Clopidogrel plus omeprazole compared with aspirin plus omeprazole for aspirin-induced symptomatic peptic ulcers/erosions with low to moderate bleeding/re-bleeding risk — a single-blind, randomized controlled study

Authors


Dr F. -H. Ng, Department of Medicine, Ruttonjee Hospital, 266 Queen Road East, Wan Chai, Hong Kong SAR, China.
E-mail: ngfhong@ctimail3.com

Summary

Background : Clopidogrel causes significantly less symptomatic peptic ulcer disease and gastrointestinal bleeding than low-dose aspirin in average-risk patients. The gastrotoxicity of clopidogrel in patients with active peptic ulcer disease is unknown.

Aim : To compare the incidence of unhealed ulcers in patients receiving clopidogrel or aspirin.

Methods : Patients with aspirin-induced peptic ulcer disease treated with omeprazole (20 mg/day) were randomized to receive clopidogrel (75 mg/day) or to continue with low-dose aspirin. Success was defined as ulcer/erosion healing at the eighth week.

Results : One hundred and twenty-nine patients were recruited (69 received clopidogrel and 60 continued with aspirin). Thirty-one (45%) in the clopidogrel group and 25 (42%) in the aspirin group had a minor gastrointestinal bleed. No ulcer showed an adherent clot or visible vessel. The distributions of peptic ulcer disease were similar in the clopidogrel and aspirin groups (gastric ulcer: 41% vs. 40%; duodenal ulcer: 10% vs. 12%; gastric ulcer + duodenal ulcer: 6% vs. 3%; gastritis: 32% vs. 37%; duodenitis: 4% vs. 7%; gastritis + duodenitis: 0% vs. 2%). Clopidogrel and aspirin were re-started after 0.86 ± 1.79 and 0.44 ± 1.60 days, respectively (P = 0.170). Three (4%) patients stopped clopidogrel due to drug rash. Using per protocol analysis, the treatment success rates of clopidogrel and aspirin were 94% (62/66) and 95% (57/60), respectively.

Conclusions : In patients with aspirin-associated peptic ulcer disease of low to moderate grade, both early conversion from aspirin to clopidogrel and continuation of aspirin are safe.

Ancillary