Document Detail


Comparative clinical trial of enprostil and ranitidine in the treatment of gastric ulcer.
MedLine Citation:
PMID:  3092661     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In a randomized, double-bind, parallel, multi-clinic study, the safety and efficacy of enprostil (35 micrograms twice daily) and ranitidine (150 mg twice daily) were compared in the treatment of active gastric ulcer in 93 outpatients (47 enprostil-treated patients and 46 ranitidine). The two treatment groups were well matched for demographic characteristics. The healing rates in the enprostil group were 22, 58, 80, and 86 percent at two, four, six, and eight weeks, respectively. The corresponding rates in the ranitidine group were 22, 66, 84, and 89 percent. None of these differences was statistically significant. The area of the ulcer at baseline and smoking status did not appear to influence healing rates. There were no significant differences between treatment groups in time to relief of ulcer symptoms, frequency of daytime or nighttime ulcer pain, or antacid use. Side effects attributable to enprostil treatment were diarrhea (10 percent versus 6 percent with ranitidine), gastrointestinal pain, and vomiting. These side effects, however, did not influence the patients' assessments of their overall response to enprostil and ranitidine therapy. Six enprostil-treated patients and one ranitidine-treated patient withdrew from the trial prematurely because of adverse experiences. Monitoring of clinical laboratory test results showed no significant changes in the two treatment groups. This study demonstrates that a prostaglandin E2 analogue, enprostil, in a dose of 35 micrograms twice daily, is similarly safe and effective as ranitidine in the treatment of active gastric ulcer.
Authors:
H G Dammann; W Hüttemann; H D Kalek; H G Rohner; B Simon
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The American journal of medicine     Volume:  81     ISSN:  0002-9343     ISO Abbreviation:  Am. J. Med.     Publication Date:  1986 Aug 
Date Detail:
Created Date:  1986-10-06     Completed Date:  1986-10-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0267200     Medline TA:  Am J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  80-4     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Antacids / administration & dosage
Clinical Trials as Topic
Double-Blind Method
Enprostil
Female
Humans
Male
Middle Aged
Prostaglandins E, Synthetic / administration & dosage,  adverse effects,  therapeutic use*
Random Allocation
Ranitidine / administration & dosage,  adverse effects,  therapeutic use*
Smoking
Stomach Ulcer / drug therapy*
Time Factors
Chemical
Reg. No./Substance:
0/Antacids; 0/Prostaglandins E, Synthetic; 66357-35-5/Ranitidine; 73121-56-9/Enprostil

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


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