VNS Therapy: safe and tolerable
The safety and tolerability of VNS Therapy are numerous and significant. Sleep disturbance and weight gain (commonly reported with other antidepressant treatments) have been reported by less than 2% of patients receiving VNS 1. VNS Therapy has not been associated with sexual dysfunction 1. VNS Therapy has shown no evidence of deterioration in any neurocognitive measures 2. There are no undesired drug interactions with VNS Therapy and concurrent antidepressant medication.1 VNS Therapy has no systemic neurotoxic effects.1 Unlike ECT, VNS Therapy has shown no evidence of deterioration in any neurocognitive measures.2 In addition, animal studies have revealed no evidence of impaired fertility or harm to the fetus due to VNS Therapy.1
90% of patients in the Pivotal Study showed either improvement (56%) or no change (34%) in their scores on the item-3 of the HAMD24. Finally, the safety of VNS Therapy is well established—over 30,000 patients have received VNS Therapy as an adjunctive treatment for pharmacoresistant epilepsy since 1997.3
VNS Therapy: side effects that typically decrease over time
Mild to moderate side effects occur only during stimulation and may be minimized through dose adjustments.4,5 Side effects also typically decrease over time.4 On-demand magnet use allows acute control of side effects by temporarily discontinuing stimulation.1
The most common side effects with VNS Therapy include temporary hoarseness or a slight change in voice tone, increased coughing, shortness of breath upon physical exertion, and a tickling in the throat.4
*The sensation of shortness of breath was reported only during physical exertion.
Efficacy, safety, and tolerability contribute to high continuation rates
The discontinuation rate due to side effects was 3% at 1 year during the Pivotal Study4
*Discontinuations with or without explant.
Hear from a physician
"One of the very nice things about VNS Therapy is that we — the doctor, the patient — know what the side effects will be when the patient leaves the office, unlike medication where you might raise the dose and not know what the side effects are ultimately for a week or two. We can control the side effects by engaging, collaborating with the patient as to the proper amount of current, a well-tolerated amount of current, that is still sufficient to give a therapeutic effect."
—Dr. A. John Rush, Vice Chair, Department of Clinical Sciences Professor, Department of Psychiatry University of Texas Southwestern Medical Center at Dallas
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Hear from a patient
"When I first began the VNS Therapy I had some side effects, including a raspy voice, especially when we would increase the dose of the therapy...We continued to adjust the dose until I virtually have no side effects in my voice now."
— Marna, VNS Therapy since 2000
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1. Physician's Manual. VNS TherapyTM Pulse Model 102 Generator and VNS TherapyTM Pulse Duo Model Generator. Houston, Tex: Cyberonics, Inc; 2006.
2. Sackeim HA, Keilp JG, Rush AJ, et al. The effects of vagus nerve stimulation on cognitive performance in patients with treatment-resistant depression. Neuropsychiatry Neuropsychol Behav Neurol. 2001;14:53-62.
3. Data on file. Cyberonics, Inc.
4.Rush AJ, Sackeim HA, Marangell LB, et al. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry. 2005;58:355-363.
5.Rush AJ, Marangell LB, Sackeim HA, et al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry. 2005;58:347-354.