Efficacy of lubiprostone for functional constipation treatment in adolescents and children: Randomized controlled trial
Objectives Adolescent and pediatric functional constipation (FC) is a common clinical problem. Currently, data on lubiprostone for the treatment of pediatric FC are scarce. This study investigated the efficacy and safety of lubiprostone in the treatment of pediatric FC. Methods In a single‐blinded,...
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| Published in: | Journal of pediatric gastroenterology and nutrition Vol. 78; no. 4; pp. 800 - 809 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01-04-2024
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Objectives
Adolescent and pediatric functional constipation (FC) is a common clinical problem. Currently, data on lubiprostone for the treatment of pediatric FC are scarce. This study investigated the efficacy and safety of lubiprostone in the treatment of pediatric FC.
Methods
In a single‐blinded, randomized controlled study, we included 280 patients aged 8–18 years with FC. Patients were randomized either to a weight‐based lubiprostone dose (n = 140) or conventional laxatives (n = 140), including lactulose, bisacodyl, or sodium picosulfate, for 12 weeks, followed by 4 weeks posttreatment follow‐up.
Results
Improvement in constipation was achieved in 128 (91.4%) patients in the lubiprostone group, and in 48 (34.3%) patients of the conventional therapy group (p < 0.001) and was sustained after treatment discontinuation. One quarter of the lubiprostone group experienced the first spontaneous bowel motion within 48 h after dose initiation. A total of 75.7% of the lubiprostone group could achieve and sustain Bristol stool form of 3 or 4 during the last 4 weeks of therapy and through the 4 weeks of follow‐up versus 50 (35.7%) patients in the conventional therapy group (p < 0.001). No life‐threatening adverse drug reactions were encountered, and no treatment‐related discontinuation. Mild self‐limited colicky abdominal pain and headache were the most prevalent side effects in the lubiprostone group.
Conclusions
Lubiprostone is an effective and well‐tolerated pharmacotherapy for youthful age and pediatric age groups, which may alter the paradigm of pediatric FC treatment.
What is Known
Current treatment of childhood functional constipation (FC) is challenging.
Lubiprostone efficacy for childhood and adolescents' FC is not fully evaluated.
What is New
Lubiprostone is an effective and safe therapy for childhood and adolescent functional constipation.
Lubiprostone effect is found to be sustained after treatment discontinuation. |
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| Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
| ISSN: | 0277-2116 1536-4801 |
| DOI: | 10.1002/jpn3.12135 |