ORIGINAL PAPERS PRACE ORYGINALNE
Safety and tolerance of generic olanzapine formulation (Zapilux®) in therapy of patients with schizophrenia – results of a post-marketing, non-randomized, non-interventional, multicenter survey in outpatient treatment Bezpieczeństwo i tolerancja preparatu generycznego olanzapiny (Zapilux®) w leczeniu chorych na schizofrenię – wyniki porejestracyjnego, nierandomizowanego, nieinterwencyjnego, wieloośrodkowego badania prowadzonego w praktyce ambulatoryjnej Magdalena Olszanecka-Glinianowicz
Key words:
schizophrenia, olanzapine, safety, tolerability
Słowa kluczowe: schizofrenia, olanzapina, bezpieczeństwo, tolerancja
Health Promotion and Obesity Management Unit, Department od Pathophysiology Medical University of Silesia in Katowice Zakład Promocji Zdrowia i Leczenia Otyłości, Katedra Patofizjologii Śląskiego Uniwersytetu Medycznego w Katowicach Professor Magdalena OlszaneckaGlinianowicz, MD, PhD Head of the Unit CORRESPONDENCE ADDRESS: Dr hab. n. med. Magdalena Olszanecka-Glinianowicz, Prof. nadzw. SUM Zakład Promocji Zdrowia i Leczenia Otyłości Katedra Patofizjologii Śląskiego Uniwersytetu Medycznego w Katowicach ul. Medyków 18 40-752 Katowice
[email protected]
RECEIVED: 26.09.2012 ACCEPTED: 28.09.2012
Abstract:
Background. Olanzapine affecting the activity of serotonin and dopamine neurons exerts an antipsychotic, antimanic and mood stabilizing actions. Aim. The aim of the study was to evaluate the safety and tolerance of generic olanzapine formulation – Zapilux® in the Polish population of patients with schizophrenia in outpatient treatment. Patients and methods. The post-marketing, non-randomized, non-interventional, multicenter survey involved 1,631 patients with schizophrenia treated with olanzapine generic formulation – Zapilux®, at least 14 days prior to enrollment. The observation period was 30±8 weeks. During the three planned visits the adverse events (AE) associated with drug administration were recorded and the subjective tolerance was evaluated based on five-point scale. Clinical status of patients was assessed by CGI-S, and the attitude toward the drug using DAI-10. Results. The AEs were the reason for discontinuation of therapy only in one patient (0.06%). Adverse events possibly related to the drug have been reported in 100 patients (6.2% of the study group). There was no serious AE. The most commonly reported AEs were weight gain (3.1%), and somnolence (2.0%). Weight gain on visit 1 was observed in 78.3% study subjects and on visit 2 further body mass increase was shown in 32.9%. The percentage of patients assessing the drug tolerance as very good significantly increased with period of observation (30.3% vs. 47.1%, p
