Document Detail


Misoprostol coadministered with diclofenac for prevention of gastroduodenal ulcers. A one-year study.
MedLine Citation:
PMID:  7729275     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objective of this study was to determine the long-term efficacy of misoprostol in preventing diclofenac-induced gastroduodenal ulcers in rheumatoid arthritis and osteoarthritis patients. Three hundred eighty-four patients who had an endoscopically confirmed gastric or duodenal lesion that had healed with misoprostol therapy were randomized to receive misoprostol or placebo coadministered with diclofenac for up to 52 weeks. Endoscopic examinations were repeated at weeks 12, 24, and 52. The development of a gastric and/or duodenal ulcer was considered a prophylaxis failure. Results in the evaluable cohort of patients demonstrated that gastroduodenal ulcer incidences were lower with misoprostol than placebo for all study periods (0-12 weeks, 7% vs 23%; 0-24 weeks, 11% vs 26%; and 0-52 weeks, 15% vs 31%). Misoprostol did not interfere with the antiarthritic effects of diclofenac. In conclusion, misoprostol coadministered with diclofenac for 12 months to patients with rheumatoid arthritis or osteoarthritis significantly reduced the incidence of diclofenac-induced gastroduodenal ulcers (P < or = 0.018).
Authors:
N M Agrawal; H E Van Kerckhove; L J Erhardt; G S Geis
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Digestive diseases and sciences     Volume:  40     ISSN:  0163-2116     ISO Abbreviation:  Dig. Dis. Sci.     Publication Date:  1995 May 
Date Detail:
Created Date:  1995-06-01     Completed Date:  1995-06-01     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7902782     Medline TA:  Dig Dis Sci     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1125-31     Citation Subset:  AIM; IM    
Affiliation:
Department of Gastroenterology, Ochsner Clinic, New Orleans, Louisiana 70121, USA.
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MeSH Terms
Descriptor/Qualifier:
Arthritis, Rheumatoid / drug therapy*
Diclofenac / administration & dosage,  adverse effects*,  therapeutic use*
Endoscopy, Gastrointestinal
Female
Humans
Incidence
Life Tables
Male
Middle Aged
Misoprostol / administration & dosage,  therapeutic use*
Osteoarthritis / drug therapy*
Peptic Ulcer / chemically induced,  epidemiology,  prevention & control*
Time Factors
Chemical
Reg. No./Substance:
15307-86-5/Diclofenac; 59122-46-2/Misoprostol

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


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