R. Corinaldesi et al., THE EFFECT OF DIFFERENT DOSAGE SCHEDULES OF CISAPRIDE ON GASTRIC-EMPTYING IN IDIOPATHIC GASTROPARESIS, European Journal of Clinical Pharmacology, 44(5), 1993, pp. 429-432
The aim of this study was to determine the optimal dosage regimen of c
isapride for the treatment of idiopathic gastroparesis. We studied 17
patients with documented idiopathic gastroparesis in a three-way, cros
s-over, double-blind study with three 4-day treatment periods separate
d by at least 3 days without treatment. In each period. the patients w
ere preloaded with cisapride (10 mg tid) for three days. On cake fourt
h day (the test day) they took either 10 mg or 20 mg before breakfast
and placebo before lunch (I x 10 mg), (I x 20 mg), or to mg before bre
akfast and 10 mg before lunch (2 x 10 mg). The medications were taken
30 min before meals. Gastric emptying of solids (Tc-99m-sulphur colloi
d) was measured at lunch time under basal conditions and during each t
reatment period. Plasma concentrations of cisapride were determined be
fore the breakfast dose, before cake lunch dose, and at 1, 2, 3, 4 and
5 h after. The greatest acceleration in gastric emptying occurred wit
h the 2 x 10 mg regimen. Although cake single morning dose of 20 mg al
so significantly accelerated gastric emptying (P = 0.05), the reductio
n was not as substantial. Plasma concentrations of cisapride were sign
ificantly higher after 2 x 10 mg than after 1 x 20 mg or 1 x 10 mg. Th
ere was a significant relation between cisapride plasma concentrations
and changes in gastric emptying. Peak concentrations of cisapride gre
ater than 60 ng . ml-1 were invariably associated with acceleration of
gastric emptying. We conclude that cisapride 10 mg tid before meals i
s the optimal dose for the treatment of idiopathic gastroparesis.