The efficacy of a 40-mg extended-release formulation of cisapride in the treatment of patients with gastro-oesophageal reflux

Abstract

Background: This study was conducted to assess the efficacy of a novel 40-mg extended-release formulation of cisapride in reducing gastro-oesophageal reflux.

Methods: According to a double-blind, randomized, placebo-controlled design, 19 patients with pathological gastro-oesophageal reflux were treated with extended (40 mg o.d.) or immediate (10 mg q.d.s.) release formulations for two periods of 4 days each (pH-monitoring on day four). Patients received identical treatments in both periods to allow limits of agreement defining equivalent potency of both formulations to be derived from intra-individual variability of treatment effects.

Results: The extended-release formulation decreased total and upright reflux times by 5.5 +/- 1.3% and 8.1 +/- 2.1% (P < 0.001), respectively. It did not change the percentage supine reflux time but diminished the mean duration of reflux episodes by 1.0 +/- 0.4 min (P=0.005). The total number of reflux episodes remained unaltered with both formulations. Immediately-released cisapride decreased total, upright, and supine acid exposures by 5.8 +/- 1.3%, 6.8 +/- 1.6% (P < 0.002) and 3.6 +/- 1.8%, respectively, and mean duration of episodes by 0.9 +/- 0.2 min (P </= 0.05). Equivalent potency for both formulations was accepted in terms of percentage total and upright acid exposure and mean duration of episodes.

Conclusions: The 40-mg extended-release formulation of cisapride decreases total acid exposure and in this study is equivalent to the conventional immediate-release 10 mg q.d.s. regimen. Cisapride primarily interferes with reflux by improving oesophageal acid clearance.