Safety and tolerance of generic levetiracetam formulation (Vetira®) in therapy of Polish patients diagnosed with epilepsy – results of a postmarketing, non-randomized, non-interventional, multicenter survey in outpatient practice Original article
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Abstract
Introduction: The Vetira® generic formulation of levetiracetam has been registered on the basis of pharmacokinetic studies that confirmed the compliance of its activity profile with the original formulation. However, before the registration of the clinical trials evaluating the safety and tolerability profile of the generic formulation have not been performed within the Polish population of patients diagnosed with epilepsy. The aim of this study was to evaluate the safety and tolerability of different doses and formulations of the Vetira® in the population of Polish patients diagnosed with epilepsy.
Patients and Methods: Adverse reactions associated with the use of levetiracetam were recorded and reported in the post-marketing, open, non-randomized, multicenter, observational study conducted among 1828 patients diagnosed with epilepsy, in which the generic formulation was used for at least 14 days prior to study enrollment.
Results: During mean of 122 ± 32 days of observation 183 adverse events possible related to the use of Vetira® were reported in 56 patients (3.06% of the study group). All adverse events were previously described for the original preparation. Three adverse events that occurred in one patient and severe one reported in another patient were resulted in dropouts. On the last visit of the study, 97.3% of patients esteemed the tolerability of Vetira® as good or very good, and any patient reported its poor tolerance (the presence of adverse events, non-acceptable discont fort). The most commonly reported adverse events were somnolence and fatigue (1.37% and 1.20% of the study population, respectively). 120-day adherence to Vetira® formulation was estimated at 79.7%.
Conclusion: The Vetira® generic formulation levetiracetam is safe and well tolerated by patients diagnosed with epilepsy in outpatient clinics.
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