Ranitidine for Gastric and Duodenal Ulceration Patients with gastric ulcer fare better on ranitidine than placebo ...

In a double-blind multicentre study, 206 benign gastric ulcer patients from 16 centres were randomly assigned to receive either placebo or ranitidine 150mg bid for 6 weeks. At the conclusion of the study ranitidine patients showed significantly higher healing rates than placebo (68% vs 53% respectively). Among patients unhealed after 6 weeks, those on ranitidine were significantly more free of pain than placebo-treated patients (43% pain-free with ranitidine vs 18% with placebo), and ranitidine-treated patients consumed significantly fewer antacid tablets than placebo recipients (0.3 tablets/day with ranitidine vs 2.3 tablets/day with placebo).

During the study, the incidence of antacid consumption was reduced in ranitidine-treated patients and in healed placebo recipients, but patients taking antacids increased from 78% to 89% in placebo non-healing patients. The authors concluded that • ... ranitldine 150mg administered twice dally for 6 weeks was well tolerated and significantly accelerated healing of gastric ulcers compared with placebo'. Hirschowitz 81, DeLuca V. Graham D. Lorber S. Bright-Asare P. eta/. Journal of Clmtcal Gastroenlerology 8: 371-376. Jun 1986

... and in a large trial 150mg twice daily appears to heal even refractory DU In a randomised double-blind study, 382 patients with endoscopically confirmed duodenal ulcers from 19

centres were assigned to treatment with ranitidine (n = 187) 150mg twice daily or placebo (n = 168) for 4 weeks (phase 1). Patients with unhealed ulcers were re-randomised to ranitidine (n = 57) or placebo (n = 67) treatment (phase 2).

In phase 1, after 2 and 4 weeks of treatment, 37 and 73% of patients, respectively, on ranitidine hc..j healed ulcers vs 19 and 45%, respectively, on placebo (p < 0.01 ). In phase 2. 64% on ranitidine vs 40% on placebo had ulcers healed after 4 weeks (p < 0.05). The presence of unhealed ulcer was associated with persistence of pain. The number of patients who experienced relief of daytime pain after 2 and 4 weeks in phase 1 (p < 0.05 and p < 0.01 respectively) and after 4 weeks in phase 2 (p < 0.01) was significantly greater in the ranitidine group than in the placebo group. Night-time pain resolved after 4 weeks of treatment in 57% on ranitidine vs 36% on placebo in phase 1 (p < 0.01) and in 70% on ranitidine vs 45% on placebo in phase 2 (p < O.D1 ). Antacid consumption was significantly less in the ranitidine group vs the placebo group.

Side effects included headache (5% on ranitidine vs 4% on placebo), abdominal pain (2% on ranitidine vs 3% on placebo) and vomiting (2% on placebo). One patient developed hepatitis (presumed to be non-A, non-B) and was thought to be due to a blood transfusion given 6 months earlier.

The auihots co;;cluded that mr:itidine was •more effective than placebo after both 2 and 4 weeks of treatment' in patients with duodenal ulcers. Hirschowitz 81. Berenson MM. Benkowitz JM. Bright-Asare P. DeLuca VA. eta/. Journal of Cllmcal Gastroenterology 8: 359-366. Jun 1986

12 INPHARMA«> 8 Nov 1986 0156-2703j86j1108.0012j0$01.00/0 © ADIS Press