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A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental
Hannibal Person1, Jeffrey S Hyams2, Rinarani M Sanghavi3
1Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.
Insights
Linaclotide effectively improved functional constipation in children with neurodevelopmental disorders, showing high adherence and a favorable safety profile. This treatment offers a promising option for this challenging pediatric population.
Area of Science:
- Pediatric Gastroenterology
- Neurodevelopmental Disorders
- Pharmacology
Background:
- Functional constipation (FC) is prevalent in children with neurodevelopmental disorders (NDD).
- Treatment challenges in this population include adherence and medication tolerability.
- Linaclotide is a guanylate cyclase-C agonist used for chronic idiopathic constipation.
Purpose of the Study:
- To assess the efficacy and safety of linaclotide in pediatric patients with FC and comorbid NDD.
- To evaluate linaclotide's impact on bowel movement frequency, stool consistency, and straining.
- To determine adherence and tolerability of linaclotide in this specific patient group.
Main Methods:
- Post hoc analysis of a Phase 3, randomized, placebo-controlled study.
- Inclusion of pediatric patients aged 6-17 years with FC and NDD.
- Oral linaclotide 72 µg once daily for 12 weeks, with primary endpoint of change in weekly spontaneous bowel movement frequency.
Main Results:
- Linaclotide significantly increased weekly spontaneous bowel movement frequency compared to placebo (SMD 0.688).
- Improvements were observed in stool consistency and straining scores with linaclotide.
- High dosing compliance (≥96%) and a well-tolerated safety profile were noted.
Conclusions:
- Linaclotide 72 µg once daily demonstrated efficacy in improving constipation outcomes in children with FC and NDD.
- The treatment showed high adherence and a safety profile consistent with previous studies.
- Linaclotide is a viable therapeutic option for pediatric FC in the presence of NDD.
Objectives:
Functional constipation (FC) is common in children with comorbid neurodevelopmental disorders (NDD) and its optimal treatment may be challenged by adherence and medication tolerability issues in this population. We assessed the efficacy and safety of linaclotide in pediatric patients with FC and NDD.
Methods:
This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotide 72 µg once daily for 12 weeks in patients aged 6-17 years with FC and NDD. The primary endpoint was change from baseline (CFB) in weekly spontaneous bowel movement (SBM) frequency. In efficacy comparisons, an absolute standardized mean difference (SMD) > 0.2 was considered indicative of a treatment difference.
Results:
In this analysis of 57 pediatric patients (linaclotide n = 25; placebo n = 32), 91% had attention-deficit/hyperactivity disorder; other NDDs included autism spectrum disorder, tic disorders, and sensory processing disorders. CFB in weekly SBM frequency over 12 weeks was greater with linaclotide versus placebo (2.09 vs. 0.59, respectively; SMD 0.688). Linaclotide was also associated with greater improvements relative to placebo in stool consistency (CFB 1.37 vs. 0.55, respectively) and straining score (CFB -0.98 vs. -0.59). Most patients (≥96%) achieved ≥80% dosing compliance with once-daily administration of linaclotide or placebo. Linaclotide was well tolerated, with a safety profile consistent with that reported previously.
Conclusions:
In children with FC and comorbid NDD, linaclotide 72 µg once daily was associated with improved constipation outcomes, high adherence, and a well-tolerated safety profile, similar to that seen in the overall study population.
Trial Registration:
ClinicalTrials.gov identifier: NCT04026113 (https://clinicaltrials.gov/study/NCT04026113).
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