Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin.
OBJECTIVE
Low-dose aspirin is standard treatment for prevention of cardiovascular events in at-risk patients. However, long-term administration of low-dose aspirin is associated with a greater risk of adverse events, including gastroduodenal ulcers. This study determined the efficacy of esomeprazole for reducing the risk of gastric and/or duodenal ulcers and dyspeptic symptoms in patients receiving continuous, low-dose aspirin therapy.


METHODS
Patients aged > or =60 yr, without baseline gastroduodenal ulcer at endoscopy, who were receiving aspirin 75-325 mg once daily, were randomized to esomeprazole 20 mg once daily or placebo for 26 wk. The presence of endoscopic gastric and/or duodenal ulcers and esophageal lesions was assessed at weeks 8 and 26. Upper gastrointestinal symptoms were assessed at weeks 8, 16, and 26.


RESULTS
The intention-to-treat population comprised 991 patients (esomeprazole, N = 493; placebo, N = 498). Twenty-seven patients (5.4%) in the placebo group developed a gastric or duodenal ulcer during 26 weeks' treatment compared with eight patients (1.6%) in the esomeprazole group (life-table estimates: 6.2%vs 1.8%; P= 0.0007). At 26 wk, the cumulative proportion of patients with erosive esophagitis was significantly lower for esomeprazole versus placebo (4.4% and 18.3%, respectively; P < 0.0001). At 26 wk, esomeprazole-treated patients were more likely to experience resolution of heartburn, acid regurgitation, and epigastric pain (P < 0.05).


CONCLUSIONS
Esomeprazole 20 mg once daily reduces the risk of developing gastric and/or duodenal ulcers and symptoms associated with the continuous use of low-dose aspirin in patients aged > or =60 yr without preexisting gastroduodenal ulcers.
Yeomans
Neville
N
School of Medicine, University of Western Sydney, Sydney, Australia.
Lanas
Angel
A
Labenz
Joachim
J
van Zanten
Sander Veldhuyzen
SV
van Rensburg
Christoffel
C
Rácz
Istvan
I
Tchernev
Konstantin
K
Karamanolis
Dimitrios
D
Roda
Enrico
E
Hawkey
Chris
C
Nauclér
Emma
E
Svedberg
Lars-Erik
LE
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D014943:Global Health; D006801:Humans; D015994:Incidence; D008297:Male; D010437:Peptic Ulcer / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004791:Enzyme Inhibitors; D064098:Esomeprazole; D001241:Aspirin