A 6-month prospective study on efficacy safety and QOL profiles of extended-release formulation of valproate in patients with epilepsy

Abstract

The goals of this study were to evaluate the efficacy, safety, and quality of life profiles of ER formulation of valproate in patients with epilepsy. This was a prospective, multicentre, open-lable study. Patients with a definite diagnosis of epilepsy were included and prescribed the ER formulation of valproate as initial or add-on therapy for 6 months. Efficacy and safety re-evaluation procedures were performed at 1 (V1), 3 (V2), and 6 months (V3) after enrolment. A QOLIE-31 inventory was used to assess the quality of life before and after the 6-month treatment. Nine hundred and fifty-eight patients with diagnosis of epilepsy were included in the analysis. The mean of seizure frequency at baseline was 8.56 per month. The median maintenance dose of the ER valproate was 750 mg per day. The number of seizure attacks per month was significantly decreased at the last visit compared to baseline by 88.3%. Patients improved quality of life in the fields of ‘seizure worry’ (P = 0.000), ‘overall quality of life’ (P = 0.000), ‘social function’ (P < 0.01), and ‘Question 31′ (P = 0.000), but showed decreased ‘energy’ (P = 0.000). In the early phase of treatment, the main adverse effects included drowsiness, dizziness, and anorexia. By 6 months of treatment, weight gain, alopecia, and tremor were most frequently reported. The results of the present study demonstrated that patients receiving ER valproate as add-on or mono-therapy for 6 months exhibited significantly greater median percent reductions from baseline in seizure frequency for all seizure types, and significantly higher responder rates and higher seizure freedom rates, with good tolerance and improved quality of life.