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.

Englund A, Lawrie V, Lewander T, Schlachet A, Westerbergh S.-E. Safety evaluation in both short-and long-term treatment of schizophrenia with remoxipride. Acta Psychiatr Scand 1990; 82 (Supp1.358): 164-169.Abstract: Results for laboratory and cardiovascular variables in both shortterm (4-6 weeks) and long-term (>6 weeks) double-blind studies in schizophrenic patients consistently showed comparably low incidences of both transient treatment-emergent changes and changes present at last rating for both remoxipride and haloperidol.The total incidence of serious adverse events in the short-term double-blind programme was approximately 2% for both remoxipride and haloperidol. The corresponding figure for remoxipride (n=434) in long-term treatment was approximately 6%.Compared to those on haloperidol, fewer patients on remoxipride had trough plasma prolactin levels above the normal range in short-term treatment. The results with long-term treatment with remoxipride were similar. Breast swelling and galactorrhoea were infrequent treatment-emergent side effects with either drug. It was impossible to evaluate menstrual disturbance in short-term studies but in longterm use the incidence of treatment-emergent menstrual disorder was low in remoxipride patients. Too few patients continued treatment with haloperidol for a comparative long-term evaluation. Overall, based on the information available at present, remoxipride appears to offer a high degree of safety in I both short-term and long-term treatment of schizophrenia.Efficacy, tolerability, and safety together provide essential information on therapeutic suitability. The volume of safety data generated in a trial programme necessitates an analysis which aims to identify clinically significant drug effects clearly and quickly.Unfortunately, even with data as apparently objective as clinical chemistry and haematology, there is considerable variation in the range of values accepted as normal, both within, and between, different countries, largely due to different analytical methods. Similarly there are no universally accepted criteria of normality for cardiovascular variables.The remoxipride clinical programme described here comprised 9 short-term (4-6 weeks in duration) doubleblind comparative trials against haloperidol; long-term (> 6 weeks duration ) double-blind continuation studies; and both short-and long-term open studies. This trial programme required a large number of patients (1 143 on remoxipride and 487 on haloperidol) who met DSM-III criteria (1) for schizophrenia and this in turn necessitated an international research effort conducted in 1 1 countries over the past 7 years. Patients and methodsData on remoxipride are therefore available for 667 patients from short-term, double-blind studies in which haloperidol was the comparative agent (2); for 106 patients from double-blind continuation studies who continued on study medication double-blind at the end of the 4-6 week studies and therefore also appear in the short-term figures; and for 476 patients from open s...

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