[A new granular effervescent 10-mg formulation of cisapride in the treatment of gastroesophageal reflux].
The efficacy and tolerability of Cisapride effervescent granules for treatment of gastroesophageal reflux disease were compared to a metoclopramide-dimeticone combination. The double-blind study was performed in two groups of 10 patients each who received 3 sachets daily of either drug for 8 weeks. Cisapride effervescent granules induced a statistically significant improvement of 75% of symptoms (6/8) while this improvement was obtained with the reference drug for only 60% (3/5). Statistical evaluation showed Cisapride effervescent granules to be more effective than the reference drug for 2 of 5 evaluable symptoms; mean global improvement amounted to 83 vs 58%. Final physician opinion was more favorable to Cisapride effervescent granules than to the reference drug (p < 0.005). Treatment did not have to be withdrawn nor were clinically significant changes of laboratory values observed. Both drugs were found to be well tolerated without differences between the two groups. Three patients treated with Cisapride effervescent granules complained of short-lasting mild abdominal discomfort the relations of which to the drug was doubtful, and which subsided spontaneously without need to withdraw treatment or to apply other types of therapy.
Grossi
L
L
Istituto di Patologia Speciale Medica e Metodologica Clinica, Università degli Studi di Chieti.
Di Felice
F
F
Marzio
L
L
D000328:Adult; D000368:Aged; D020117:Cisapride; D004311:Double-Blind Method; D004338:Drug Combinations; D004361:Drug Tolerance; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000627:therapeutic use; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage*; D011208:Powders; D012702:Serotonin Antagonists / Q000008:administration & dosage*; D012841:Simethicone / Q000627:therapeutic use; D013997:Time Factors
D004338:Drug Combinations; D010880:Piperidines; D011208:Powders; D012702:Serotonin Antagonists; D012841:Simethicone; D008787:Metoclopramide; D020117:Cisapride
Una nuova formulazione di cisapride, granulato effervescente 10 mg, nel trattamento della malattia da reflusso gastroesofageo.