Safety profile of amisulpride in short- and long-term use.
OBJECTIVE
To assess the safety of the new atypical antipsychotic drug, amisulpride, in short- and long-term use.


METHODS
Studies comparing the safety of amisulpride with that of haloperidol and risperidone, respectively, are reviewed. Safety was monitored by open adverse event reporting, the Simpson-Angus Scale, the Barnes Akathisia Scale and the Abnormal Involuntary Movement scale.


RESULTS
In short- and long-term studies, amisulpride induced significantly less EPS and akathisia than haloperidol. Safety ratings were similar to risperidone in short-term studies. In studies of chronic schizophrenia with predominant negative symptoms, amisulpride was similar to placebo. Endocrine effects were similar in amisulpride-, haloperidol- and risperidone-treated patients. Weight gain with amisulpride was significantly less than risperidone in a short-term study. No clinically important effects on haematological, hepatic or cardiac function were recorded. Data obtained in short- and long-term studies have been confirmed in extensive post-marketing surveillance data.


CONCLUSIONS
Amisulpride has a broad spectrum of efficacy in schizophrenia without introducing the iatrogenic consequences associated with older therapies.
Rein
W
W
Snofi Sythélabo, Bagneux, France.
Coulouvrat
C
C
Dondey-Nouvel
L
L
D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D013469:Sulpiride / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride; D006220:Haloperidol; D018967:Risperidone