TOLOCHENAZ, SWITZERLAND and BRAMPTON, ONTARIO--(Marketwire - Feb. 14, 2013) -
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Results from a clinical study published today in The New England Journal of Medicine show that use of Medtronic (NYSE:MDT) deep brain stimulation (DBS) therapy provides superior benefits for patients with early motor complications from Parkinson's disease when compared with best medical treatment only.1
The first large, multicentre, randomized, controlled trial to evaluate Parkinson's patients with early motor complications2 showed patients treated with DBS therapy and best medical treatment reported a mean improvement of 26 per cent in their disease-related quality of life at two years (p=0.002), compared with no improvements in patients treated with best medical therapy alone.3 The clinical trial included 251 people with Parkinson's disease at 17 centres in Germany and France and followed them over the course of two years.
Additional key EARLYSTIM study findings at two years include:
- A 53 per cent improvement in motor skills (in an off-medication condition) in patients treated with Medtronic DBS therapy, compared to no change in those receiving best medical therapy only (p<0.001).4
- A 30 per cent improvement in various activities of daily life, including speech, handwriting, dressing and walking, in participants with Medtronic DBS therapy while in the worst condition ("off time"), compared to a 12 per cent decline in those receiving best medical therapy only (p<0.001).5
- A 61 per cent improvement in levodopa-induced complications, including dyskinesias and motor fluctuations, in participants receiving Medtronic DBS therapy at two years, compared to a 13 per cent worsening in those only receiving best medical therapy (p <0.001).6
- A 39 per cent reduction in daily levodopa equivalent dosage in the Medtronic DBS therapy group, versus a 21 per cent increase in dosage in participants receiving best medical therapy alone (p <0.001).
"These results signal a shift in the way patients with Parkinson's disease can be treated, and prove that deep brain stimulation therapy can improve patients' quality of life even in the earlier stages of Parkinson's disease, when fluctuations and dyskinesia just start and clinicians traditionally rely solely on drugs," said Günther Deuschl, Professor of Neurology at Christian-Albrechts-University in Kiel, and lead investigator of the EARLYSTIM study for Germany.
"These results can allow clinicians to feel confident using DBS therapy earlier in the progression of the disease for patients meeting the appropriate selection criteria," said Yves Agid, Professor of Neurology, Pitié-Salpêtrière University Hospital in Paris, and lead investigator of the EARLYSTIM study for France.
Currently, DBS therapy is primarily used to treat Parkinson's patients in the advanced stages of Parkinson's disease with disabling levodopa-induced motor complications which can no longer be treated successfully with medication alone. EARLYSTIM trial participants on average had been experiencing symptoms of Parkinson's disease with a mean disease duration of 7.5 years, roughly five years less than participants in earlier trials2, allowing researchers to test the benefits of DBS therapy when motor fluctuations and dyskinesia are of recent onset and occupational and psychosocial competence is still maintained. The enrolled patient population was also at an earlier stage of the disease as evaluated by disability staging criteria of the Hoehn & Yahr scale2, which is a commonly used system for describing how the symptoms of Parkinson's disease progress.
"This is an exciting new development in the management of Parkinson's disease. This study shows that it is not only safe to treat Parkinson's patients at an earlier stage with deep brain stimulation, but also that patients receive therapeutic benefits over best medical management. In other words, this expands the range of the therapeutic window during which patients can benefit from DBS," said Lothar Krinke, Ph.D., vice president and general manager of the global deep brain stimulation business in Medtronic's Neuromodulation division. "Medtronic is committed to supporting research like EARLYSTIM, which represents a unique collaboration between industry and academia."
The clinical trial's primary safety parameters, such as psychological well-being and memory, and the overall incidence of adverse events did not differ significantly between the two treatment groups. Compared to best medical therapy, there were more patients in the neurostimulation (DBS) group with serious adverse events. This safety profile is similar in type and frequency to current Medtronic DBS therapy for Parkinson's disease.
ABOUT MEDTRONIC DBS THERAPY
DBS therapy uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. Electrical stimulation of these areas results in improvement of parkinsonian motor signs and of levodopa-induced motor complications. The stimulation can be programmed and adjusted non-invasively by a trained clinician to maximize symptom control and minimize side effects. More than 100,000 patients worldwide have received Medtronic DBS Therapy.
The therapy is currently approved in many locations around the world, including Canada, Europe and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE). DBS therapy for early stage Parkinson's disease is not available for sale in the United States. In Canada and Europe, DBS therapy is approved for the treatment of refractory epilepsy. The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and in the United States under an HDE.
MEDTRONIC'S LEADERSHIP IN NEUROMODULATION
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company's Neuromodulation business includes neurostimulation and implantable, targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.
Medtronic of Canada Ltd. is a trusted Canadian leader delivering innovative health system solutions and advanced medical technologies to alleviate pain, restore health, and extend life in the areas of cardiovascular medicine, diabetes, spinal and neurosurgery, and ear, nose, throat surgery. Medtronic is proud to employ more than 745 Canadians. Headquartered in Brampton, Ontario, Medtronic has regional offices in Vancouver and Montreal, including a manufacturing facility, Medtronic CryoCath, located in Pointe-Claire, Quebec.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. This release is not intended for distribution in the United States or to United States newswire services.
1 Schuepbach WMM, Rau J, Knudsen K, et al., Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med 2013;368:610-22
2 Deuschl G, et al., Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: Concept and standards of the EARLYSTIM-study, Parkinsonism and Related Disorders (2012), http://dx.doi.org/10.1016/j.parkreldis.2012.07.004
3 Quality of life assessed with the Parkinson's Disease Questionnaire (PDQ-39)-Summary-Index.
4 assessed with the Unified Parkinson's Disease Rating Scale part III
5 assessed with the Unified Parkinson's Disease Rating Scale part II
6 assessed with the Unified Parkinson's Disease Rating Scale part IV