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Cisapride 20 mg b.i.d. provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. CIS-USA-52 Investigator Group.
Am J Gastroenterol. 1998 Apr; 93(4):547-52.AJ

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.

Authors+Show Affiliations

Allegheny University Hospitals, Philadelphia, Pennsylvania 19146, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9576446

Citation

Castell, D O., et al. "Cisapride 20 Mg B.i.d. Provides Symptomatic Relief of Heartburn and Related Symptoms of Chronic Mild to Moderate Gastroesophageal Reflux Disease. CIS-USA-52 Investigator Group." The American Journal of Gastroenterology, vol. 93, no. 4, 1998, pp. 547-52.
Castell DO, Sigmund C, Patterson D, et al. Cisapride 20 mg b.i.d. provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. CIS-USA-52 Investigator Group. Am J Gastroenterol. 1998;93(4):547-52.
Castell, D. O., Sigmund, C., Patterson, D., Lambert, R., Hasner, D., Clyde, C., & Zeldis, J. B. (1998). Cisapride 20 mg b.i.d. provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. CIS-USA-52 Investigator Group. The American Journal of Gastroenterology, 93(4), 547-52.
Castell DO, et al. Cisapride 20 Mg B.i.d. Provides Symptomatic Relief of Heartburn and Related Symptoms of Chronic Mild to Moderate Gastroesophageal Reflux Disease. CIS-USA-52 Investigator Group. Am J Gastroenterol. 1998;93(4):547-52. PubMed PMID: 9576446.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cisapride 20 mg b.i.d. provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease. CIS-USA-52 Investigator Group. AU - Castell,D O, AU - Sigmund,C,Jr AU - Patterson,D, AU - Lambert,R, AU - Hasner,D, AU - Clyde,C, AU - Zeldis,J B, PY - 1998/5/12/pubmed PY - 2001/3/28/medline PY - 1998/5/12/entrez SP - 547 EP - 52 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 93 IS - 4 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. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/9576446/Cisapride_20_mg_b_i_d__provides_symptomatic_relief_of_heartburn_and_related_symptoms_of_chronic_mild_to_moderate_gastroesophageal_reflux_disease__CIS_USA_52_Investigator_Group_ L2 - http://Insights.ovid.com/pubmed?pmid=9576446 DB - PRIME DP - Unbound Medicine ER -