Evaluation of lanreotide effects on human exocrine pancreatic secretion after a single dose: preliminary study

BACKGROUND: Total parenteral nutrition and somatostatin or analogues represent a consolidated therapeutic approach for external fistulas, a frequent complication of major pancreatic surgery. AIMS: To establish the effects of the somatostatin analogue lanreotide on exocrine pancreatic secretion. METHODS: Eight patients, undergoing pancreaticoduodenectomy for malignancy, were enrolled in the trial. The volume and composition of pancreatic secretion were evaluated after one single subcutaneous injection of lanreotide 0.5 mg or placebo in a randomised, double-blind cross-over trial. RESULTS: In the seven patients completing the study, the 24-h output volume was 208.6+/-41.3 and 253.9+/-72.4 ml after lanreotide and placebo, respectively. During the first 6 hours values were 48.1+/-14.7 and 77.6+/-21.4 ml (p=0. 02). No significant difference between treatments was detected in the qualitative composition of 24-h pancreatic secretion, although bicarbonate secretion remained lower after the active drug at all the observation intervals. Peak lanreotide levels were detected 15-30 min after drug injection. Clinical and laboratory tolerability was good. CONCLUSIONS: Lanreotide induced a statistically significant reduction in the output volume with respect to placebo in the first 6 hours after administration, but not thereafter. The present results encourage a new study to be undertaken in a larger sample and with a multiple dosing scheme of treatment.