BACKGROUND:Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC. METHODS: Randomized, double-blind, placebo-controlled trial of patients (n=209 MG, n=96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding=0, mucosal appearance <2] who tookMG 1.5 g or placeboonce-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. RESULTS: The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. CONCLUSIONS: Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.
RCT Entities:
BACKGROUND:Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC. METHODS: Randomized, double-blind, placebo-controlled trial of patients (n=209 MG, n=96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding=0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. RESULTS: The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. CONCLUSIONS: Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.
Authors: Cynthia W Ko; Siddharth Singh; Joseph D Feuerstein; Corinna Falck-Ytter; Yngve Falck-Ytter; Raymond K Cross Journal: Gastroenterology Date: 2018-12-18 Impact factor: 22.682
Authors: Vipul Jairath; Guangyong Zou; Claire E Parker; John K Macdonald; Mahmoud H Mosli; Reena Khanna; Lisa M Shackelton; Margaret K Vandervoort; Turki AlAmeel; Mohammad Al Beshir; Majid AlMadi; Talal Al-Taweel; Nathan S S Atkinson; Sujata Biswas; Thomas P Chapman; Parambir S Dulai; Mark A Glaire; Daniel Hoekman; Andreas Koutsoumpas; Elizabeth Minas; Mark A Samaan; Simon Travis; Geert D'Haens; Barrett G Levesque; William J Sandborn; Brian G Feagan Journal: J Crohns Colitis Date: 2016-01-07 Impact factor: 9.071
Authors: Ma Somsouk; Richard M Dunham; Michelle Cohen; Rebecca Albright; Mohamed Abdel-Mohsen; Teri Liegler; Jeffrey Lifson; Michael Piatak; Robert Gorelick; Yong Huang; Yuaner Wu; Priscilla Y Hsue; Jeffrey N Martin; Steven G Deeks; Joseph M McCune; Peter W Hunt Journal: PLoS One Date: 2014-12-29 Impact factor: 3.240
Authors: Vipul Jairath; G Y Zou; Claire E Parker; John K MacDonald; Turki AlAmeel; Mohammad Al Beshir; Majid A Almadi; Talal Al-Taweel; Nathan Ss Atkinson; Sujata Biswas; Thomas Chapman; Parambir S Dulai; Mark A Glaire; Daniël R Hoekman; Andreas Koutsoumpas; Elizabeth Minas; Mahmoud H Mosli; Mark Samaan; Reena Khanna; Simon Travis; Geert D'Haens; William J Sandborn; Brian G Feagan Journal: Cochrane Database Syst Rev Date: 2017-09-08