Once-daily mesalamine granules for maintaining remission of ulcerative colitis

Pooled analysis of efficacy, safety, and prognostic factors

Salam F. Zakko, Glenn L. Gordon, Uma Murthy, Shahriar Sedghi, Ronald Pruitt, Andrew C. Barrett, Enoch Bortey, Craig Paterson, William P. Forbes, Gary R. Lichtenstein

    Research output: Contribution to journalArticle

    3 Citations (Scopus)

    Abstract

    Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC–related adverse event (AE). Results: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.

    Original languageEnglish (US)
    Pages (from-to)273-281
    Number of pages9
    JournalPostgraduate medicine
    Volume128
    Issue number3
    DOIs
    StatePublished - Jan 1 2016

    Fingerprint

    Mesalamine
    Ulcerative Colitis
    Safety
    Placebos
    Recurrence
    Hemorrhage
    Abdominal Pain
    Compliance
    Capsules
    Headache
    Diarrhea
    Demography
    Outcome Assessment (Health Care)
    Physicians

    All Science Journal Classification (ASJC) codes

    • Medicine(all)

    Cite this

    Once-daily mesalamine granules for maintaining remission of ulcerative colitis : Pooled analysis of efficacy, safety, and prognostic factors. / Zakko, Salam F.; Gordon, Glenn L.; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ronald; Barrett, Andrew C.; Bortey, Enoch; Paterson, Craig; Forbes, William P.; Lichtenstein, Gary R.

    In: Postgraduate medicine, Vol. 128, No. 3, 01.01.2016, p. 273-281.

    Research output: Contribution to journalArticle

    Zakko, SF, Gordon, GL, Murthy, U, Sedghi, S, Pruitt, R, Barrett, AC, Bortey, E, Paterson, C, Forbes, WP & Lichtenstein, GR 2016, 'Once-daily mesalamine granules for maintaining remission of ulcerative colitis: Pooled analysis of efficacy, safety, and prognostic factors', Postgraduate medicine, vol. 128, no. 3, pp. 273-281. https://doi.org/10.1080/00325481.2016.1152876
    Zakko, Salam F. ; Gordon, Glenn L. ; Murthy, Uma ; Sedghi, Shahriar ; Pruitt, Ronald ; Barrett, Andrew C. ; Bortey, Enoch ; Paterson, Craig ; Forbes, William P. ; Lichtenstein, Gary R. / Once-daily mesalamine granules for maintaining remission of ulcerative colitis : Pooled analysis of efficacy, safety, and prognostic factors. In: Postgraduate medicine. 2016 ; Vol. 128, No. 3. pp. 273-281.
    @article{49f7d60589c04b96991515cadc26793d,
    title = "Once-daily mesalamine granules for maintaining remission of ulcerative colitis: Pooled analysis of efficacy, safety, and prognostic factors",
    abstract = "Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC–related adverse event (AE). Results: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4{\%}) than placebo (62.4{\%}; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9{\%} and 7.6{\%}), diarrhea (7.9{\%} and 7.0{\%}), and abdominal pain (6.3{\%} and 6.5{\%}). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.",
    author = "Zakko, {Salam F.} and Gordon, {Glenn L.} and Uma Murthy and Shahriar Sedghi and Ronald Pruitt and Barrett, {Andrew C.} and Enoch Bortey and Craig Paterson and Forbes, {William P.} and Lichtenstein, {Gary R.}",
    year = "2016",
    month = "1",
    day = "1",
    doi = "10.1080/00325481.2016.1152876",
    language = "English (US)",
    volume = "128",
    pages = "273--281",
    journal = "Postgraduate Medicine",
    issn = "0032-5481",
    publisher = "Medquest Communications LLC",
    number = "3",

    }

    TY - JOUR

    T1 - Once-daily mesalamine granules for maintaining remission of ulcerative colitis

    T2 - Pooled analysis of efficacy, safety, and prognostic factors

    AU - Zakko, Salam F.

    AU - Gordon, Glenn L.

    AU - Murthy, Uma

    AU - Sedghi, Shahriar

    AU - Pruitt, Ronald

    AU - Barrett, Andrew C.

    AU - Bortey, Enoch

    AU - Paterson, Craig

    AU - Forbes, William P.

    AU - Lichtenstein, Gary R.

    PY - 2016/1/1

    Y1 - 2016/1/1

    N2 - Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC–related adverse event (AE). Results: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.

    AB - Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC–related adverse event (AE). Results: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.

    UR - http://www.scopus.com/inward/record.url?scp=84964033245&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=84964033245&partnerID=8YFLogxK

    U2 - 10.1080/00325481.2016.1152876

    DO - 10.1080/00325481.2016.1152876

    M3 - Article

    VL - 128

    SP - 273

    EP - 281

    JO - Postgraduate Medicine

    JF - Postgraduate Medicine

    SN - 0032-5481

    IS - 3

    ER -