Factors affecting short- and long-term outcome of a short therapeutic trial with cisapride in dyspeptic patients.
In a Dutch general practice trial conducted in 599 patients with symptoms of dyspepsia, the response to 5 mg cisapride three times daily was rated excellent or good in 61% of patients at week 2. On increasing the dose to 10 mg three times daily in 132 patients with poor to moderate response, the result at the end of treatment was rated as good or excellent in 45% of these patients, and the mean symptom score further decreased significantly (p < 0.05). The longer the pretreatment duration of dyspeptic symptoms, the lower was the overall response rate to cisapride short-term therapy (80% in patients with complaints < 3 months versus 50% in those with complaints > 4 years). Cisapride also proved effective in patients previously treated with prokinetic agents (72% response rate), antacids (66%) and H2-receptor antagonists (48%). On long-term follow-up, dyspepsia relapse rates among the total patient population (n = 357) and the patient sample fully 'cured' after 4 weeks of cisapride (n = 226) were respectively 30% and 27% after 6 months. Factors affecting recurrence of dyspeptic symptoms included age, duration of symptoms prior to trial entry and mean symptom score at end of the treatment study, but not the symptom severity prior to treatment. Relapsing patients presented mainly with the same symptom profile as at the first study, and the majority (88%) responded well to repeated treatment with cisapride. In conclusion, most patients responded well to a short therapeutic trial with cisapride and remained free from relapse in the subsequent 6 months. Repeated treatment in patients with recurrent symptoms appeared to be successful.
Clinical Research Dept. Janssen Pharmaceutica, Tilburg, The Netherlands.
P M
PM
Heyse
R
R
Rambaldo
B
B
Hazelhoff
D000328:Adult; D000367:Age Factors; D000368:Aged; D020117:Cisapride; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005769:Gastrointestinal Motility / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D012008:Recurrence; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D010880:Piperidines; D020117:Cisapride