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Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy.
- Source :
-
Journal of the American College of Cardiology [J Am Coll Cardiol] 2016 Apr 12; Vol. 67 (14), pp. 1661-71. Date of Electronic Publication: 2016 Mar 21. - Publication Year :
- 2016
-
Abstract
- Background: The COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) showed that proton-pump inhibitors (PPIs) safely reduced rates of gastrointestinal (GI) events in patients requiring dual antiplatelet therapy (DAPT). However, utilization of appropriate prophylactic PPI therapy remains suboptimal, especially with low-dose aspirin.<br />Objectives: The authors investigated the safety and efficacy of PPI therapy in patients receiving DAPT in low- and high-dose aspirin subsets.<br />Methods: Randomized patients with available aspirin dosing information in COGENT (N = 3,752) were divided into "low-dose" (≤ 100 mg) and "high-dose" (>100 mg) aspirin groups. The primary GI and cardiovascular endpoints were composite upper GI events and major adverse cardiac events, respectively. All events were adjudicated by independent, blinded gastroenterologists and cardiologists.<br />Results: Median duration of follow-up was 110 days. Low-dose aspirin users (n = 2,480; 66.1%) were more likely to be older, female, and have higher rates of peripheral artery disease, prior stroke, and hypertension, whereas high-dose aspirin users (n = 1,272; 33.9%) had higher rates of hyperlipidemia, smoking, a history of percutaneous coronary intervention, and were more than twice as likely to be enrolled from sites within the United States (80.4% vs. 39.8%). High-dose aspirin was associated with similar 180-day Kaplan-Meier estimates of adjudicated composite GI events (1.7% vs. 2.1%; adjusted hazard ratio: 0.88; 95% confidence interval: 0.46 to 1.66) and major adverse cardiac events (4.8% vs. 5.5%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.48 to 1.11) compared with low-dose aspirin. Randomization to PPI therapy reduced 180-day Kaplan-Meier estimates of the primary GI endpoint in low-dose (1.2% vs. 3.1%) and high-dose aspirin subsets (0.9% vs. 2.6%; p for interaction = 0.80), and did not adversely affect the primary cardiovascular endpoint in either group.<br />Conclusions: Gastroprotection with PPI therapy should be utilized in appropriately selected patients with coronary artery disease requiring DAPT, even if the patients are on low-dose aspirin. (Clopidogrel and the Optimization of Gastrointestinal Events Trial [COGENT]; NCT00557921).<br /> (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Aspirin adverse effects
Clopidogrel
Dose-Response Relationship, Drug
Drug Therapy, Combination
Dyspepsia chemically induced
Dyspepsia prevention & control
Female
Gastrointestinal Hemorrhage chemically induced
Gastrointestinal Hemorrhage prevention & control
Humans
Intestinal Obstruction chemically induced
Intestinal Obstruction prevention & control
Intestinal Perforation chemically induced
Intestinal Perforation prevention & control
Male
Middle Aged
Myocardial Infarction epidemiology
Myocardial Revascularization statistics & numerical data
Pain chemically induced
Pain prevention & control
Peptic Ulcer chemically induced
Peptic Ulcer prevention & control
Platelet Aggregation Inhibitors adverse effects
Prospective Studies
Stroke epidemiology
Ticlopidine administration & dosage
Ticlopidine adverse effects
Aspirin administration & dosage
Omeprazole therapeutic use
Platelet Aggregation Inhibitors administration & dosage
Proton Pump Inhibitors therapeutic use
Ticlopidine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1558-3597
- Volume :
- 67
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- Journal of the American College of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 27012778
- Full Text :
- https://doi.org/10.1016/j.jacc.2015.12.068