|New Research Shows Significant Benefits of Medtronic Deep Brain Stimulation Earlier in Progression of Parkinson's Disease|
EARLYSTIM study results published in The New England Journal of Medicine show remarkable improvements in patient quality of life and motor disability
TOLOCHENAZ, SWITZERLAND – Feb. 14, 2013 – 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 therapy only.1
Additional key EARLYSTIM study findings at two years include:
“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
The therapy is currently approved in many locations around the world, including 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). In Europe and Canada, 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
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.
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 2013;19:56-61
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
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