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

Autor: D O, Castell, C, Sigmund, D, Patterson, R, Lambert, D, Hasner, C, Clyde, J B, Zeldis
Rok vydání: 1998
Předmět:
Zdroj: The American journal of gastroenterology. 93(4)
ISSN: 0002-9270
Popis: 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.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.Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p0.001), total regurgitation (p0.001), 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 (p0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p0.001); increasing the percentage of heartburn-free days and antacid-free nights (p0.5); 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.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.
Databáze: OpenAIRE