Safety of amisulpride (Solian (R)): a review of 11 clinical studies

We assessed the overall safety profile of amisulpride based on the results from 11 clinical studies performed in patients suffering from schizophrenia with predominance of positive or negative symptoms. A total of 1933 patien ts were randomly assigned to treatment with amisulpride (n = 1247) or halop eridol (n = 309), risperidone (n = 113), flupentixol (n = 62) and placebo ( n = 202). Safety data collection was performed using open reporting, UKU sc ales or specific extrapyramidal side effect scales; electrocardiogram recor ding and vital signs examination; laboratory data collection. Amisulpride d emonstrated a satisfactory global safety profile in the range of doses usua lly prescribed. The number of patients having at least one extrapyramidal s ide-effect was higher in haloperidol patients compared with both amisulprid e and risperidone patients (50% versus 30% in the two latter groups). For e ndocrine events, a similar rate was observed between amisulpride and risper idone groups (4% versus 6%, respectively) versus 1% in the haloperidol grou p. Electrocardiogram results were satisfactory, confirmed by the absence of cardiovascular events. The overall laboratory safety profile of amisulprid e did not show clinically relevant abnormalities in liver function tests no r haematological abnormalities. Our extensive clinical data confirm the sat isfactory safety profile of amisulpride which is superior to standard refer ence compounds. Int Clin Psychopharmacol 14:209-218 (C) 1999 Lippincott Wil liams & Wilkins.