Safety evaluation in both short- and long-term treatment of schizophrenia with remoxipride.

Results for laboratory and cardiovascular variables in both short-term (4-6 weeks) and long-term (greater than 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 long-term 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 both short-term and long-term treatment of schizophrenia.