The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial

Summary Background Dual anti‐platelet therapy with clopidogrel and low‐dose aspirin increases the risk for gastrointestinal clinical events. Omeprazole has been shown to significantly reduce these events without compromising cardiovascular safety in patients treated with dual anti‐platelet therapy. Whether or not omeprazole improves patient‐reported outcomes is undetermined. Aim To assess the impact of prophylactic omeprazole with background dual anti‐platelet therapy on patient‐reported symptoms of dyspepsia compared to placebo. Methods We analysed results of the Severity of Dyspepsia Assessment questionnaires collected in the Clopidogrel and the Optimization of Gastrointestinal Events Trial. Results Patient‐reported outcome data from 3759 subjects were available for analysis. At 4 weeks, the mean scores of pain intensity and nonpain symptoms were lower in the omeprazole group (5.61 ± 0.17 vs. 6.40 ± 0.17, P = 0.001, and 10.61 ± 0.07 vs. 11.00 ± 0.07, P