Document Detail

A controlled study of ranitidine for the prevention of recurrent hemorrhage from duodenal ulcer.
MedLine Citation:
PMID:  8284002     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Hemorrhage is the most common complication of duodenal ulcer disease, but there is little information about the effectiveness and safety of long-term maintenance therapy with histamine H2-receptor blockers. METHODS: We conducted a double-blind study in patients with endoscopically documented hemorrhage from duodenal ulcers. Patients were randomly assigned to maintenance therapy with ranitidine (150 mg at night) or placebo and were followed for up to three years. Endoscopy was performed at base line (to document that the ulcers had healed), at exit from the study, and when a patient had persistent ulcer symptoms unrelieved by antacids or had gastrointestinal bleeding. Symptomatic relapses without bleeding were treated with ranitidine; if the ulcer healed within eight weeks, the patient resumed taking the assigned study medication. RESULTS: The two groups were similar at entry, which usually occurred about three months after the index hemorrhage. After a mean follow-up of 61 weeks, 3 of the 32 patients treated with ranitidine had recurrent hemorrhage, as compared with 12 of the 33 given placebo (P < 0.05). Half the episodes of recurrent bleeding were asymptomatic. One patient in the ranitidine group withdrew from the study because of asymptomatic thrombocytopenia during the first month. CONCLUSIONS: For patients whose duodenal ulcers heal after severe hemorrhage, long-term maintenance therapy with ranitidine is safe and reduces the risk of recurrent bleeding.
D M Jensen; S Cheng; T O Kovacs; G Randall; M E Jensen; T Reedy; H Frankl; G Machicado; J Smith; M Silpa
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The New England journal of medicine     Volume:  330     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1994 Feb 
Date Detail:
Created Date:  1994-02-17     Completed Date:  1994-02-17     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  382-6     Citation Subset:  AIM; IM    
Center for Ulcer Research and Education, UCLA.
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MeSH Terms
Double-Blind Method
Duodenal Ulcer / complications*
Middle Aged
Peptic Ulcer Hemorrhage / etiology,  prevention & control*
Ranitidine / adverse effects,  therapeutic use*
Grant Support
Reg. No./Substance:
Comment In:
N Engl J Med. 1994 Feb 10;330(6):428-9   [PMID:  8284010 ]
N Engl J Med. 1994 Jul 7;331(1):53; author reply 53-4   [PMID:  8202110 ]

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

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