[Efficacy and tolerability of cisapride in a new formula of 10 mg effervescent capsules for the treatment of functional dyspepsia].
The efficacy and tolerability of Cisapride effervescent granules and a metoclopramide-dimethicone combination were compared double-blind in two comparable groups of 15 patients each with dyspepsia. All patients received three sachets daily of either drug for 6 consecutive weeks. As for efficacy, Cisapride effervescent granules was found to reduce 85% (11/13) of symptoms to a statistically significant extent, as against 42% (5/12) in the reference group. Statistical analysis showed Cisapride effervescent granules to be more effective than the reference drug for 6 out of 11 evaluable symptoms. Mean global improvement was 86% for Cisapride effervescent granules vs 41% for the reference combination. Final judgment by the physician was more favorable for Cisapride effervescent granules than for the reference drug (p < 0.0001). Treatment withdrawal was never necessary and no significant changes of laboratory values were observed. No statistically significant difference between the two treatments as to tolerability was observed. In conclusion, Cisapride effervescent granules was found to have a better risk/benefit ratio than the reference combination.
Grossi
L
L
Istituto di Patologia Speciale Medica e Metodologia Clinica, Università degli Studi di Chieti.
Di Felice
F
F
Marzio
L
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002214:Capsules; D020117:Cisapride; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D005772:Gastrointestinal Transit / Q000187:drug effects; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage*; D012307:Risk Factors; D012841:Simethicone / Q000008:administration & dosage
D002214:Capsules; D010880:Piperidines; D012841:Simethicone; D008787:Metoclopramide; D020117:Cisapride
Efficacia e tollerabilità di una nuova formulazione di cisapride, granulato effervescente 10 mg, nel trattamento della dispepsia funzionale.