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Omepmazole or high‐dose ranitidine in the treatment of patients with reflux oesophagitis not responding to ‘standard doses’of H 2 ‐receptor antagonists
Author(s) -
LUNDELL L.,
BACKMAN L.,
EKSTRÖM P.,
ENANDER L.H.,
FAUSA O.,
LIND T.,
LÖNROTH H.,
SANDMARK S.,
SANDZÉN B.,
UNGE P.,
WESTIN I. H.
Publication year - 1990
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.1990.tb00459.x
Subject(s) - ranitidine , omeprazole , medicine , cimetidine , gastroenterology , heartburn , basal (medicine) , reflux , esophagitis , randomized controlled trial , endoscopy , disease , insulin
SUMMARY Ninety‐eight patients (26 females), who presented with erosive and/or ulcerative oesophagitis, despite at least a 3‐month period of treatment with standard doses of cimetidine (≥ 1200 mg daily) or ranitidine (≥ 300 mg daily), were included in a double‐blind, randomized trial to compare omeprazole (40 mg o.m.) with a high dose of ranitidine (300 mg b.d.). The treatment was given for 4–12 weeks; endoscopy assessment and laboratory screening were performed on entry to the trial and thereafter every fourth week. Endoscopic healing was defined as complete epithelialization of all macroscopic erosions or ulcers in the squamous epithelium. An ‘intention‐to‐treat’analysis of the clinical datarevealed omeprazole to be superior to ranitidine : 63 % of those patients who were given omeprazole were heaIed endoscopically after a 4‐week period of treatment, compared with only 17 % of those given ranitidine. This difference in healing rate persisted during the 12‐week study period (90% DS 47% after 12 weeks; P < 0.0001). Reflux symptoms were more rapidly and completely relieved with omeprazole : heartburn resolved completely in 86% of patients treated with omeprazole for 4 weeks compared with 32% in the ranitidine group (P < 0.0001). The mean basal gastrin concentrations increased only in those given omeprazole from 18.9 pmol/L at pre‐entry to a mean value of 31.7 pmol/L on the last day of omeprazole administration. In ranitidine‐treated patients no significant increase in basal gastrin concentration was observed. Both drugs were well tolerated with few adverse events, which were mainly mild and transient. These results demonstrate the superiority of omeprazole over a high dose of ranitidine in the treatment of resistant reflux oesophagitis.