The role of somatostatin and a long-acting analogue, SMS 201-995, in acute bleeding due to peptic ulceration.

During the past 10 years several drugs have been tested for their efficacy in controlling acute upper gastrointestinal (GI) bleeding. However, since the bleeding is self-limiting in 70-80% of cases, any drug tested in all cases of upper GI bleeding will have to perform extremely well to prove significantly better than placebo. Natural somatostatin has recently been investigated on the basis that it reduces gastric acid secretion and splanchnic blood flow. In severe cases of bleeding, an average success rate of 87% has been achieved, the highest ever reported for a drug in this indication. In unselected bleeders, however, somatostatin was no more effective than placebo. The long-acting somatostatin analogue, SMS 201-995, was investigated in the current studies and was found to be more potent than natural somatostatin in reducing gastric acid secretion and in reducing intestinal mucosal blood flow for a substantially longer period. A pilot study of SMS 201-995 in the treatment of severe acute upper GI bleeding resulted in cessation of bleeding, with no rebleeding during or within 24 h after the trial in 8 of 10 patients. No side effects were reported. The planning of a large controlled trial is described.