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.
Morrison
D
D
Astra Research Centre, Södertälje, Sweden.
Englund
A
A
Lawrie
V
V
Lewander
T
T
Schlachet
A
A
Westerbergh
S E
SE
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001480:Basal Ganglia Diseases / Q000209:etiology; D001549:Benzamides / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D062787:Drug Overdose / Q000401:mortality; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008134:Long-Term Care; D008297:Male; D011388:Prolactin / Q000097:blood; D011569:Psychiatric Status Rating Scales; D017330:Remoxipride; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology
D014150:Antipsychotic Agents; D001549:Benzamides; D017330:Remoxipride; D011388:Prolactin; D006220:Haloperidol