Efficacy of lubiprostone for functional constipation treatment in adolescents and children: Randomized controlled trial.
J Pediatr Gastroenterol Nutr
; 78(4): 800-809, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-38314885
ABSTRACT
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Estreñimiento
/
Laxativos
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Child
/
Humans
Idioma:
En
Revista:
J Pediatr Gastroenterol Nutr
Año:
2024
Tipo del documento:
Article
País de afiliación:
Egipto