Aim of the study: to evaluate effectiveness and safety of generic olanzapine (Zolafren®) under the conditions of routine clinical practice in Poland.
Material and methods: an open-label, prospective, multicentre and non-interventional study. Primary effectiveness parameter was a change in PANSS scale, while primary safety and tolerance parameters were drop-outs due to side effects, a change in Simpson-Angus scale and weight gain. From the initially completed 6019 case reports forms, data on 5144 subjects with schizophrenia aged 18–65 were included in the final analysis.
Results: drop-out rate due to side effects was 1.2%, considerably lower than in randomized controlled trials. Marginal, though statistically significant reduction in Simpson-Angus scale was observed, the finding that might be interpreted as no influence on extrapyramidal symptoms. Mean weight gain was 2 kg, being higher in patients younger than 30 (particularly women) and lower in those older than 55. Mean reduction in total PANSS scale was 30 points after 6–8 weeks, supporting strongly clinical effectiveness of the drug.
Conclusions: generic olanzapine (Zolafren®) proved to be safe and effective in patients treated routinely as evaluated by prospective, open-label study. Age and, to lesser extend, gender, might be important factors modifying safety and tolerance, particularly weight gain and possible metabolic complications.