Cisapride is structurally similar to metoclopramide, but has no dopamine receptor antagonist activity and hence no central antiemetic effect. However, because it stimulates the release of acetylcholine in the gastrointestinal tract it is effective in conditions such as reflux esophagitis and gastroparesis. During clinical trials, the most frequent unwanted effects were diarrhea (5-11%) and abdominal pain (16% with 20 mg bd).
The effect of cisapride 20 mg bd for 7 days in preventing symptoms of gastro-esophageal reflux disease induced by a provocative meal has been assessed in 122 patients who had had symptoms suggestive of gastro-esophageal reflux for at least 3 months (1). Cisapride prevented or reduced the symptoms of heartburn and related symptoms, such as belching and regurgitation. Mild to moderate diarrhea was the main adverse effect.
In a randomized, double-blind study in 106 patients with non-ulcer dyspepsia, cinitapride 1 mg tds was as effective as cisapride 5 mg tds in relieving symptoms (2). Adverse events, mainly gastrointestinal, were transient and did not require drug withdrawal. In another randomized study in 28 children (aged 5-17 years) with diabetic gastroparesis, domperidone 0.9 mg/kg/day for 8 weeks was superior to cisapride 0.8 mg/kg/day in reversing gastric emptying delay and gastric electrical abnormalities, as well as in improving dyspeptic symptoms and diabetic control (3). No potentially drug-related adverse effects were reported.
The effect of cisapride 10 mg qds for 5 days on the frequency of nocturnal transient lower esophageal sphincter relaxation and esophageal acid exposure has been studied in a double-blind, placebo-controlled, crossover study in 10 patients with gastro-esophageal reflux disease (4). Cisapride significantly reduced the frequency of transient lower esophageal sphincter relaxation during sleep and increased lower esophageal sphincter pressure without changing gastric emptying. However, in a larger doubleblind, placebo-controlled, crossover study in 30 patients with gastro-esophageal reflux disease, cisapride 20 mg bd for 4 weeks (despite adequate plasma concentrations) had no significant effects on swallow-induced esophageal peristaltic activity, the basal tone of the lower esophageal sphincter, or the number of transient lower esophageal sphincter relaxations induced by gas distension of the stomach (5). Adverse effects were similar in the two treatment sequences, although there were a few more episodes of abdominal cramps, nausea, and headache with cisapride.
A comparison of data from prescription event monitoring in over 13 000 recipients of cisapride and from a further 9726 recipients involved in a controlled study showed that diarrhea, in about 2-4% of patients, was the commonest adverse effect reported. Other relatively common adverse effects are headache, abdominal pain, nausea and vomiting, and constipation, all in about 1-1.5% of patients.
A thorough review of the effects of cisapride in patients in intensive care suggested that adverse reactions are not likely to be severe or problematical (6). However, cisapride has been withdrawn because of the risk of prolongation of the QT interval and consequent ventricular dysrhythmias.
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Gastroesophageal reflux disease is the medical term for what we know as acid reflux. Acid reflux occurs when the stomach releases its liquid back into the esophagus, causing inflammation and damage to the esophageal lining. The regurgitated acid most often consists of a few compoundsbr acid, bile, and pepsin.