Risk factors, co-medication, and concomitant diseases: their influence on the outcome of therapy with cisapride

In a 28-day non-blinded study of 1071 patients with functional dyspeptic symptoms in a general practice setting, 666 presented with mainly typical symptoms of functional dyspepsia and received 5 mg cisapride three times daily, while 405 with predominating symptoms indicative of gastroesophageal reflux received 10 mg cisapride three times daily. On the basis of an anamnestic risk factor analysis for organic lesions, 'low-risk' patients were to be treated directly with cisapride, while for 'high-risk' patients a more thorough gastrointestinal examination was recommended before starting cisapride. Of patients in the dyspepsia group 75% reported a good or excellent response; the corresponding rate was 80% in the reflux group. Low-risk patients in both groups tended to respond better than high-risk patients (mean difference, 11%). Patients and investigators reached identical assessments of response. Concomitant antacids, calcium antagonists, beta-blockers and sedatives did not affect the results, but concomitant NSAIDs reduced the mean improvement rate by 14% (p < 0.01). Adverse effects such as abdominal cramps and loose stools were uncommon (< or = 3.4%).