Placebo-controlled trial with the somatostatin analogue SMS 201-995 in peptic ulcer bleeding.

A 5-day, double-blind, placebo-controlled, multicenter trial in 23 centers with a total of 273 patients [241 evaluable patients; 126 on placebo and 115 on a long-acting somatostatin analogue (SMS 201-995, octreotide, Sandostatin)] resulted in no difference in stopping bleeding and preventing rebleeding between placebo (70.6%) and SMS 201-995 (69.6%). Surgery rates, blood transfusion requirements, and time required before bleeding stopped were also not significantly different between the two groups. A retrospective subgroup analysis according to age, sex, localization of the ulcers, severity of the bleeding, and arterial spurting vs. oozing showed homogeneity and did not allow identification of a subgroup that might benefit from treatment with SMS 201-995. The tolerability of SMS 201-995 was very good. No difference was found between placebo and SMS 201-995 with regard to the side-effect profile.

RCT Entities:   Population Interventions Outcomes