Document Detail

Nizatidine in therapy and prevention of non-steroidal anti-inflammatory drug-induced gastroduodenal ulcer in rheumatic patients.
MedLine Citation:
PMID:  7863248     Owner:  NLM     Status:  MEDLINE    
Two hundred and sixty-nine patients with various rheumatic disorders who had been treated with non-steroidal anti-inflammatory drugs (NSAID) for at least 3 weeks were enrolled in this randomized double-blind multicentre trial. Entry criteria were the presence of an ulcer in the gastric and/or duodenal mucosa (> 3 mm and < 20 mm in diameter) and dyspeptic symptoms. The patients were treated with 150 mg nizatidine nocte (n = 86), 2 x 150 mg/d (n = 93) and 2 x 300 mg/d (n = 90) nizatidine. All patients continued to take their original NSAID medication. The three nizatidine groups were well matched with respect to important patient characteristics. After 8 weeks of treatment more than 90% of gastric and duodenal ulcers (DU) had healed under all three nizatidine dosages. There was a tendency to higher healing rates in the case of gastric ulcers after 4 weeks following the higher dose of nizatidine. Erosion, in the stomach and duodenum as well as oesophagitis, improved to a similar degree with all nizatidine doses. There were similar improvements in clinical symptoms such as epigastric pain, heartburn etc. Consumption of additional antacids were similar in all three groups. In the subsequent prevention trial, 237/221 patients were followed for 3/6 months. In addition to their continued antirheumatic medication 116/107 received nizatidine 150 mg nocte and 121/114 patients 2 x 150 mg nizatidine daily. The cumulative relapse rates within 6 months averaged 5.5% in the low and 1.8% in the high dose group (NS). The safety of nizatidine was assessed as good in both the therapeutic and the preventive trial.(ABSTRACT TRUNCATED AT 250 WORDS)
B Simon; P Müller
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Scandinavian journal of gastroenterology. Supplement     Volume:  206     ISSN:  0085-5928     ISO Abbreviation:  Scand. J. Gastroenterol. Suppl.     Publication Date:  1994  
Date Detail:
Created Date:  1995-03-23     Completed Date:  1995-03-23     Revised Date:  2008-02-13    
Medline Journal Info:
Nlm Unique ID:  0437034     Medline TA:  Scand J Gastroenterol Suppl     Country:  NORWAY    
Other Details:
Languages:  eng     Pagination:  25-8     Citation Subset:  IM    
Krankenhaus Schwetzingen, Schwetzingen, Germany.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*,  therapeutic use
Double-Blind Method
Dyspepsia / drug therapy,  etiology
Middle Aged
Nizatidine / therapeutic use*
Peptic Ulcer / chemically induced*,  complications,  drug therapy*,  prevention & control
Rheumatic Diseases / complications,  drug therapy
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 76963-41-2/Nizatidine

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

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