Cisapride 20 mg b.i.d. Provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease

Donald O. Castell, Charles Sigmund, David Patterson, Rena Lambert, Diane Hasner, Chris Clyde, Jerome B. Zeldis, J. E. Geenen, Ronald Pruitt, S. Faruqui, J. L. Barnett, D. Fitch, F. L. Lanza, T. R. Liebermann, A. Ertan, M. Mellow, M. Berenson, M. DeMicco, R. B. Lasser, P. Karras & 4 others R. Shaker, W. Rosenthal, D. E. Merrell, M. S. Epstein

    Research output: Contribution to journalArticle

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    Abstract

    Objective: We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis. Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk. Results: Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p < 0.001); increasing the percentage of heartburn-free days and antacid-free nights (p < 0.5); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (p = 0.01). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group. Conclusion: Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.

    Original languageEnglish (US)
    Pages (from-to)547-552
    Number of pages6
    JournalAmerican Journal of Gastroenterology
    Volume93
    Issue number4
    DOIs
    StatePublished - Apr 1 1998

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    Cisapride
    Heartburn
    Gastroesophageal Reflux
    Antacids
    Placebos
    Eructation
    Esophagitis
    Diarrhea
    Safety
    Incidence

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology

    Cite this

    Cisapride 20 mg b.i.d. Provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. / Castell, Donald O.; Sigmund, Charles; Patterson, David; Lambert, Rena; Hasner, Diane; Clyde, Chris; Zeldis, Jerome B.; Geenen, J. E.; Pruitt, Ronald; Faruqui, S.; Barnett, J. L.; Fitch, D.; Lanza, F. L.; Liebermann, T. R.; Ertan, A.; Mellow, M.; Berenson, M.; DeMicco, M.; Lasser, R. B.; Karras, P.; Shaker, R.; Rosenthal, W.; Merrell, D. E.; Epstein, M. S.

    In: American Journal of Gastroenterology, Vol. 93, No. 4, 01.04.1998, p. 547-552.

    Research output: Contribution to journalArticle

    Castell, DO, Sigmund, C, Patterson, D, Lambert, R, Hasner, D, Clyde, C, Zeldis, JB, Geenen, JE, Pruitt, R, Faruqui, S, Barnett, JL, Fitch, D, Lanza, FL, Liebermann, TR, Ertan, A, Mellow, M, Berenson, M, DeMicco, M, Lasser, RB, Karras, P, Shaker, R, Rosenthal, W, Merrell, DE & Epstein, MS 1998, 'Cisapride 20 mg b.i.d. Provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease', American Journal of Gastroenterology, vol. 93, no. 4, pp. 547-552. https://doi.org/10.1111/j.1572-0241.1998.163_b.x
    Castell, Donald O. ; Sigmund, Charles ; Patterson, David ; Lambert, Rena ; Hasner, Diane ; Clyde, Chris ; Zeldis, Jerome B. ; Geenen, J. E. ; Pruitt, Ronald ; Faruqui, S. ; Barnett, J. L. ; Fitch, D. ; Lanza, F. L. ; Liebermann, T. R. ; Ertan, A. ; Mellow, M. ; Berenson, M. ; DeMicco, M. ; Lasser, R. B. ; Karras, P. ; Shaker, R. ; Rosenthal, W. ; Merrell, D. E. ; Epstein, M. S. / Cisapride 20 mg b.i.d. Provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. In: American Journal of Gastroenterology. 1998 ; Vol. 93, No. 4. pp. 547-552.
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    abstract = "Objective: We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis. Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk. Results: Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p < 0.001); increasing the percentage of heartburn-free days and antacid-free nights (p < 0.5); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (p = 0.01). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10{\%} of patients, compared with an incidence of 4{\%} in the placebo group. Conclusion: Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.",
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    T1 - Cisapride 20 mg b.i.d. Provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease

    AU - Castell, Donald O.

    AU - Sigmund, Charles

    AU - Patterson, David

    AU - Lambert, Rena

    AU - Hasner, Diane

    AU - Clyde, Chris

    AU - Zeldis, Jerome B.

    AU - Geenen, J. E.

    AU - Pruitt, Ronald

    AU - Faruqui, S.

    AU - Barnett, J. L.

    AU - Fitch, D.

    AU - Lanza, F. L.

    AU - Liebermann, T. R.

    AU - Ertan, A.

    AU - Mellow, M.

    AU - Berenson, M.

    AU - DeMicco, M.

    AU - Lasser, R. B.

    AU - Karras, P.

    AU - Shaker, R.

    AU - Rosenthal, W.

    AU - Merrell, D. E.

    AU - Epstein, M. S.

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    Y1 - 1998/4/1

    N2 - Objective: We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis. Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk. Results: Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p < 0.001); increasing the percentage of heartburn-free days and antacid-free nights (p < 0.5); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (p = 0.01). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group. Conclusion: Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.

    AB - Objective: We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis. Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk. Results: Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p < 0.001); increasing the percentage of heartburn-free days and antacid-free nights (p < 0.5); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (p = 0.01). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group. Conclusion: Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.

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