Objective To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS+BMP) is superior to BMPalone in improving long-term health-related quality of life (HRQoL). Methods PuLsE (Open Prospective Randomized Long-term Effectiveness) was a prospective, randomized, parallel-group, open-label, and long-term effectiveness study (conducted at 28sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n=112) received VNS+BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary endpoints included changes in seizure frequency, responder rate (50% decrease in seizure frequency), Centre for Epidemiologic Studies Depression scale (CES-D), Neurological Disorders Depression Inventory-Epilepsy scale (NDDI-E), Clinical Global Impression-Improvement scale (CGI-I), Adverse Event Profile(AEP), and antiepileptic drug(AED) load. The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n=362. Results for n=96 who had baseline and at least one follow-up QOLIE-89 assessment (from months3-12) were included in this analysis. Mixed model repeated measures (MMRM) analysis of variance was performed on change from baseline for the primary and secondary endpoints. Results Significant between-group differences in favor of VNS+BMP were observed regarding improvement in HRQoL, seizure frequency, and CGI-I score (respective p-values<0.05, 0.03, and 0.01). More patients in the VNS+BMP group (43%) reported adverse events(AEs) versus BMP group (21%) (p=0.01), a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation. No significant difference between treatment groups was observed for changes in CES-D, NDDI-E, AEP, and AED load. Significance VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone.

The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: The PuLsE (OpenProspective RandomizedLong-termEffectiveness) trial

BENNA, Paolo;
2014-01-01

Abstract

Objective To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS+BMP) is superior to BMPalone in improving long-term health-related quality of life (HRQoL). Methods PuLsE (Open Prospective Randomized Long-term Effectiveness) was a prospective, randomized, parallel-group, open-label, and long-term effectiveness study (conducted at 28sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n=112) received VNS+BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary endpoints included changes in seizure frequency, responder rate (50% decrease in seizure frequency), Centre for Epidemiologic Studies Depression scale (CES-D), Neurological Disorders Depression Inventory-Epilepsy scale (NDDI-E), Clinical Global Impression-Improvement scale (CGI-I), Adverse Event Profile(AEP), and antiepileptic drug(AED) load. The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n=362. Results for n=96 who had baseline and at least one follow-up QOLIE-89 assessment (from months3-12) were included in this analysis. Mixed model repeated measures (MMRM) analysis of variance was performed on change from baseline for the primary and secondary endpoints. Results Significant between-group differences in favor of VNS+BMP were observed regarding improvement in HRQoL, seizure frequency, and CGI-I score (respective p-values<0.05, 0.03, and 0.01). More patients in the VNS+BMP group (43%) reported adverse events(AEs) versus BMP group (21%) (p=0.01), a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation. No significant difference between treatment groups was observed for changes in CES-D, NDDI-E, AEP, and AED load. Significance VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone.
2014
55
6
893
900
Epilepsy, Health-related quality of life, QOLIE-89, Seizures, Vagus nerve stimulation
Philippe Ryvlin;Frank G. Gilliam;Dang K. Nguyen;Gabriella Colicchio;Alfonso Iudice;Paolo Tinuper;Nelia Zamponi;Umberto Aguglia;Louis Wagner;Lorella Minotti;Hermann Stefan;Paul Boon;Mark Sadler;Paolo Benna;Pradheep Raman;Emilio Perucca
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/155612
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