Prevalence and prediction of gastrointestinal events in patients receiving a combination of aspirin plus clopidogrel

Abstract

Introduction: The efficacy of the addition of clopidogrel to aspirin has been established but this was associated with gastrointestinal complications in 1.3% of patients in study situation. However, this has not been documented in real life. Aim: This retrospective study aimed to determine the prevalence of upper gastrointestinal complication in real life situation. The treatment effect of H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) was also analysed, as compared to the control. Method: From Jan 2002 to Sept 2005, records of all patients receiving dual anti-platelet therapy were analysed. The end-point was the occurrence of symptomatic peptic ulcers or its complications. The last date of censor was 15 June 2006. Results: The patient group consisted of 664 patients (age 66.6±12.0 years). Prophylactic H2RA and PPI was prescribed to 148 (22.2%) and 160(24.1%) patients, respectively. Prior gastrointestinal bleeding was significantly more common in the PPI group (16.3%) or the H2RA group (4.1%) than the control group (2.0%). After a follow-up of 4.6±5.2 months, end-point was reached in 28 (4.2%) patients (gastrointestinal bleed 26, dyspepsia 2). After adjustment for the confounding covariates, the hazard ratio (95% confidence interval) for primary end-point was 0.053 (0.006-0.219) for PPI and 0.324 (0.113- 0.925) for H2RA, as compared to control. Conclusion: In real life, the incidence of peptic ulcer disease and gastrointestinal bleeding associated with dual aspirin plus clopdiogrel therapy was 4.2%. Co-prescription with PPI or H2RA can significantly reduce the risk. Hazard ratio (95% confidence interval) for primary and secondary end points : control, H2- receptor antagonist and proton pump inhibitor.