1. Once- Versus Twice-daily Mesalazine to Induce Remission in Paediatric Ulcerative Colitis: A Randomised Controlled Trial
- Author
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Ron Shaoul, Shlomi Cohen, Avi On, Oren Ledder, Efrat Broide, Sarit Peleg, Yael Mozer-Glassberg, Dan Turner, Michal Kori, Arie Levine, Baruch Yerushalmi, Hussein Shamaly, Kaija-Leena Kolho, Eyal Shteyer, Clinicum, Children's Hospital, Lastentautien yksikkö, and HUS Children and Adolescents
- Subjects
Male ,CHILDREN ,Activity index ,THERAPY ,Gastroenterology ,Inflammatory bowel disease ,law.invention ,DOUBLE-BLIND ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,030212 general & internal medicine ,PREDICTORS ,10. No inequality ,Child ,Mesalamine ,Anti-Inflammatory Agents, Non-Steroidal ,Remission Induction ,Drugs ,General Medicine ,Ulcerative colitis ,3. Good health ,Child, Preschool ,030211 gastroenterology & hepatology ,Female ,medicine.medical_specialty ,Adolescent ,Drug Administration Schedule ,CLINICAL-TRIAL ,03 medical and health sciences ,Mesalazine ,Internal medicine ,medicine ,Humans ,Dosing ,Colitis ,ulcerative colitis ,ORAL 5-AMINOSALICYLIC ACID ,business.industry ,ACTIVITY INDEX ,medicine.disease ,Surgery ,Clinical trial ,MAINTENANCE ,chemistry ,3121 General medicine, internal medicine and other clinical medicine ,Colitis, Ulcerative ,business ,INFLAMMATORY-BOWEL-DISEASE - Abstract
Background: Trials in adults suggested that, in ulcerative colitis [UC], once-daily [OD] dosing of 5-ASA [5-amino salicylic acid] may be as or more effective than twice-daily [BD] dosing. In this induction of remission, investigator-blinded, randomised controlled-trial, we aimed to compare effectiveness and safety of once-versus twice-daily mesalazine in paediatric UC. Methods: Children, aged 4-18 years with a PUCAI [Paediatric Ulcerative Colitis Activity Index] of 10-55 points at inclusion, were randomised in blocks of six with blinded allocation to OD or BD mesalazine, using a weight-based dosing table. The primary outcome was mean PUCAI score at Week 6. Results: A total of 83/86 randomised children were eligible and analysed: 43 in the OD group and 40 in the BD group (mean age 14 +/- 2.7 years, 43 [52%] males, 51 [62%] extensive colitis). The groups did not differ with regard to disease activity or any other parameter at baseline. There was no difference in median PUCAI score between the OD group and BD group at Week 6: 15 (interquartile range [IQR] 5-40) versus 10 [0-40]; p = 0.48]. Response was seen in 25 [60%] OD versus 25 [63%] BD dosing [p = 0.78]. Proportion of children in remission [PUCAI 0.2]. Conclusions: In this first randomised controlled trial in children, no differences were found between OD and BD dosing for any clinical outcome. Remission was achieved in 35% of children treated with mesalazine for active UC.
- Published
- 2016