Abstract
Introduction:
Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated for up to nearly 3 years, are presented for asenapine and olanzapine.
Methods:
Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.
Results:
290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time [mean±SD (range) 311.0±146.1 (10 − 653) d and 327.4±139.6 (15 − 631) d, respectively]. Adverse event (AE) incidence was lower during the extension (asenapine, 62%; olanzapine, 55%) than during the core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were − 37.0 for asenapine and − 35.3 for olanzapine, with further changes of 1.6 for asenapine and − 0.8 for olanzapine at the extension study endpoint.
Conclusions:
Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.
NCT number: NCT00212771
Key words
asenapine - schizoaffective disorder - schizophrenia - tolerability - olanzapine
