Document Detail

Nizatidine prevents peptic ulceration in high-risk patients taking nonsteroidal anti-inflammatory drugs.
MedLine Citation:
PMID:  8215749     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Nonsteroidal anti-inflammatory drug (NSAID) use is increasingly recognized as a major factor associated with peptic ulcer disease and complications. We undertook a multicenter, double-blind, placebo-controlled trial to evaluate efficacy and safety of nizatidine in preventing ulcer formation in patients with osteoarthritis who were taking NSAIDs. METHODS: After endoscopy to rule out the presence of an acute ulcer, 496 patients were randomized to receive nizatidine, 150 mg twice daily (248 patients) or placebo (248 patients) for 3 months. Repeated endoscopies were performed monthly. We defined failure as development of a peptic ulcer (> or = 0.3 cm in diameter). RESULTS: Baseline characteristics tested were comparable for the two groups with regard to age, sex, ulcer history, and Helicobacter pylori status. Overall ulcer occurrence in the nizatidine group (9.7%) was not significantly different from that in the placebo group (13.7%; P = .163). High-risk subgroups (patients with ulcer history and patients > or = 65 years of age), however, revealed statistically fewer ulcers for patients receiving nizatidine (P = .035 and P = .042, respectively). Analysis of antacid use showed significantly less use in nizatidine recipients, although there were similar percentages of patients showing improvement in dyspeptic symptoms in each treatment group. We failed to observe a conclusive correlation between H pylori status at baseline, as measured by serum immunoglobulin antibody, and development of an ulcer. CONCLUSIONS: This study showed that nizatidine, 150 mg, twice daily, significantly reduces the incidence of ulcer formation in high-risk patients taking long-term NSAID therapy. It also relieves NSAID-associated dyspeptic symptoms in some patients.
L R Levine; M L Cloud; N H Enas
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Archives of internal medicine     Volume:  153     ISSN:  0003-9926     ISO Abbreviation:  Arch. Intern. Med.     Publication Date:  1993 Nov 
Date Detail:
Created Date:  1993-11-19     Completed Date:  1993-11-19     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0372440     Medline TA:  Arch Intern Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  2449-54     Citation Subset:  AIM; IM    
Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, Ind.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Double-Blind Method
Endoscopy, Digestive System
Middle Aged
Nizatidine / adverse effects,  therapeutic use*
Osteoarthritis / drug therapy
Peptic Ulcer / chemically induced,  diagnosis,  prevention & control*
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 76963-41-2/Nizatidine
Comment In:
Arch Intern Med. 1993 Nov 8;153(21):2411-2   [PMID:  8215746 ]

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