Linaclotide Proves Effective for Pediatric Constipation
In a significant development for pediatric gastroenterology, linaclotide, a guanylate cyclase C agonist, has been granted approval by the US Food and Drug Administration (FDA) for the treatment of functional constipation in children aged 6–17. The approval comes on the heels of a successful phase 3 study, showcasing the drug's efficacy and safety in this specific patient population.
This study was published in the journal The Lancet: Gastroenterology & Hepatology by Carlo Di. and colleagues. The randomized, double-blind, placebo-controlled, multicenter study involved 330 pediatric patients across seven countries. Enrolled participants, aged 6–17, met modified Rome III criteria for functional constipation. The study aimed to assess the impact of oral linaclotide at a daily dose of 72 μg over 12 weeks compared to a placebo.
Key Findings:
Patients treated with linaclotide demonstrated a significant improvement in the frequency rate of spontaneous bowel movements (SBMs) compared to the placebo group.
Linaclotide also showed a notable enhancement in stool consistency, indicating its efficacy in addressing constipation-related symptoms.
The most reported treatment-emergent adverse event (TEAE) associated with linaclotide was diarrhea, reported by 4% of patients, while the placebo group reported COVID-19 as the most frequent TEAE (3%).
Notably, linaclotide was well-tolerated, with the majority of patients completing the 12-week treatment period.
Following these promising results, linaclotide has received FDA approval for the treatment of functional constipation in pediatric patients aged 6–17. The drug's approval provides a valuable addition to the therapeutic options available for managing this common gastrointestinal concern in children.
The study's positive outcomes highlight linaclotide as an efficacious and well-tolerated treatment for functional constipation in the pediatric population. As the FDA approves its use in this indication, healthcare professionals gain an additional tool to address constipation-related issues in children. Further research may explore the long-term safety and effectiveness of linaclotide in pediatric patients.
Linaclotide's approval marks a significant step forward in pediatric gastroenterology, offering a targeted and effective solution for functional constipation. The successful study results provide clinicians with confidence in the drug's efficacy and safety, underscoring its potential to improve the quality of life for children grappling with this gastrointestinal condition.
Reference:
Di Lorenzo, C., Khlevner, J., Rodriguez-Araujo, G., Xie, W., Huh, S. Y., Ando, M., Hyams, J. S., Nurko, S., Benninga, M. A., Simon, M., Hewson, M. E., & Saps, M. Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. The Lancet. Gastroenterology & Hepatology,2024. https://doi.org/10.1016/s2468-1253(23)00398-9
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