Raf Bisschops1, Vincent De Ruyter2, Gauthier Demolin3, Didier Baert4, Tom Moreels5, Piet Pattyn6, Hans Verhelst7, Luc Lepoutre8, Joris Arts9, Philip Caenepeel10, Patrick Ooghe11, Thierry Codden12, Pascal Maisonobe13, Elke Petrens14, Jan Tack1. 1. Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. 2. Ipsen NV, Merelbeke, Belgium. Electronic address: Vincent.de.ruyter@ipsen.com. 3. Department of Gastroenterology, CHC Clinique Saint-Joseph, Liège, Belgium. 4. Department of Gastroenterology, Maria Middelares Medical Centre, Ghent, Belgium. 5. Department of Gastroenterology, Antwerp University Hospital, Edegem, Belgium. 6. Department of Abdominal Surgery, Ghent University Hospital, Ghent, Belgium. 7. Department of Abdominal Surgery, Oost-Limburg Hospital, Genk, Belgium. 8. Department of Gastroenterology, Onze-Lieve-Vrouwziekenhuis Hospital, Aalst, Belgium. 9. Department of Gastroenterology, University Hospital Sint-Lucas, Brugge, Belgium. 10. Department of Gastroenterology, Oost-Limburg Hospital, Genk, Belgium. 11. Department of Gastroenterology, Charleroi University Hospital, Charleroi, Belgium. 12. Department of Gastroenterology, Health Centre des Fagnes, Chimay, Belgium. 13. Ipsen, Boulogne-Billancourt, France. 14. Ipsen NV, Merelbeke, Belgium.
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.
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.