COGENT
Trial question
What is the role of prophylactic omeprazole among patients with an indication for dual antiplatelet therapy (aspirin and clopidogrel)?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 3759
3759 patients (1196 female, 2563 male).
Inclusion criteria: patients with an indication for dual antiplatelet therapy.
Key exclusion criteria: short-term or long-term use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; preexisting erosive esophagitis or esophageal or gastric variceal disease or previous nonendoscopic gastric surgery; receipt of clopidogrel or another thienopyridine for > 21 days before randomization; or recent fibrinolytic therapy.
Interventions
N=1876 omeprazole (omeprazole 20 mg plus clopidogrel 75 mg and aspirin 75-325 mg daily).
N=1883 placebo (clopidogrel 75 mg and aspirin 75-325 mg daily).
Primary outcome
Overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation
1.1%
2.9%
2.9 %
2.2 %
1.4 %
0.7 %
0.0 %
Omeprazole
Placebo
Significant
decrease ▼
NNT = 55
Significant decrease in overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation (1.1% vs. 2.9%; HR 0.34, 95% CI 0.18 to 0.63).
Secondary outcomes
Significant decrease in overt upper gastrointestinal bleeding (0.2% vs. 1.2%; HR 0.13, 95% CI 0.03 to 0.56).
No significant difference in cardiovascular event (4.9% vs. 5.7%; HR 0.99, 99% CI 0.68 to 1.44).
Safety outcomes
No significant differences in rate of serious adverse events (10.1% vs. 9.4%, p=0.48) and overall adverse events (41.3% vs. 42.8%, p=0.33).
Significant differences in risk of diarrhea (3.0% vs. 1.8%, p = 0.01).
Conclusion
In patients with an indication for dual antiplatelet therapy, omeprazole was superior to placebo with respect to overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation.
Reference
Bhatt DL, Cryer BL, Contant CF et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17.
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