Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.
OBJECTIVE
Continuous intravenous infusion of somatostatin improves the natural course of digestive fistulae. Lanreotide 30 mg PR is a synthetic analogue of somatostatin with pharmacological activity extending to at least 10 days after intramuscular administration. Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study.


METHODS
Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point) and continued the double-blind treatment to a maximum of 6 injections at 10-day intervals. Other endpoints included fistula closure rate and time to closure. Blind was lifted for nonresponders, and those initially on placebo were then treated with open-label lanreotide.


RESULTS
Following the first double-blind injection, 35 of 54 patients (64.8%) on lanreotide were responders versus 20 of 53 (37.7%) on placebo, ie, a 3.1 times higher response likelihood on lanreotide compared with placebo (P = 0.006). Group mean reduction of fistula output at 72 hours was 45.1% and 8.9%, respectively (P = 0.005). Lanreotide compared with placebo had no effect on closure rate which averaged 77% but median time to fistula closure was shorter on lanreotide, based on Kaplan-Meier analysis, although no statistical significance was achieved.


CONCLUSIONS
Compared with placebo, intramuscular lanreotide 30 mg PR significantly decreases digestive fistulae output at Day 3 and shortens time to fistula closure by 9 days. ClinicalTrials.gov registration number: NCT00729313.
Gayral
François
F
Service de Chirurgie Digestive, CHU Bicêtre, Kremlin Bicêtre, Paris, France.
Campion
Jean-Pierre
JP
Regimbeau
Jean-Marc
JM
Blumberg
Joëlle
J
Maisonobe
Pascal
P
Topart
Philippe
P
Wind
Philippe
P
D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017577:Cutaneous Fistula / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D007412:Intestinal Fistula / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010185:Pancreatic Fistula / Q000188:drug therapy*; D010456:Peptides, Cyclic / Q000008:administration & dosage*; D013004:Somatostatin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin