Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis

A multicenter study

C. A. Sninsky, D. H. Cort, F. Shanahan, B. J. Powers, J. T. Sessions, R. E. Pruitt, W. H. Jacobs, S. K. Lo, S. R. Targan, J. J. Cerda, D. E. Gremillion, W. J. Snape, J. Sabel, H. Jinich, J. M. Swinehart, M. P. DeMicco

    Research output: Contribution to journalArticle

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    Abstract

    Objective: To evaluate the efficacy and safety of a pH-sensitive, polymer-coated oral preparation of mesalamine in patients with mildly to moderately active ulcerative colitis. Design: A multicenter, double-blind, placebo-controlled randomized trial. Setting: Five university-based medical centers, one inflammatory bowel disease center, and three private practice sites. Patients: A total of 158 patients with newly or previously diagnosed active ulcerative colitis. Intervention: A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks. Measurements: Efficacy was measured by scores for stool frequency, rectal bleeding, patient's functional assessment, sigmoidoscopic findings, and physician's global assessment. Stringent criteria for disease activity were established prospectively. Results: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with patients taking placebo (32% versus 9%; P = 0.003). At 6 weeks, both the 1.6 g/d (43%) and 2.4 g/d (49%) doses were significantly superior to placebo (23%) (P = 0.03 and P = 0.003, respectively). In addition, more patients worsened in the placebo group compared with the 2.4 g/d group (50% versus 19%; P = 0.003); however, there was no statistically significant difference in worsening between the 1.6 g/d mesalamine group and the placebo group. The oral mesalamine tablet was well tolerated, and no clinically significant changes were observed in hematologic, hepatic, or renal laboratory profiles. Conclusion: Colon-targeted oral mesalamine at 2.4 g/d is effective therapy for mildly to moderately active ulcerative colitis. It is well tolerated and should provide a viable therapeutic alternative to sulfasalazine.

    Original languageEnglish (US)
    Pages (from-to)350-355
    Number of pages6
    JournalAnnals of Internal Medicine
    Volume115
    Issue number5
    DOIs
    StatePublished - Jan 1 1991

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    Mesalamine
    Ulcerative Colitis
    Multicenter Studies
    Placebos
    Polymers
    Sulfasalazine
    Private Practice
    Inflammatory Bowel Diseases
    Tablets
    Colon
    Randomized Controlled Trials
    Hemorrhage
    Physicians
    Kidney
    Safety
    Liver
    Therapeutics

    All Science Journal Classification (ASJC) codes

    • Internal Medicine

    Cite this

    Sninsky, C. A., Cort, D. H., Shanahan, F., Powers, B. J., Sessions, J. T., Pruitt, R. E., ... DeMicco, M. P. (1991). Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis: A multicenter study. Annals of Internal Medicine, 115(5), 350-355. https://doi.org/10.7326/0003-4819-115-5-350

    Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis : A multicenter study. / Sninsky, C. A.; Cort, D. H.; Shanahan, F.; Powers, B. J.; Sessions, J. T.; Pruitt, R. E.; Jacobs, W. H.; Lo, S. K.; Targan, S. R.; Cerda, J. J.; Gremillion, D. E.; Snape, W. J.; Sabel, J.; Jinich, H.; Swinehart, J. M.; DeMicco, M. P.

    In: Annals of Internal Medicine, Vol. 115, No. 5, 01.01.1991, p. 350-355.

    Research output: Contribution to journalArticle

    Sninsky, CA, Cort, DH, Shanahan, F, Powers, BJ, Sessions, JT, Pruitt, RE, Jacobs, WH, Lo, SK, Targan, SR, Cerda, JJ, Gremillion, DE, Snape, WJ, Sabel, J, Jinich, H, Swinehart, JM & DeMicco, MP 1991, 'Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis: A multicenter study', Annals of Internal Medicine, vol. 115, no. 5, pp. 350-355. https://doi.org/10.7326/0003-4819-115-5-350
    Sninsky, C. A. ; Cort, D. H. ; Shanahan, F. ; Powers, B. J. ; Sessions, J. T. ; Pruitt, R. E. ; Jacobs, W. H. ; Lo, S. K. ; Targan, S. R. ; Cerda, J. J. ; Gremillion, D. E. ; Snape, W. J. ; Sabel, J. ; Jinich, H. ; Swinehart, J. M. ; DeMicco, M. P. / Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis : A multicenter study. In: Annals of Internal Medicine. 1991 ; Vol. 115, No. 5. pp. 350-355.
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    abstract = "Objective: To evaluate the efficacy and safety of a pH-sensitive, polymer-coated oral preparation of mesalamine in patients with mildly to moderately active ulcerative colitis. Design: A multicenter, double-blind, placebo-controlled randomized trial. Setting: Five university-based medical centers, one inflammatory bowel disease center, and three private practice sites. Patients: A total of 158 patients with newly or previously diagnosed active ulcerative colitis. Intervention: A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks. Measurements: Efficacy was measured by scores for stool frequency, rectal bleeding, patient's functional assessment, sigmoidoscopic findings, and physician's global assessment. Stringent criteria for disease activity were established prospectively. Results: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with patients taking placebo (32{\%} versus 9{\%}; P = 0.003). At 6 weeks, both the 1.6 g/d (43{\%}) and 2.4 g/d (49{\%}) doses were significantly superior to placebo (23{\%}) (P = 0.03 and P = 0.003, respectively). In addition, more patients worsened in the placebo group compared with the 2.4 g/d group (50{\%} versus 19{\%}; P = 0.003); however, there was no statistically significant difference in worsening between the 1.6 g/d mesalamine group and the placebo group. The oral mesalamine tablet was well tolerated, and no clinically significant changes were observed in hematologic, hepatic, or renal laboratory profiles. Conclusion: Colon-targeted oral mesalamine at 2.4 g/d is effective therapy for mildly to moderately active ulcerative colitis. It is well tolerated and should provide a viable therapeutic alternative to sulfasalazine.",
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    T1 - Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis

    T2 - A multicenter study

    AU - Sninsky, C. A.

    AU - Cort, D. H.

    AU - Shanahan, F.

    AU - Powers, B. J.

    AU - Sessions, J. T.

    AU - Pruitt, R. E.

    AU - Jacobs, W. H.

    AU - Lo, S. K.

    AU - Targan, S. R.

    AU - Cerda, J. J.

    AU - Gremillion, D. E.

    AU - Snape, W. J.

    AU - Sabel, J.

    AU - Jinich, H.

    AU - Swinehart, J. M.

    AU - DeMicco, M. P.

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    N2 - Objective: To evaluate the efficacy and safety of a pH-sensitive, polymer-coated oral preparation of mesalamine in patients with mildly to moderately active ulcerative colitis. Design: A multicenter, double-blind, placebo-controlled randomized trial. Setting: Five university-based medical centers, one inflammatory bowel disease center, and three private practice sites. Patients: A total of 158 patients with newly or previously diagnosed active ulcerative colitis. Intervention: A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks. Measurements: Efficacy was measured by scores for stool frequency, rectal bleeding, patient's functional assessment, sigmoidoscopic findings, and physician's global assessment. Stringent criteria for disease activity were established prospectively. Results: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with patients taking placebo (32% versus 9%; P = 0.003). At 6 weeks, both the 1.6 g/d (43%) and 2.4 g/d (49%) doses were significantly superior to placebo (23%) (P = 0.03 and P = 0.003, respectively). In addition, more patients worsened in the placebo group compared with the 2.4 g/d group (50% versus 19%; P = 0.003); however, there was no statistically significant difference in worsening between the 1.6 g/d mesalamine group and the placebo group. The oral mesalamine tablet was well tolerated, and no clinically significant changes were observed in hematologic, hepatic, or renal laboratory profiles. Conclusion: Colon-targeted oral mesalamine at 2.4 g/d is effective therapy for mildly to moderately active ulcerative colitis. It is well tolerated and should provide a viable therapeutic alternative to sulfasalazine.

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