Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations

A pooled analysis from two randomised controlled trials

G. R. Lichtenstein, S. Zakko, G. L. Gordon, U. Murthy, S. Sedghi, Ronald Pruitt, K. Merchant, E. Bortey, W. P. Forbes

    Research output: Contribution to journalArticle

    7 Citations (Scopus)

    Abstract

    Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint). Conclusion Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. identifiers NCT00744016, NCT00767728.

    Original languageEnglish (US)
    Pages (from-to)126-134
    Number of pages9
    JournalAlimentary Pharmacology and Therapeutics
    Volume36
    Issue number2
    DOIs
    StatePublished - Jul 1 2012

    Fingerprint

    Mesalamine
    Ulcerative Colitis
    Randomized Controlled Trials
    Placebos
    Maintenance
    Recurrence
    Hemorrhage
    Random Allocation

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology
    • Pharmacology (medical)

    Cite this

    Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations : A pooled analysis from two randomised controlled trials. / Lichtenstein, G. R.; Zakko, S.; Gordon, G. L.; Murthy, U.; Sedghi, S.; Pruitt, Ronald; Merchant, K.; Bortey, E.; Forbes, W. P.

    In: Alimentary Pharmacology and Therapeutics, Vol. 36, No. 2, 01.07.2012, p. 126-134.

    Research output: Contribution to journalArticle

    Lichtenstein, G. R. ; Zakko, S. ; Gordon, G. L. ; Murthy, U. ; Sedghi, S. ; Pruitt, Ronald ; Merchant, K. ; Bortey, E. ; Forbes, W. P. / Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations : A pooled analysis from two randomised controlled trials. In: Alimentary Pharmacology and Therapeutics. 2012 ; Vol. 36, No. 2. pp. 126-134.
    @article{83b957d1194d4d6d92b909a36f7d92a4,
    title = "Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: A pooled analysis from two randomised controlled trials",
    abstract = "Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3{\%} vs. 58.8{\%}, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint). Conclusion Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. identifiers NCT00744016, NCT00767728.",
    author = "Lichtenstein, {G. R.} and S. Zakko and Gordon, {G. L.} and U. Murthy and S. Sedghi and Ronald Pruitt and K. Merchant and E. Bortey and Forbes, {W. P.}",
    year = "2012",
    month = "7",
    day = "1",
    doi = "10.1111/j.1365-2036.2012.05142.x",
    language = "English (US)",
    volume = "36",
    pages = "126--134",
    journal = "Alimentary Pharmacology and Therapeutics",
    issn = "0269-2813",
    publisher = "Wiley-Blackwell",
    number = "2",

    }

    TY - JOUR

    T1 - Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations

    T2 - A pooled analysis from two randomised controlled trials

    AU - Lichtenstein, G. R.

    AU - Zakko, S.

    AU - Gordon, G. L.

    AU - Murthy, U.

    AU - Sedghi, S.

    AU - Pruitt, Ronald

    AU - Merchant, K.

    AU - Bortey, E.

    AU - Forbes, W. P.

    PY - 2012/7/1

    Y1 - 2012/7/1

    N2 - Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint). Conclusion Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. identifiers NCT00744016, NCT00767728.

    AB - Background Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials. Aim To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations. Methods Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.5 g or placebo upon randomisation. The primary endpoint was the percentage of patients who remained relapse-free at Month 6 or end of treatment. Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare. Results Of the 487 patients who received 5-ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group. The percentage of patients who remained relapse-free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001). Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint). Conclusion Mesalazine granules 1.5 g once-daily is effective for maintenance of remission in UC patients who switch from other 5-ASA formulations. identifiers NCT00744016, NCT00767728.

    UR - http://www.scopus.com/inward/record.url?scp=84862531829&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=84862531829&partnerID=8YFLogxK

    U2 - 10.1111/j.1365-2036.2012.05142.x

    DO - 10.1111/j.1365-2036.2012.05142.x

    M3 - Article

    VL - 36

    SP - 126

    EP - 134

    JO - Alimentary Pharmacology and Therapeutics

    JF - Alimentary Pharmacology and Therapeutics

    SN - 0269-2813

    IS - 2

    ER -