Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial

• Published in: Clinical therapeutics Vol. 38; no. 8; pp. 1902 - 1911.e2
• Main Authors: Bisschops, Raf, MD, PhD, De Ruyter, Vincent, MSc, Demolin, Gauthier, MD, Baert, Didier, MD, Moreels, Tom, MD, PhD, Pattyn, Piet, MD, PhD, Verhelst, Hans, MD, Lepoutre, Luc, MD, Arts, Joris, MD, Caenepeel, Philip, MD, PhD, Ooghe, Patrick, MD, Codden, Thierry, MD, Maisonobe, Pascal, MSc, Petrens, Elke, MSc, Tack, Jan, MD, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2016; Elsevier Limited
• Subjects: Adult; Aged; chronic idiopathic refractory diarrhea; Clinical trials; Consent; Diarrhea; Diarrhea - drug therapy; Family medical history; Female; gastrointestinal motility; Gastrointestinal surgery; Growth hormones; Humans; Inflammatory bowel disease; Internal Medicine; Irritable bowel syndrome; lanreotide Autogel; Male; Medical Education; Middle Aged; Motility; open-label clinical trial; Peptides, Cyclic - administration & dosage; Polypeptides; Prospective Studies; Quality of Life; Somatostatin - administration & dosage; Somatostatin - analogs & derivatives; somatostatin analogue; Statistical analysis; Studies; Surveys and Questionnaires; Treatment Outcome; Tumors; Belgium; gastrointestinal motility; lanreotide Autogel; somatostatin analogue; chronic idiopathic refractory diarrhea; open-label clinical trial
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2016.06.012

Abstract Purpose 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. Methods 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. Findings 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. Implications 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 Identification: NCT00891371; Eudract CT 2009-009356-20