Clinical profile of remoxipride--a combined analysis of a comparative double-blind multicentre trial programme.

Nine double-blind studies comparing remoxipride to haloperidol in the treatment of acute schizophrenia formed the basis of this analysis. All studies followed a basic protocol with the main assessments performed regularly during the 4-6 week trial period according to the same methodology, thus allowing the data to be pooled. The results showed that remoxipride in a daily dose of 150-600 mg had a therapeutic effect comparable to that of haloperidol (5-45 mg/day), both on positive and negative symptoms. There was a clear advantage for remoxipride over haloperidol with regard to adverse events/symptoms, particularly extrapyramidal symptoms, but also drowsiness/somnolence and tiredness/fatigue. Anticholinergic drugs were used consistently less frequently as concomitant medication to alleviate extrapyramidal symptoms in the remoxipride group: the use of sedatives/hypnotics was approximately the same in both groups. Based on these and supportive clinical data, remoxipride seems to have a clinical profile characterized by antipsychotic efficacy in acute schizophrenia, apparently equal to that of haloperidol, and good tolerability in being non-sedative (in terms of drowsiness/somnolence) and with low incidences of extrapyramidal, autonomic, and endocrine symptoms.