[Safety and tolerability of olanzapine versus risperidone: a one-year randomized study in outpatients with schizophrenia with prominent negative symptoms].
OBJECTIVE
To evaluate the safety and tolerability of long-term treatment with olanzapine versus risperidone in schizophrenic outpatients with prominent negative symptoms.


METHODS
This was a multi-center, randomised, open-label, parallel, dose-flexible, 1 year study of outpatients with schizophrenia (DSM-IV criteria) with prominent negative symptoms (SANS Global score > or =10). Safety was evaluated by recording treatment-emergent adverse events, vital signs, body weight and, when available, laboratory parameters. Extrapyramidal symptoms (EPS) were evaluated by a questionnaire based on the UKU scale, and sexual dysfunction by the Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ).


RESULTS
The mean (+/- SD) modal dose throughout the study was 12.3 (+/- 6.3) mg/day for olanzapine and 5.2 (+/- 2.5) mg/day for risperidone. EPS were significantly more frequent in the risperidone-treated patients 50.4 % versus 28.9 % for olanzapine (p = 0.0006). Olanzapine patients showed significantly greater reductions (improvement) from baseline in the PRSexDQ score (p=0.0292) and risperidone patients reported significantly more sexual adverse events (21.1% versus 7.3% for olanzapine; p=0.0018). Mean body weight gain was not significantly different at endpoint (3.5 kg gained with olanzapine versus 1.9 kg gained with risperidone; p=0.3522), but the proportion of patients showing a body weight increase > or =7% was higher among the olanzapine-treated patients (37.8% versus 16.8%; p=0.0012).


CONCLUSIONS
Significantly less treatment-emergent extrapyramidal and sexual adverse events were observed in patients treated with olanzapine compared to those treated with risperidone. Mean body weight increases with both drugs were not significantly different after one year. Olanzapine patients presented a significantly higher incidence of clinically important body weight increase when compared with patients treated with risperidone.
Ciudad
A
A
Departamento de Investigación Clínica, Eli Lilly & Co., Lilly Research Laboratories, Av. de la Industria 30, 28108 Alcobendas, Madrid. ciudad_antonio@Lilly.com
Alvarez
E
E
Bousoño
M
M
Olivares
J M
JM
Gómez
J C
JC
D000328:Adult; D000339:Affect; D014150:Antipsychotic Agents / Q000009:adverse effects*; D001569:Benzodiazepines / Q000009:adverse effects; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D000077152:Olanzapine; D018967:Risperidone / Q000009:adverse effects*; D012559:Schizophrenia / Q000188:drug therapy*
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D018967:Risperidone; D000077152:Olanzapine