovascular events (5.4% vs 6.3%; HR 1.00; 95% CI, 0.67-1.50; P = 1.00). Similarly, omeprazole lowered risk of the primary gastrointestinal endpoint at 180 days in patients presenting with acute coronary syndrome (1.1% vs 2.7%; HR 0.37; 95% CI, 0.13-1.01; P = .05) without a significant excess in cardiovascular events (5.6% vs 4.5%; HR 1.40; 95% CI, 0.77-2.53; P = .27). Conclusions: PPI therapy attenuates gastrointestinal bleeding risk without significant excess in major cardiovascular events in high-risk cardiovascular subsets, regardless of indication for DAPT. Future studies will be needed to clarify optimal gastroprotective strategies for higher-intensity and longer durations of DAPT. (Copyright © 2016 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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