COMPARISON OF 2 DOSING REGIMENS OF CISAPRIDE IN THE TREATMENT OF REFLUX ESOPHAGITIS

Aim: In an international, multicentre, double-blind trial, to document : the therapeutic equivalence of two dosing regimens of cisapride on e ndoscopic healing and symptom improvement in patients with proven refl ux oesophagitis grade I or II (Savary-Miller). Methods: Four hundred a nd seven patients were randomly allocated to treatment with either cis apride 10 mg q.d.s or cisapride 20 mg b.d. for 8-12 weeks depending on whether complete healing was found at endoscopy. The primary paramete rs of efficacy were cure of oesophagitis and improvement of the reflux symptom score. Results: The healing rates at endpoint were 73% in bot h treatment groups. The mean total reflux symptom score decreased from baseline to endpoint from 7.9-2.1 (cisapride 10 mg q.d.s.) and 7.9-2. 5 (cisapride 20 mg b.d.). Each of the two treatment regimens was well tolerated. The most frequently (6.9%) reported adverse event (diarrhoe a) was mild or moderate in most cases and can be explained by the phar macological action of cisapride. Conclusions: The results of the study demonstrate that cisapride 10 mg q.d.s. and 20 mg b.d. are equivalent in terms of efficacy and safety in the treatment of reflux oesophagit is.