Efficacy of lubiprostone for functional constipation treatment in adolescents and children: Randomized controlled trial.

Autor: Elkaragy ES; Department of Pediatrics, Alexandria University, Alexandria, Egypt., Shamseya MM; Department of Clinical and Experimental Internal Medicine, Alexandria University, Alexandria, Egypt., Metwally RH; Department of Pediatrics, Alexandria University, Alexandria, Egypt., Mansour ER; Department of Physical Medicine, Rheumatology, and Rehabilitation, Faculty of Medicine, Alexandria University, Alexandria, Egypt., Lashen SA; Department of Internal Medicine (Hepatology & Gastroenterology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Jazyk: angličtina
Zdroj: Journal of pediatric gastroenterology and nutrition [J Pediatr Gastroenterol Nutr] 2024 Apr; Vol. 78 (4), pp. 800-809. Date of Electronic Publication: 2024 Feb 05.
DOI: 10.1002/jpn3.12135
Abstrakt: 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.
(© 2024 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)
Databáze: MEDLINE
Externí odkaz: