Document Detail

Efficacy and tolerability of pantoprazole compared with misoprostol for the prevention of NSAID-related gastrointestinal lesions and symptoms in rheumatic patients.
MedLine Citation:
PMID:  14707396     Owner:  NLM     Status:  MEDLINE    
AIM: To compare the efficacy and tolerability of pantoprazole 20 mg once daily (o.d.) with misoprostol 200 microg twice daily (b.i.d.), administered for 6 months to rheumatic patients who required long-term therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and who were at increased risk of developing gastrointestinal lesions.
METHODS: This randomized, double-blind, multicenter, parallel group comparison study was performed with rheumatic patients (n = 515) who were likely to take NSAIDs continuously for at least 6 months. Patients were 55 years or older, at risk to develop gastrointestinal lesions, had less than five erosions/petechiae in the stomach and duodenum, no ulcers, no reflux esophagitis (endoscopy-proven), and gastrointestinal symptoms of at most moderate intensity. A minimum daily dose was defined for NSAIDs (COX-2 inhibitors were not available at the time). Patients were randomized to take either pantoprazole 20 mg o.d. (n = 257) or misoprostol 200 microg b.i.d. (n = 258) for 6 months while continuing NSAID therapy. Endoscopy was performed at baseline, 3, and 6 months.
RESULTS: Pantoprazole was superior to misoprostol (p < 0.001) with regard to 'therapeutic failure' (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, reflux esophagitis, severe gastrointestinal symptoms, and/or 'likely' or 'definitely' related adverse event leading to study termination). Estimated remission rates at 3 and 6 months (Kaplan-Meier life-table analysis) were, respectively, 93 and 89% (pantoprazole) and 79 and 70% (misoprostol). Pantoprazole was superior to misoprostol (p = 0.005) with regard to 'endoscopic failure' (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, or reflux esophagitis) after 6 months. Estimated remission rates at 3 and 6 months were, respectively, 98 and 95% (pantoprazole) and 95 and 86% (misoprostol). Patients discontinuing the study early due to adverse events 'likely' or 'definitely' related to the study drug accounted for 13/257 (5%) in the pantoprazole and 33/258 (13%) in the misoprostol treatment groups.
CONCLUSION: Pantoprazole 20 mg o.d. is superior to misoprostol 200 microg b.i.d. in the prevention of NSAID-induced gastrointestinal lesions and symptoms in patients on continuous long-term treatment with NSAIDs due to rheumatic diseases and at risk to develop such lesions or symptoms.
T Stupnicki; K Dietrich; P González-Carro; A Straszak; A Terjung; K B Thomas; R Lühmann; R Fischer
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2003-12-30
Journal Detail:
Title:  Digestion     Volume:  68     ISSN:  0012-2823     ISO Abbreviation:  Digestion     Publication Date:  2003  
Date Detail:
Created Date:  2004-02-20     Completed Date:  2004-05-27     Revised Date:  2013-06-04    
Medline Journal Info:
Nlm Unique ID:  0150472     Medline TA:  Digestion     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  198-208     Citation Subset:  IM    
Copyright Information:
Copyright 2003 S. Karger AG, Basel
General Hospital Graz-West, Department of Gastroenterology, Graz, Austria.
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MeSH Terms
Administration, Oral
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Anti-Ulcer Agents / adverse effects*,  pharmacology*,  therapeutic use
Benzimidazoles / adverse effects*,  pharmacology*,  therapeutic use
Double-Blind Method
Drug Administration Schedule
Gastrointestinal Diseases / chemically induced*,  prevention & control*
Middle Aged
Misoprostol / adverse effects*,  pharmacology*,  therapeutic use
Omeprazole / analogs & derivatives
Rheumatic Diseases / drug therapy*
Risk Factors
Sulfoxides / adverse effects*,  pharmacology*,  therapeutic use
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 0/Benzimidazoles; 0/Sulfoxides; 59122-46-2/Misoprostol; 73590-58-6/Omeprazole; D8TST4O562/pantoprazole

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

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