Document Detail

Esomeprazole alone compared with esomeprazole plus aspirin for the treatment of aspirin-related peptic ulcers.
MedLine Citation:
PMID:  22508148     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Aspirin-related peptic ulcers are a common disorder. However, whether or not aspirin should be continued during treatment for aspirin-related ulcers remains unclear.
AIMS: To compare esomeprazole alone with esomeprazole plus aspirin in the treatment of aspirin-related peptic ulcers and to investigate the independent factors associated with the failure of ulcer healing.
METHODS: From January 2008 to July 2011, patients with aspirin-related peptic ulcers were randomized to receive esomeprazole (40 mg per day) alone or esomeprazole (40 mg per day) plus aspirin (100 mg per day) for 8 weeks. The subjects with Helicobacter pylori infection were treated with standard triple therapy. Follow-up endoscopy was carried out at the end of the 8th week. The primary end point was the healing of peptic ulcers.
RESULTS: In all, 178 patients (89 receiving esomeprazole alone and 89 receiving esomeprazole plus aspirin) were enrolled and underwent follow-up endoscopy. The healing rate of ulcers by modified intention-to-treat analysis was 82.5% (95% confidence interval (CI), 74.2-90.8%) among patients treated with esomeprazole alone and 81.5% (95% CI, 73.0-90.0%) among patients treated with esomeprazole plus aspirin (difference, 1.0%; 95% CI, -11.2 to 12.6%). The per-protocol analysis yielded similar results (healing rate: 83.1% vs. 83.8%, respectively; difference, 0.7%; 95% CI, -11.2 to 12.6%). Multivariate analysis disclosed that use of steroids during treatment (odds ratio: 5.6; 95% CI, 1.1-27.7%) was the only independent factor associated with the failure of ulcer healing.
CONCLUSIONS: The observed ulcer healing rates were comparable in the esomeprazole and esomeprazole-plus-aspirin groups, but the wide CIs do not rule out clinically meaningful differences of more than 10%.
Chun-Peng Liu; Wen-Chi Chen; Kwok-Hung Lai; Guang-Yuan Mar; Shyr-Yi Lin; Luo-Ping Ger; Ping-I Hsu;
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-04-17
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  107     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-05     Completed Date:  2012-10-24     Revised Date:  2013-01-07    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1022-9     Citation Subset:  IM    
Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan, ROC.
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MeSH Terms
Anti-Ulcer Agents / administration & dosage,  adverse effects*
Aspirin / administration & dosage,  adverse effects,  therapeutic use*
Cardiovascular Diseases / prevention & control
Chi-Square Distribution
Drug Therapy, Combination
Esomeprazole Sodium / administration & dosage,  therapeutic use*
Helicobacter Infections / diagnosis
Helicobacter pylori
Peptic Ulcer / chemically induced*,  drug therapy*
Platelet Aggregation Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
Risk Factors
Treatment Outcome
Reg. No./Substance:
0/Anti-Ulcer Agents; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; L2C9GWQ43H/Esomeprazole Sodium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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