Cisapride: a gastrointestinal prokinetic drug.

OBJECTIVE: To summarize the pharmacology, pharmacokinetics, efficacy, and safety of cisapride, and to evaluate its potential therapeutic role. DATA SOURCES: A computerized search of the MEDLINE database was used to identify English-language publications of cisapride data in humans. The MEDLINE search was supplemented by review article bibliographies. There was no attempt to limit the search to a specific gastrointestinal motility disorder. STUDY SELECTION: The MEDLINE search alone identified 165 citations. Because of the volume of available human cisapride data, the focus of the efficacy section is on complete published reports of controlled clinical studies. Abstracts and uncontrolled data are discussed only when other information is unavailable to address important aspects. DATA EXTRACTION: Information regarding study design, study population, results, and safety was recorded from each publication. The placebo response to gastrointestinal complaints in patients with motility disorders is high. Therefore, objective evidence of improvement was emphasized when documentation was available. DATA SYNTHESIS: Cisapride stimulates the motility of smooth muscle lining the esophagus, stomach, small intestine, and colon, and increases the tone of gut sphincters in vitro and in vivo. In controlled investigations, cisapride was superior to placebo in relieving symptoms associated with reflux esophagitis, nonulcer dyspepsia, and gastroparesis. Similar symptom and healing effects were observed with cisapride and histamine (H)2-antagonists in reflux esophagitis. Cisapride was either equal to or superior to metoclopramide in relieving reflux symptoms. However, metoclopramide was associated with significantly more central nervous system adverse effects. Cisapride was well tolerated, with adverse effects limited primarily to the gastrointestinal tract. CONCLUSIONS: Cisapride represents an attractive alternative to metoclopramide for the treatment of a variety of motility disorders. Because it addresses a primary underlying cause of reflux esophagitis, cisapride may also prove to be an effective alternative to acid suppressants in the management of this disorder.

Multicenter evaluation of ondansetron use in hospitalized oncology patients.

An evaluation of ondansetron use in oncology patients in three hospitals is described. Criteria for the use of ondansetron were developed and approved by each hospital's pharmacy and therapeutics committee or medical staff executive committee. Ondansetron use was concurrently monitored in adult inpatients for four months. Nursing and physician notes were reviewed, and the patients were interviewed. Data were collected on patient demographics, medical history, dosage of ondansetron, outcome, adverse effects, and concurrent medications. The approved criteria were used to evaluate the appropriateness, effectiveness, and safety of ondansetron therapy. A total of 262 oncology patients were evaluated. Of these, 223 (85%) received ondansetron appropriately based on the emetic potential of their antineoplastic drug regimen. Ondansetron was correctly prescribed for acute-phase prophylaxis of nausea and vomiting in 252 patients (96%). Only 117 (45%) of the patients met the criterion for appropriate dosage. The mean +/- S.D. dose of ondansetron was 11.7 +/- 3.22 mg, and the mean +/- S.D. number of doses received per patient was 4.4 +/- 3.23. Of the 135 patients who received an inappropriate dosage, 106 (79%) were given a dose larger than currently recommended by the manufacturer. Positive outcomes, defined as no more than two episodes of vomiting, no more than two episodes of retching, and no more than two p.r.n. doses of antiemetics, were observed in 97%, 99.6%, and 94% of the 248 patients included in the outcome analysis, respectively. Chemotherapy was completed on schedule in all the patients, and there were no complications due to excessive vomiting or retching. Adverse reactions were reported by 21 patients (8%).(ABSTRACT TRUNCATED AT 250 WORDS)