A unique feature of VNS Therapy is its ability
to improve seizure control over time. The long-term impact of VNS
Therapy was assessed in an open-label, long-term study of 454 epilepsy
patients using data from all 5 VNS Therapy controlled, clinical
trials. The study compared the percentage of patients with seizure
reductions of >= 50% over a 3-year period. The percentage of
patients with >= 50% seizure reduction was 36.8 at 1 year, 43.2
at 2 years, and 42.7 at 3 years. Tolerance to the therapeutic effects
of treatment does not appear to occur with VNS Therapy. 1
The VNS Therapy Patient Outcome Registry also provides evidence
of the long-term efficacy of this therapy. The VNS Therapy Patient
Outcome Registry is a voluntary patient outcome registry for patients
implanted with the VNS Therapy. The Registry is the first long-term
patient outcome registry in epilepsy, and it includes quality-of-life
and seizure control data. Physicians have access to long-term patient
outcomes and can query the database for information based on particular
patient characteristics, which can be helpful when considering a
new patient for VNS Therapy.
Registry data were collected at implantation and
at 3, 6, 12, 18, and 24 months. To assess long-term seizure control,
3-, 12-, and 24-month data from cohorts of VNS Therapy Patient Outcome
Registry patients were analyzed as of April 2003. The cohorts analyzed
included 2229 patients with 3- and 12-month data and 775 patients
with 24-month data. Notably, more than half of Registry patients
had >= 50% seizure reductioin at 12 months, and as many as 59%
had >= 50% reductions at 24 months.
1Morris GL III, Mueller
WM. Neurology. 1999;53:1731-1735.
2Data on file, April 2003, Cyberonics, Inc
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