Pirenzepine in Duodenal Ulcer Relapse rates with a SOmg nightly dose are similar to those obtained with placebo . ..

In a multtcentre randomised double-blind study, 82 pattents of mean age 47 years, wtth healed duodenal ulcers, received pirenzepine 50mg (n = 41) or placebo (41) nightly for 12 months. Endoscopy was performed routinely at 6 and 12 months, and additionally if symptomatic review at 3 or 9 months tndtcated the presence of an ulcer.

12% of patients receiving placebo and 14% receiving ptrenzeptne were lost to follow-up. After 3 months, 28% of pirenzepine-treated and 19% of placebo-treated patients had symptomattc relapses which were then endoscopically confirmed. At the 6-month endoscopic follow-up, ulcer relapse had occurred in 50 and 57%, respectively, of the remaining patients, and after 1 year, the total relapse rate was 68% in patients on placeho and 65% in patients on pircnzepine. When relapse rate was considered with respect to the nature of medication used for the most recent ulcer (before the study), no significant difference was found between cimetidine- (65% relapse) and pirenzepine- (50%) treated patients. The authors concluded that ptrenzepine 50mg at ntght showed duodenal ulcer prophylactic efficacy not signtficantly different from placebo Bergemann W. Braun H. Buttner GR He1d1nger HP. Henke F. et at MediZ1n1sche Welt 38 6568. 15 Jan 1987

... and healing rates and symptom relief are similar with pirenzepine and cimetidine In a randomised double-blind study, 28 evaluable patients with endoscopically confirmed duodenal

ulcer received pirenzepine 1 OOmg or cimetidine 800mg, as single nocturnal doses, for 4 weeks. Endoscopy was performed one week after the end of treatment, and clinical assessment was made after 2 and 4 weeks of treatment.

No significant difference was found between ulcer healing rates for the 2 drugs. Patients receiving pirenzepine showed 87% ulcer healtng after 4 weeks of treatment (p < 0.01 vs baseline) vs 77% in patients receiving cimetidine (p < 0.01 ). Daytime epigastric pain was significantly improved after 4 weeks with pirenzepine, as compared with pain at 2 weeks, with 87% of patients experiencing complete relief of pain, while for cimetidine complete pain relief was obtained in 77% of patients after 4 weeks: this improvement was also significant. Patients reported no adverse effects. The authors concluded that the two drugs, administered once daily at night, were ' ... equally effective in the treatment of duodenal ulcer'. Perez JY Go ,JT L1m V Ang V Alvarez SZ et at Phil1ppme Journal of Internal Med1cme 24 271-278. NovDec 1986

12 INPHARMA · 2 May 1987 0156-2703j87j0502-0012j0$01 00/0 © ADIS Press