Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial
| Autor: | Hans Verhelst, Jan Tack, Patrick Ooghe, Thierry Codden, Elke Petrens, Raf Bisschops, Luc Lepoutre, Tom G. Moreels, D. Baert, Pascal Maisonobe, Piet Pattyn, Philip Caenepeel, Joris Arts, Vincent De Ruyter, Gauthier Demolin |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Diarrhea Male medicine.medical_specialty Octreotide Gastroenterology Peptides Cyclic 03 medical and health sciences 0302 clinical medicine Bristol stool scale Quality of life Internal medicine Surveys and Questionnaires medicine Humans Pharmacology (medical) Prospective Studies Adverse effect Prospective cohort study Irritable bowel syndrome Aged Pharmacology business.industry Pharmacology. Therapy Middle Aged medicine.disease Surgery Clinical trial Treatment Outcome 030220 oncology & carcinogenesis Quality of Life 030211 gastroenterology & hepatology Female medicine.symptom business Somatostatin medicine.drug |
| Zdroj: | Clinical therapeutics |
| ISSN: | 1879-114X 0089-1371 0149-2918 |
| Popis: | 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 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 (C) 2016 Elsevier HS Journals, Inc. All rights reserved. |
| Databáze: | OpenAIRE |
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