Cyberonics has announced positive results from the Pulse (Open prospective randomised long-term effectiveness) study vagus nerve stimulation (VNS) therapy in patients with refractory epilepsy conducted at 28 sites in Europe and Canada and published in the peer-reviewed journal Epilepsia.
The goal of this comparative effectiveness study, designed to reflect clinical practice, was to evaluate whether vagus nerve stimulation therapy plus best medical practice (defined as individualised therapy judged optimal by investigators at each visit for each patient) is superior to best medical practice alone in improving health-related quality of life (HRQoL). One hundred and twelve adults with drug-resistant focal seizures were randomised to adjunctive vagus nerve stimulation therapy plus best medical practice or best medical practice alone. The primary endpoint was mean change from baseline in the 89-item Quality of Life in Epilepsy Inventory (QOLIE-89) total score. The QOLIE-89 assessment tool is the most comprehensive epilepsy-specific measure of health-related quality of life currently available.
Significant between-group differences in favour of vagus nerve stimulation therapy plus best medical practice were observed regarding improvement in HRQoL, seizure frequency, and CGI-I (Clinical Global Impression – Improvement) score (p values <0.05, 0.03, and 0.01, respectively). The results from this trial provide further evidence for the added value of adjunctive vagus nerve stimulation therapy in patients with drug-resistant focal epilepsy who are not candidates for surgical resection. Moreover, the findings demonstrate that the benefits of adding vagus nerve stimulation therapy extend beyond the reduction in seizure frequency. The safety profile of vagus nerve stimulation therapy was comparable to other studies reported in product labelling and in the literature.
“The Pulse study is important because it is one of the few clinical trials in epilepsy that used Quality of Life as the primary endpoint, supplemented by additional health- and epilepsy-related measures,” states Frank Gilliam, professor of Neurology, Pennsylvania State University, Hershey Medical Center, USA. “The results demonstrated that vagus nerve stimulation therapy improved Quality of Life and seizure rates compared to best medical management in patients with pharmacoresistant epilepsy. Further studies will help us better understand the determinants of improved quality of life following treatment with vagus nerve stimulation therapy.”