“Many patients have had epilepsy for well over five years before being treated with VNS Therapy, even if medications have been unsuccessful in controlling their seizures” says study investigator James Wheless, M.D., director of the Texas Comprehensive Epilepsy Program at University of Texas Medical School at Houston. “This study demonstrates that people with epilepsy shouldn’t wait through years of failed drug therapies and associated side effects before trying VNS Therapy—the therapy works better when used earlier in the treatment course.”
This study prospectively followed a group of VNS Therapy patients who had been diagnosed with epilepsy less than five years before implantation or who had tried four or fewer AEDs (n=120) to determine if using VNS Therapy earlier in the treatment course improves efficacy. The control group was identified retrospectively from the VNS patient outcome registry and was composed of VNS Therapy patients who were implanted more than five years after diagnosis. Preliminary results showed that after three months of treatment with VNS Therapy, fifteen percent of the study participants reported no seizures, a three-fold statistically significant improvement over the control group.
Additionally, and equally as important, patients’ quality of life after three months of VNS Therapy was “better” or “much better” based on several quality of life indicators, including seizure recovery period (postictal state), alertness, mood, verbal communications, memory, and achievement at work or school.
“Side effects from AEDs, including weight gain or loss, fatigue, drowsiness and memory problems, often have a serious impact on a patient’s quality of life, especially if the patient is taking more than one medication,” said James B. Renfroe, M.D., pediatric neurologist at the Child Neurology Center of Northwest Florida. “VNS Therapy is one treatment option that frees a patient from these life-altering side effects, while at the same time controlling their seizures.”
About Epilepsy
Epilepsy is the third most common neurological disorder in the United States and affects nearly 2.3 million people, or one percent of the U.S. population. According to recent estimates, 422,000 U.S. children aged 18 years and younger have been diagnosed with epilepsy, while about 181,000 otherwise healthy Americans of all ages develop epilepsy each year.
Epilepsy is a chronic neurological disorder characterized by two or more, unprovoked recurrent seizures. These “electrical storms” in the brain, which are caused by faster-than-normal activity among the brain’s nerve cells, affect many of the body’s functions and can cause more than 30 different types of seizures. The severity of seizures ranges from finger twitching to unrecognizable speech to convulsions and unconsciousness.
Available treatments, either drugs or surgery, control seizures in 70 to 80 percent of cases, but for the more than 600,000 American who have refractory epilepsy, seizure control remains elusive and continues to have a significant impact on their personal and professional lives.
About VNS Therapy
VNS Therapy is an innovative long-term therapy for central nervous system disorders, which has been demonstrated to be safe and effective for people with epilepsy. VNS Therapy is delivered via a small pacemaker-like device, implanted just under the skin in the left chest pocket, which sends mild electrical stimulation to the brain via the left vagus nerve.
VNS Therapy has been proven to decrease or sometimes eliminate seizures and may improve quality of life in many patients whose seizures do not respond to medications alone. In addition,
VNS Therapy has not been reported to cause any of the devastating side effects that are commonly associated with AEDs, and may allow some people with epilepsy to reduce the number or dose of the antiepileptic medications they take.
VNS Therapy with the Cyberonics NCP® System was approved in 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with medically refractory partial onset seizures. In addition, the NCP System is currently approved for epilepsy in all the member countries of the European Union, Canada, and Australia. VNS with the Cyberonics NCP System is also approved for sale in the European Union and in Canada as a depression treatment in patients with treatment-resistant or treatment-intolerant major depressive episodes including unipolar depression and bipolar disorder (manic depression).
Cyberonics, Inc. (Nasdaq: CYBX) was founded in 1987 to help improve the lives of people touched by epilepsy, depression and other chronic disorders that may prove to be treatable with VNS. Cyberonics is headquartered in Houston, Texas, USA, with an office in Belgium. For additional information, please visit www.cyberonics.com.
Contacts:
Porter Novelli
Meaghan Atkinson
(212) 601-8438
Nicole Christopher
(212) 601-8279