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

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• 作者：Raf Bisschops ; MD ; PhD¹ ; Vincent De Ruyter ; MSc² ; ^{Vincent.de.ruyter@ipsen.com" class="auth_mail" title="E-mail the corresponding author} ; Gauthier Demolin ; MD³ ; Didier Baert ; MD⁴ ; Tom Moreels ; MD ; PhD⁵ ; Piet Pattyn ; MD ; PhD⁶ ; Hans Verhelst ; MD⁷ ; Luc Lepoutre ; MD⁸ ; Joris Arts ; MD⁹ ; Philip Caenepeel ; MD ; PhD¹⁰ ; Patrick Ooghe ; MD¹¹ ; Thierry Codden ; MD¹² ; Pascal Maisonobe ; MSc¹³ ; Elke Petrens ; MSc² ; Jan Tack ; MD ; PhD¹
• 关键词：chronic idiopathic refractory diarrhea ; gastrointestinal motility ; lanreotide Autogel ; open-label clinical trial ; somatostatin analogue
• 刊名：Clinical Therapeutics
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：38
• 期：8
• 页码：1902-1911.e2
• 全文大小：556 K

文摘

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