Cisapride 20 mg b.i.d. 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 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.