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.
Christiansen
J
J
Department of Surgery, Glostrup Hospital, Copenhagen, Denmark.
Ottenjann
R
R
Von Arx
F
F
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004361:Drug Tolerance; D004381:Duodenal Ulcer / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015282:Octreotide / Q000627:therapeutic use*; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy*; D010919:Placebos; D013276:Stomach Ulcer / Q000150:complications*
D010919:Placebos; D015282:Octreotide