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
Key words
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Article info
Publication history
Published online: July 13, 2016
Accepted:
June 15,
2016
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
