Short-term efficacy and safety of valproate sustained-release formulation in newly diagnosed partial epilepsy VIPe-study. A multicenter observational open-label study

OBJECTIVE: To evaluate the efficacy and safety of valproate (VPA) sustained-released in monotherapy across all ages in newly-diagnosed epileptic patients with partial seizures (PS) with or without secondary generalization.

METHODS: This was a multicenter, prospective, observational, open-label, non-comparative study involving the Gulf Cooperation Council (GCC) countries except the Kingdom of Saudi Arabia, and was performed between November 2004 and May 2006. Adults and children (6 years or older with newly diagnosed partial epilepsy [PE]) with or without secondary generalization were enrolled. The primary efficacy parameter was 6 month-remission rate (proportion of seizure-free patients in relation to total number of retained patients). Secondary efficacy parameters included: 6 month-retention rate, investigator's clinical global impression rating, maximal effective dose and safety profile.

RESULTS: Seventy-seven patients were enrolled; 56% adults and 44% children, with average duration of epilepsy of 5 months in the pediatric and 17 months in the adult group. Seizures type distribution: PS with secondary generalization (62%), complex PS (53%) and simple PS (14%). The majority had idiopathic seizures (48%). Sixty-six patients completed the study (treatment retention rate 80.5%). At 6 months, 87% of patients became seizure free with VPA sustained-release monotherapy (average dose 22 mg/kg/day). Adverse drug reactions (hair loss and tremor) were recorded in <20% of patients, mostly affecting adults.

CONCLUSION: In this population, short-term treatment with VPA sustained-release in monotherapy provides good seizure control and is well tolerated.