TITLE

2010 - Adding omeprazole to clopidogrel reduced GI events and did not increase CV events

AUTHOR(S)
Chow, Clara K.
PUB. DATE
March 2011
SOURCE
ACP Journal Club;3/20/2011, Vol. 154 Issue 3, p6
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Question In patients with coronary artery disease, what are the efficacy and safety of clopidogrel and omeprazole compared with clopidogrel alone? Methods Design Randomized placebo-controlled trial (Clopidogrel and the Optimization of Gastrointestinal Events Trial [COGENT]). ClinicalTrials.gov NCT00557921. Allocation Concealed. Blinding Blinded (patients, clinicians, cardiovascular event adjudication committee, {data collectors, data analysts, and manuscript writers}†).[#] Follow-up period Median 106 days. Setting 393 sites in 15 countries. Patients 3873 patients >21 years of age (median age 69 y, 68% men, 72% had percutaneous coronary intervention, 42% had acute coronary syndrome based on 3761 patients) for whom use of clopidogrel with aspirin was anticipated for >12 months. Exclusion criteria were hospitalization with anticipated discharge after 48 hours; need for a proton-pump inhibitor (PPI), H[sub 2]-receptor antagonist, sucralfate, or misoprostol; erosive esophagitis or esophageal or gastric variceal disease or previous nonendoscopic gastric surgery; use of clopidogrel or another thienopyridine for é>21 days before randomization; oral anticoagulation that could not be discontinued during study; and recent fibrinolytic therapy. Intervention Clopidogrel, 75 mg, plus omeprazole, 20 mg (CGT-2168; n =>1938), or clopidogrel, 75 mg, alone (n =>1935). Outcomes A composite of upper gastrointestinal (GI) clinical events (overt gastroduodenal bleeding; overt upper GI bleeding of unknown origin; bleeding of presumed occult GI origin with documented decrease in hemoglobin >2 g/dL or decrease in hematocrit >10%; symptomatic uncomplicated gastroduodenal ulcer; and persistent pain of presumed GI origin for >3 days and obstruction, perforation, or >5 gastroduodenal erosions). Primary cardiovascular (CV) safety outcome was a composite of death from CV causes, nonfatal myocardial infarction, coronary revascularization, or ischemic stroke. Patient follow-up 97% included in analyses; 95% completed the study. Main results The trial was discontinued early because the sponsor lost financing. At 180 days, omeprazole plus clopidogrel reduced risk for the composite GI endpoint (Table). Groups did not differ for the composite CV endpoint (Table) or for adverse events (P =>0.33) or serious adverse events (P =>0.48). Conclusion In patients with coronary artery disease, clopidogrel plus omeprazole reduced gastrointestinal events and did not increase cardiovascular events compared with clopidogrel alone.
ACCESSION #
78325711

 

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