Intramuscular Lanreotide 30 Mg Lp in the Treatment of Digestive Fistulae - a Multicentre, Randomized, Placebo-Controlled, Double-Blind Study
Philippe Topart*1, Jean-Pierre Campion2, Philippe Wind3, Jean-Marc Regimbeau4, FrançOis Gayral5
1Service de Chirurgie Digestive, Hôpital de la Cavale Blanche, Brest, France; 2Service de Chirurgie Digestive, Hôpital Pontchaillou, Rennes, France; 3Service de Chirurgie Digestive, Hôpital Avicenne, Bobigny, France; 4Service de Chirurgie Digestive, Hôpital Nord, Amiens, France; 5Service de Chirurgie Digestive, Hôpital Bicêtre, Kremlin Bicêtre, France
Background: Somatostatin, administered as a continuous intravenous infusion over up to 3 weeks, has been shown to improve the resolution of digestive fistulae. Lanreotide 30 mg LP, a long-acting synthetic analogue of somatostatin, has a somatostatin-like pharmacological activity extending to at least 10 days after one intramuscular (IM) administration. Aim: To assess the efficacy of IM lanreotide 30 mg LP as a curative treatment of digestive fistulaePatients and
Methods: Patients with pancreatic or duodenal fistulae were randomized to receive double-blind a first IM administration of either lanreotide 30 mg LP or placebo. Patients with a > or = 50% reduction of the fistula output within the next 72 hours were considered to be responders and continued double-blind treatment to a maximum of 6 IM injections at 10-day intervals. Non-responders initially on placebo received open-label lanreotide. Those initially on lanreotide received alternative treatments. The primary endpoint was the percentage of responders at 72 hours.
Results: 107 patients with digestive fistulae were randomized to lanreotide or placebo. Demographic characteristics of the patients and outcomes at 72 hours are tabulated. For responders, median fistula closure time was 14 days on lanreotide versus 17 days on placebo; for 25% of the patients, fistula closure time was 6 days on lanreotide versus 13 days on placebo. Fistula closure rate at the end of treatment was 71.4% and 82.6%, respectively. For the non-responders subsequently treated open-label with lanreotide, median closure time was 37 days.
Conclusion: Compared to placebo, lanreotide 30 mg LP in IM administration every 10 days signficantly reduces digestive fistulae output within 72 hours after the first injection and shortens fistula closure time.
Results
| Characteristics | PlaceboN=53 | LanreotideN=54 | P |
| Mean age (SD) | 54.0 (14.4) | 54.8 (15.6) | |
| Male % | 60.4 | 50.0 | |
| Fistula locationPancreatic - n (%)Duodenal -n (%) | 35 (66)18 (34) | 36 (67)18 (33) | |
| Outcomes 72 hours | |||
| Respondersn (%) | 20 (37.7) | 35 (64.8) | 0.006; OR = 3.07 [1.39; 6.78] |
| Global output reduction (%) | 8.9 | 45.1 | 0.005 |
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