2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as Three Times Daily in Maintenance of Remission in Ulcerative Colitis

Autor: Mitsuo Iida, Yasuo Suzuki, Toshifumi Hibi, Haruo Nishino, Takanori Okubo, Hiroaki Ito, Toshihide Ohmori, Tadashi Yokoyama, Takehiro Arai
Rok vydání: 2017
Předmět:
Adult
Male
0301 basic medicine
medicine.medical_specialty
Administration
Oral
Equivalence Trials as Topic
Gastroenterology
mesalamine
Drug Administration Schedule
law.invention
Young Adult
03 medical and health sciences
Remission induction
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Internal medicine
maintenance of remission
medicine
Humans
Immunology and Allergy
3 times daily administration
Patient compliance
Asacol
ulcerative colitis
business.industry
Anti-Inflammatory Agents
Non-Steroidal
Remission Induction
Middle Aged
Prognosis
medicine.disease
Ulcerative colitis
Surgery
Clinical trial
030104 developmental biology
Multicenter study
Disease remission
once daily administration
Patient Compliance
Colitis
Ulcerative
Female
030211 gastroenterology & hepatology
Once daily
Original Clinical Articles
business
Follow-Up Studies
Zdroj: Inflammatory Bowel Diseases
ISSN: 1078-0998
DOI: 10.1097/mib.0000000000001065
Popis: Article first Published online 31 March 2017
Background: The noninferiority of pH-dependent release mesalamine (Asacol) once daily (QD) to 3 times daily (TID) administration was investigated. Methods: This was a phase 3, multicenter, randomized, double-blind, parallel-group, active-control study, with dynamic and stochastic allocation using central registration. Patients with ulcerative colitis in remission (a bloody stool score of 0, and an ulcerative colitis disease activity index of ≤2), received the study drug (Asacol 2.4 g/d) for 48 weeks. The primary efficacy endpoint of the nonrecurrence rate was assessed on the full analysis set. The noninferiority margin was 10%. Results: Six hundred and four subjects were eligible and were allocated; 603 subjects received the study drug. The full analysis set comprised 602 subjects (QD: 301, TID: 301). Nonrecurrence rates were 88.4% in the QD and 89.6% in the TID. The difference between nonrecurrence rates was −1.3% (95% confidence interval: −6.2, 3.7), confirming noninferiority. No differences in the safety profile were observed between the two treatment groups. On post hoc analysis by integrating the QD and the TID, nonrecurrence rate with a mucosal appearance score of 0 at determination of eligibility was significantly higher than the score of 1. The mean compliance rates were 97.7% in the QD and 98.1% in the TID. Conclusions: QD dosing with Asacol is as effective and safe as TID for maintenance of remission in patients with ulcerative colitis. Additionally, this study indicated that maintaining a good mucosal state is the key for longer maintenance of remission.
Databáze: OpenAIRE
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