Authors :
Presenting Author: Ryan Verner, PhD – LivaNova PLC (or a subsidiary)
Firas Fahoum, MD – Faculty of Medical & Health Sciences, Tel Aviv University; Neurological Institute, Tel Aviv Sourasky Medical Center
Riëm El Tahry, MD, PhD – Institute of Neurosciences, UCLouvain, Brussels, Belgium
James Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES, FCNS – University of Tennessee Health Science Center and Le Bonheur Children's Hospital
Jeremy Freeman, MD – The Royal Melbourne Hospital
George Morris, MD, MPH, DIC – Ascension Wisconsin, St. Mary's Hospital, Milwaukee, WI, USA
Gaia Giannicola, PhD – LivaNova PLC (or a subsidiary)
Paul Lyons, MD PhD – Winchester Neurological Consultants
Youssef Al Said, MD – King Faisal Specialist Hospital & Research Centre
Xiangping Zhou, MD, PhD – SUNY Upstate
Michal Tzadok, MD – Tel Aviv University
Gholam Motamedi, MD – Georgetown University Medical Center
Arjune Sen, MD PhD – University of Oxford
Patrick Kwan, BMedSci, BM, BChir, FRACP, PhD, FAHMS – Monash Institute of Medical Engineering, Monash Univeristy
Maxine Dibue, PhD – LivaNova PLC
Lorenzo Acciari, BS – Valos Srl
Charles Gordon, PhD – LivaNova PLC (or a subsidiary)
Kathryn Nichol, PhD – LivaNova PLC (or a subsidiary)
Rhys Thomas, MD PhD – Newcastle University
Rationale:
The utilization of rescue medications remains an important consideration in the management of drug-resistant epilepsy (DRE), regardless of prescribed anti-seizure therapy. While VNS Therapy has been shown to reduce seizure frequency over time, understanding its impact specifically on the need for rescue medications offers additional insight into clinical outcomes and patient/care provider quality of life.
Methods:
People with DRE enrolled in the CORE-VNS (NCT03529045) study were assessed for rescue medication use at baseline and study visits at 3, 6, 12, 24, and 36 months. Rescue medication use rate was calculated as the number of times a rescue medication was used divided by the duration of the period of interest in months (e.g., 1 use in 12 months was 0.083). Participants who reported at least one rescue medication usage during the 12 months preceding baseline were included in this analysis.
Results:
Of the people with DRE who met the CORE-VNS study criteria and received their first VNS Therapy implant, 158 reported rescue medication use during the 12 months preceding baseline. The median use rate was 0.71 (95% CI: 0.42; 1.00) with baseline mean of 3.25 rescue medication usage per month.
Use of rescue medications decreased at each visit following VNS Therapy implantation. At the 3-month visit, a median change of -0.25 (95% CI:-0.33; -0.17, p< 0.0001) was noted, with a reported mean rescue medication use of 1.53. At 36 months, the median change in use rate from baseline was -0.45 (95% CI: -0.67; -0.26, p< 0.0001) with a reported mean rescue medication use of 0.86 per month.