ON-DEMAND TREATMENT OF GASTROESOPHAGEAL REFLUX SYMPTOMS - A COMPARISON OF RANITIDINE 75 MG WITH CIMETIDINE 200 MG OR PLACEBO

Citation
Jp. Galmiche et al., ON-DEMAND TREATMENT OF GASTROESOPHAGEAL REFLUX SYMPTOMS - A COMPARISON OF RANITIDINE 75 MG WITH CIMETIDINE 200 MG OR PLACEBO, Alimentary pharmacology & therapeutics, 12(9), 1998, pp. 909-917
Citations number
23
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology & Pharmacy","Gastroenterology & Hepatology
ISSN journal
0269-2813
Volume
12
Issue
9
Year of publication
1998
Pages
909 - 917
Database
ISI
SICI code
0269-2813(1998)12:9<909:OTOGRS>2.0.ZU;2-Q
Abstract
Aim: To compare the effects of ranitidine 75 mg with those of either c imetidine 200 mg or placebo given on demand for relief of typical symp toms of gastro-oesophageal reflux disease during a 15-day period. Meth ods: A total of 1336 patients (aged greater than or equal to 18 years) with heartburn episodes were recruited and randomly assigned to a ran itidine 75 mg, cimetidine 200 mg or placebo group, Depending on the oc currence or persistence of heartburn, treatment was administered as re quired up to three times daily, with at least 2 h between drug doses. Antacids were allowed as rescue medication if symptoms persisted for a t least 2 h after the third medication on any given day. The primary e nd-point was defined as the proportion of patients with relief of at l east 75% of heartburn episodes during the study period (i.e. relief oc curring within 2 h after drug ingestion and lasting for at least 5 h), Results: Analysis was performed in an intention-to-treat population c omprising 504 subjects in the ranitidine group, 515 in the cimetidine group and 270 in the placebo group. Primary end-point success rates we re 41, 38 and 28%, respectively, for the three groups (P < 0.001 for r anitidine vs, placebo, P = 0.274 for ranitidine vs. cimetidine). Ranit idine 75 mg was significantly more effective than placebo in providing overall heartburn relief (P < 0.001). The differences between the ran itidine and cimetidine groups were not significant, except for a great er reduction in heartburn frequency in the ranitidine group at the end of the study period (P < 0.05). Drug dose was lower and less rescue m edication was used in the ranitidine group than the placebo group. The three treatment groups did not differ in terms of tolerability. Concl usion: On-demand ranitidine 75 mg or cimetidine 200 mg are safe and ef fective treatment for reflux-related symptoms.