Posted by djmmm on February 4, 2002, at 17:16:50
In reply to Re: New medications » djmmm, posted by bob on February 4, 2002, at 16:04:49
> Don't mean to be a wet blanket here, but I have a correction to your info; Cyberonics will not be getting FDA approval for their device this year. They announced disappointing results from their pivotal study where the response was not "statistically different" from placebo. They claim it was entirely due to a flawed study, and not to the device being ineffective. That are planning another pivotal study to prove their point. If this next study is a success, the approval would probably be sometime in 2004 - 2005.
are you sure? this is from Dec of *2001*
Medical University Of South Carolina Release: Vagus Nerve Stimulation Therapy Continues To Show Long-Term Benefits For Chronic Or Recurrent Depression
CHARLESTON, S.C., Dec. 18 /PRNewswire/ -- New long-term findings demonstrate that patients with difficult to treat chronic or recurrent depression continue to respond to vagus nerve stimulation (VNS) therapy for up to two years. Results from the 60-patient long-term study, led by Mark George, MD, distinguished professor, departments of Psychiatry, Radiology and Neurology at the Medical University of South Carolina, indicate that extended treatment with VNS is associated with the elimination or reduction of depressive symptoms and an improved ability to perform daily functions.
The study, conducted to determine whether the promising results seen in an acute phase (three month) pilot study were sustained after one to two years of treatment with VNS, used remission and response rates as the primary indicators of success. Response means that a patient's depression symptoms were cut in half; remission means that a patient has become virtually symptom-free. The study found that depressed patients with VNS improved over time in terms of remission and response and also improved in their ability to function:
* 27% of patients were in remission after one year, increasing from 15% at the end of the acute study;
* 45% of patients responded to treatment after one year, increasing from 31% at the end of the acute study; and
``There is a need for a more effective and tolerable long-term treatment because 20 to 30 percent of Americans with depression do not respond satisfactorily to currently available treatments,'' stated George. ``The results from this long-term study suggest that VNS could be an effective long-term therapy to help people with chronic and recurrent depression maintain a better quality of life and higher level of day-to-day functioning.''
Depression is a mental illness of global proportions, affecting approximately 340 million people worldwide and more than 18 million American adults. Furthermore, major depression is a leading cause of disability. The illness is characterized by sad moods, loss of interest or pleasure, feelings of guilt or low self-esteem, disturbed sleep and appetite, low energy level and the decreased ability to concentrate. These problems many times become chronic or recurrent and prevent those affected from performing everyday tasks and family and occupational responsibilities.
``Depression is a chronic, disabling lifelong illness that requires a well-tolerated treatment that provides both acute symptom relief and continued benefits,'' stated Harold Sackeim, Ph.D., professor, department of Psychiatry and Radiology, Columbia College of Physicians and Surgeons and New York State Psychiatric Institute. ``Studies of VNS for depression thus far indicate that this therapy may be an option for patients who have not had a positive long-term response to commonly available treatments.''
also, it was approved in canada in April of 2001, and approved in the EU in March of 2001.
poster:djmmm
thread:92834
URL: http://www.dr-bob.org/babble/20020131/msgs/92862.html