title: Octreotide for the treatment of diarrhoea in patients with ileal pouch anal anastomosis: a placebo-controlled crossover study.
abstract: OBJECTIVE
  Diarrhoea with urgency is a debilitating long-term complication of ileal pouch anal anastomosis (IPAA) after a proctocolectomy. Somatostatin analogues are used to control diarrhoea and high-output ostomies. Hence, we designed a prospective, double-blind, crossover trial to explore the efficacy and tolerability of octreotide to reduce diarrhoea in adult patients with IPAA.
  
  
  METHODS
  Patients were randomized to octreotide subcutaneously (SC), 500 μg three times daily (t.i.d.), or matching placebo SC for 7 days. Responders (a reduction in stool frequency of three or more stools per 24-h period and with a reduction in stool frequency of at least 30% after 7 days of treatment compared with baseline; the primary end-point) remained in the same group and nonresponders could cross over to the alternative treatment for 7 days. Open-label octeotide LAR 30 mg was offered to all responders on day 14. Flexible pouchoscopy with biopsies was performed at baseline in all patients and was repeated on days 7 and 14 in patients with pouchitis.
  
  
  RESULTS
  Fifteen patients (11 men, median age 52 years), all with ulcerative colitis, were randomized. Three patients were withdrawn for side effects during the blinded phase. Response was achieved by two of 12 and two of 11 patients treated with octreotide or placebo, respectively (including crossover, P = 0.9). The median stool frequency remained stable in both groups [Δoctreotide: 0 (IQR, -4 to 0), Δplacebo: -1 (IQR, -1 to 1), P = 0.45]. Octreotide had no effect on the modified pouch disease activity index (mPDAI), and pouchitis persisted in five of six subjects with pouchitis at onset. One subject received open-label octreotide LAR.
  
  
  CONCLUSIONS
  Octreotide has no clear beneficial effect on the stool pattern or on pouchitis severity in patients with high stool frequency after IPAA.
authors.affiliation: University of Leuven Hospitals, Leuven, Belgium. gert.vanassche@uzleuven.be
authors.forename: G
authors.initials: G
authors.lastname: Van Assche
authors.forename: M
authors.initials: M
authors.lastname: Ferrante
authors.forename: S
authors.initials: S
authors.lastname: Vermeire
authors.forename: M
authors.initials: M
authors.lastname: Noman
authors.forename: K
authors.initials: K
authors.lastname: Rans
authors.forename: L
authors.initials: L
authors.lastname: Van der Biest
authors.forename: F
authors.initials: F
authors.lastname: Penninckx
authors.forename: A
authors.initials: A
authors.lastname: Wolthuis
authors.forename: P
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: A
authors.initials: A
authors.lastname: D'Hoore
mesh_terms: D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000601:surgery; D039021:Colonic Pouches; D018592:Cross-Over Studies; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy*; D019449:Pouchitis / Q000150:complications / Q000188:drug therapy; D016737:Proctocolectomy, Restorative; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D015282:Octreotide