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The efficacy of a 40‐mg extended‐release formulation of cisapride in the treatment of patients with gastro‐oesophageal reflux
Author(s) -
Katschinski,
Schirra,
Matthew D. Arnold
Publication year - 2000
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2000.00672.x
Subject(s) - cisapride , medicine , gastro , reflux , gastroenterology , disease
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.