Document Detail

Double-blind randomized trials of single-tablet ibuprofen/high-dose famotidine vs. ibuprofen alone for reduction of gastric and duodenal ulcers.
MedLine Citation:
PMID:  22186979     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: We performed two 24-week double-blind trials (REDUCE-1 and -2 (Registration Endoscopic Studies to Determine Ulcer Formation of HZT-501 Compared with Ibuprofen: Efficacy and Safety Studies)) to assess whether double-dose famotidine given in a single-tablet combination with ibuprofen (HZT-501) significantly reduces gastric and duodenal ulcers as compared with ibuprofen.
METHODS: Patients (40-80 years) requiring daily non-steroidal anti-inflammatory drugs (NSAIDs) for ≥6 months with no prior ulcer complications, negative H. pylori stool test, and baseline endoscopy showing no ulcers and <5 erosions were randomly assigned in a 2:1 ratio to HZT-501 or identical-appearing ibuprofen 800 mg tablets thrice daily. Study endoscopies were done at 8, 16, and 24 weeks. After unblinding and initial analyses, 12 patients were found to be misclassified as having gastric ulcers based on the adjudication of endoscopy reports, and analyses were re-run.
RESULTS: In REDUCE-1, the primary end point analysis of gastric ulcers at 24 weeks with HZT-501 vs. ibuprofen was 12.7% vs. 22.9% (P=0.0044) in the post-adjudication analysis. In REDUCE-2, the primary end point analysis of upper gastrointestinal (GI) ulcers was 13.0% vs. 20.5% (P=0.0587) in the post-adjudication analysis. Prespecified pooled analyses showed significantly fewer gastric (12.5% vs. 20.7%) and duodenal ulcers (1.1% vs. 5.1%) with HZT-501 vs. ibuprofen. Proportional hazards analysis of multiple potential risk factors showed the risk ratio of upper GI ulcers with HZT-501 vs. ibuprofen was 0.46, 95% confidence interval was 0.34-0.61.
CONCLUSIONS: Combined results of the REDUCE studies indicate that double-dose famotidine plus ibuprofen, given as a combination tablet, decreases endoscopic upper GI ulcers as compared with ibuprofen alone.
Loren Laine; Alan J Kivitz; Alfonso E Bello; Amy Y Grahn; Michael H Schiff; Ali S Taha
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-12-20
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  107     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-05     Completed Date:  2012-04-27     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  379-86     Citation Subset:  IM    
Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
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MeSH Terms
Administration, Oral
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage,  therapeutic use*
Anti-Ulcer Agents / administration & dosage,  therapeutic use*
Chi-Square Distribution
Double-Blind Method
Drug Combinations
Duodenal Ulcer / drug therapy*
Endoscopy, Gastrointestinal
Famotidine / administration & dosage,  therapeutic use*
Ibuprofen / administration & dosage,  therapeutic use*
Middle Aged
Proportional Hazards Models
Risk Factors
Stomach Ulcer / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 0/Drug Combinations; 15687-27-1/Ibuprofen; 76824-35-6/Famotidine
Comment In:
Evid Based Med. 2013 Feb;18(1):26-7   [PMID:  22773762 ]
Am J Gastroenterol. 2012 Mar;107(3):387-8   [PMID:  22388022 ]

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

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