CISAPRIDE 20 MG BID PROVIDES SYMPTOMATIC RELIEF OF HEARTBURN AND RELATED SYMPTOMS OF CHRONIC MILD-TO-MODERATE GASTROESOPHAGEAL REFLUX DISEASE

Objective: We evaluated the efficacy and safety of a twice-daily dosag e regimen of cisapride 20 mg in relieving the symptoms of mild-moderat e gastroesophageal reflux disease (GERD) in patients with moderate int ensity heartburn and no history of erosive esophagitis, Methods: After a 2-wk, single-blind, placebo run-in period, 398 patients who continu ed to experience moderate intensity heartburn were randomized to eithe r placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk, Results: Compared with placebo, cisapride significantly reduced store s for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04), Cis apride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance an alyses, daytime and nighttime heartburn with antacid usage (p < 0.001) ; increasing the percentage of heartburn-free days and antacid-free ni ghts (p < 0.5); and increasing the percentage of patients self-rated a s having minimal or better symptomatic improvement (p = 0.01), Cisapri de 20 mg b.i.d. was well tolerated. The most common adverse event in t he cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group. Conclusion: Cisapride 2 0 mg b.i.d. was shown to be effective and safe for the short-term trea tment of daytime and nighttime heartburn and for other symptoms associ ated with mild-moderate GERD. (C) 1998 by Am. Coll. of Gastroenterolog y.