title: Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial.
abstract: Chronic idiopathic diarrhea is the passage of loose stools >3 times daily, or a stool weight >200 g/d, persisting for >4 weeks without clear clinical cause. Patients refractory to standard anti-diarrhetics have limited treatment options. Somatostatin analogues have the ability to reduce gastrointestinal secretions and motility. This study evaluated the efficacy and safety of lanreotide Autogel(*) 120 mg in chronic idiopathic diarrhea.
  
  
  
  Other anti-diarrhetics were not allowed during the study and were stopped at screening. Patients received lanreotide Autogel 120 mg at baseline and day 28. Stool frequency and consistency (Bristol Stool Scale) were recorded; quality of life (QoL) was assessed using the 36-item Short Form Health Survey and irritable bowel syndrome QoL questionnaires; adverse events were monitored. The primary outcome was the proportion of patients with a reduction of ≥50% or normalization to a mean of ≤3 stools/d at day 28.
  
  
  
  Thirty-three patients with >3 stools/d at baseline were included; mean (SD) age was 55.2 (16.4) years. Fourteen patients (42.4%) had a response to lanreotide Autogel at day 28 and 17 (51.5%) at day 56. Mean (SD) number of stools decreased significantly from 5.7 (2.2) at baseline to 3.7 (2.2) at day 56 overall (n = 32; P < 0.001). Significant and clinically meaningful improvements in disease-specific QoL were found in the overall populations. No new safety signals emerged.
  
  
  
  Lanreotide Autogel 120 mg decreased symptoms in these patients with chronic idiopathic refractory diarrhea, and meaningfully improved QoL. These finding have to be confirmed in further clinical trials. ClinicalTrials.gov
  
  
  
  NCT00891371; Eudract CT 2009-009356-20.
authors.affiliation: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Raf
authors.initials: R
authors.lastname: Bisschops
authors.affiliation: Ipsen NV, Merelbeke, Belgium. Electronic address: Vincent.de.ruyter@ipsen.com.
authors.forename: Vincent
authors.initials: V
authors.lastname: De Ruyter
authors.affiliation: Department of Gastroenterology, CHC Clinique Saint-Joseph, Liège, Belgium.
authors.forename: Gauthier
authors.initials: G
authors.lastname: Demolin
authors.affiliation: Department of Gastroenterology, Maria Middelares Medical Centre, Ghent, Belgium.
authors.forename: Didier
authors.initials: D
authors.lastname: Baert
authors.affiliation: Department of Gastroenterology, Antwerp University Hospital, Edegem, Belgium.
authors.forename: Tom
authors.initials: T
authors.lastname: Moreels
authors.affiliation: Department of Abdominal Surgery, Ghent University Hospital, Ghent, Belgium.
authors.forename: Piet
authors.initials: P
authors.lastname: Pattyn
authors.affiliation: Department of Abdominal Surgery, Oost-Limburg Hospital, Genk, Belgium.
authors.forename: Hans
authors.initials: H
authors.lastname: Verhelst
authors.affiliation: Department of Gastroenterology, Onze-Lieve-Vrouwziekenhuis Hospital, Aalst, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Lepoutre
authors.affiliation: Department of Gastroenterology, University Hospital Sint-Lucas, Brugge, Belgium.
authors.forename: Joris
authors.initials: J
authors.lastname: Arts
authors.affiliation: Department of Gastroenterology, Oost-Limburg Hospital, Genk, Belgium.
authors.forename: Philip
authors.initials: P
authors.lastname: Caenepeel
authors.affiliation: Department of Gastroenterology, Charleroi University Hospital, Charleroi, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ooghe
authors.affiliation: Department of Gastroenterology, Health Centre des Fagnes, Chimay, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Codden
authors.affiliation: Ipsen, Boulogne-Billancourt, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Maisonobe
authors.affiliation: Ipsen NV, Merelbeke, Belgium.
authors.forename: Elke
authors.initials: E
authors.lastname: Petrens
authors.affiliation: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
mesh_terms: D000328:Adult; D000368:Aged; D003967:Diarrhea / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage*; D011446:Prospective Studies; D011788:Quality of Life; D013004:Somatostatin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D010456:Peptides, Cyclic; C060347:lanreotide; D013004:Somatostatin
keywords: chronic idiopathic refractory diarrhea; gastrointestinal motility; lanreotide Autogel; open-label clinical trial; somatostatin analogue