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

ABSTRACT

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