title: Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.
abstract: 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.
authors: Service de Chirurgie Digestive, CHU Bicêtre, Kremlin Bicêtre, Paris, France.
authors: François
authors: F
authors: Gayral
authors: Jean-Pierre
authors: JP
authors: Campion
authors: Jean-Marc
authors: JM
authors: Regimbeau
authors: Joëlle
authors: J
authors: Blumberg
authors: Pascal
authors: P
authors: Maisonobe
authors: Philippe
authors: P
authors: Topart
authors: Philippe
authors: P
authors: Wind
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin