Esophagus: Twenty milligrams oral cisapride given once to healthy volunteers increased LESP, starting 45 minutes after dosing, with a peak response at 75 minutes. The full duration of the effect was not monitored, and doses smaller than 20 mg were ineffective. Ten milligrams oral cisapride, administered 3 times daily for several days to patients with GERD, resulted in a significant increase in LESP, and an increased esophageal acid clearance.

Stomach: Cisapride (single 10 mg doses or 10 mg given orally 3 times daily up to 6 weeks) significantly accelerated gastric emptying of both liquids and solids. Acceleration of gastric emptying, measured over a 4 hour period following a radio-labeled test meal given at lunch time, was greatest when 10 mg cisapride was given both in the morning and again before the test meal, intermediate when 20 mg was given as a single administration in the morning and least when only 10 mg was given on the morning of the test meal. The increases in gastric emptying were proportional to the plasma levels of cisapride measured in these subjects over the same 4 hours that the gastric emptying test was conducted.

CLINICAL STUDIES

Clinical trials have shown that cisapride can reduce the severity of symptoms of nocturnal heartburn associated with gastroesophageal reflux disease. Two placebo-controlled studies, one using a dose of 10 mg qid, the other both 10 and 20 mg qid, showed effects on nighttime heartburn, although the 10 mg dose in the second study was only marginally effective. There were no consistent effects on daytime heartburn, symptoms of regurgitation, or histopathology of the esophagus. Use of antacids was only infrequently affected and slightly decreased. In a third controlled trial of similar design to the others, neither 10 mg nor 20 mg taken 4 times daily was superior to placebo. In these clinical trials cisapride did not wshow a significant effect on LESP.

In a clinical trial comparing 10 mg cisapride to placebo, pH probe evaluation, in a relatively small number of patients, did not reveal a significant difference in pH.

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