- Spasticity Affects a Significant Number of Post-Stroke Patients,[1],[2],[3] and Many are not Adequately Treated by Standard Therapy [4]
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Medtronic, Inc. (NYSE: MDT) today announced the enrollment of the firstEuropean patients in the largest randomized controlled trial to date toinvestigate the benefits of ITB Therapy(R) (Intrathecal Baclofen) inpost-stroke patients affected by spasticity. The announcement comes as theWorld Congress for Neurorehabilitation is taking place in Vienna, Austria.
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The SISTERS study (Spasticity In STrokE Randomised Study) is expected toprovide high-quality evidence on the efficacy of ITB Therapy, enablinghealthcare professionals to make treatment decisions for post-stroke patientswith severe spasticity who do not respond sufficiently to oral medication andphysical therapy.
Stroke is a major cause of disability, with 15 million new cases eachyear worldwide,[5] and over one million people suffering a stroke in WesternEurope every year.[6] Of these patients, up to 65 percent will suffer fromspasticity as a result,[3] and for many of them, oral medication and/orphysical therapy combined are not enough to manage spasticity.4 Post-strokespasticity patients have reduced function and lower quality of life thanpatients without the disability.[7,8]
ITB Therapy is an approved treatment for patients with severe generalizedspasticity associated with multiple sclerosis, cerebral palsy, spinal cordinjury, brain injury, and stroke who do not respond to oral medication. ITBTherapy treats severe non-focal spasticity through a programmable pump, whichis placed under the skin of the abdomen and connected to a catheter.
Once in place, the pump and catheter deliver anti-spastic medicationdirectly to the site of action in the cerebrospinal fluid surrounding thespinal cord, where it may be is most effective.[9] Due to its directadministration into the spine, ITB Therapy requires a lower dosage ofmedication compared to oral treatments, while producing a similar reductionin spasticity with fewer possible side effects than what is often seen withhigher doses of oral baclofen.[9]
"ITB Therapy has the potential to restore quality of life in patientswhose lives have been completely disrupted by a stroke and the impairing anddebilitating symptoms of spasticity," commented Professor Leopold Saltuari(LKH Hochzirl, Austria), global lead investigator of the SISTERS study. "Withthis study we are aiming to demonstrate that there is a way to managespasticity for many of them."
The SISTERS study is an international trial, conducted in 20 sites inEurope and the US, including European centres in Austria, Belgium, Germany,Italy, the Netherlands, Spain, and the United Kingdom. The primary endpointis the reduction of spasticity after six months of treatment with ITB Therapyand physical therapy compared to patients treated with one or more oralmedications and physical therapy. Assessments include a 10-meter timedwalking test, other functionality and independence tests, goal attainmentscale, pain measurement, treatment satisfaction, quality of life, and safetyaspects (adverse events).
In several clinical trials to date, ITB Therapy has been shown to providea positive impact on the lives of post-stroke patients by reducing spasticityand increasing quality of life .[8,10] In other trials, 89 percent ofpatients with severe spasticity have seen a reduction spasticity-relatedpain.[11] In multiple sclerosis and spinal injury, patients experienced a 92percent decrease in their spasticity symptoms following ITB Therapy.[12]
ITB Therapy has also been shown to improve mobility, daily functioningand quality of life, to ease patients' pain and decrease dependency onnursing care.[10,13] ITB Therapy has been shown to minimize the economicburden of spasticity, [13] by helping physicians and caregivers improvefunction and comfort in patients. [11]
Some patients may experience ITB therapy drug side effects which areusually temporary and manageable by adjusting the dose. The most common sideeffects include loose muscles, drowsiness, nausea/vomiting, headache anddizziness. Close attention to physician's instructions is required sinceabrupt cessation of intrathecal baclofen can result in high fever, alteredmental status, returned spasticity, and muscle rigidity, and in rare caseshas been fatal. The implanted infusion system may result in complicationssuch as infection (including meningitis), overdose or underdose resultingfrom programming errors or system component failures and cerebral spinalfluid leakage resulting in a spinal headache.
To date, ITB Therapy has been widely used to treat spasticity which couldnot be sufficiently controlled with oral medications in over 15,000 patientsin Western Europe, including people with cerebral palsy and multiplesclerosis.[14]
For important safety information, please go tohttp://www.medtronic.eu/your-health/stroke/safety-information/index.htm.
In the US, prescribing information is available athttp://professional.medtronic.com/interventions/intrathecal-baclofen-therapy/indications-safety-and-warnings/index.htm.
(Due to the length of these URLs, it may be necessary to copy and pastethis hyperlink into your Internet browser's URL address field. Remove thespace if one exists.)
About Medtronic
Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis,is the global leader in medical technology - alleviating pain, restoringhealth, and extending life for millions of people around the world.
This press release contains forward-looking statements related to resultsof Medtronic's operations, which are subject to risks and uncertainties, suchas competitive factors, difficulties and delays inherent in the development,manufacturing, marketing and sale of medical products, government regulationand general economic conditions and other risk and uncertainties described inMedtronic's periodic reports on file with the Securities and ExchangeCommission. Actual results may differ materially from anticipated results.Medtronic does not undertake to update its forward-looking statements. Unlessotherwise noted, all comparisons made in this news release are on an "asreported basis," not on a constant currency basis, and references toquarterly figures increasing or decreasing are in comparison to the thirdquarter of fiscal year 2009.
References ---------------------------------
[1] Sommerfeld DK. et al. Spasticity after stroke: its occurrence andassociation with motor impairments and activity limitations. Stroke. 2004.35(1):134-140.
[2] Watkins CL. et al. Prevalence of spasticity post stroke. ClinicalRehabilitation. 2002. August 16(5):515-22.
[3] Gelber DA. et al. Open-label dose-titration safety and efficacy studyof tizanidine hydrochloride in the treatment of spasticity associated withchronic stroke. Stroke. 2001. 32(8):1841-1846.
[4] Francisco GE et al. Consensus panel guidelines for the use ofintrathecal baclofen therapy in poststroke spastic hypertonia. Top StrokeRehabil. 2006;13(4):74-85.
[5] The World Health Organisation: Atlas of Heart Disease and Stroke2004. Available from:http://www.who.int/cardiovascular_diseases/resources/atlas/en/
[6] Truelsen T. et al. Stroke incidence and prevalence in Europe: areview of available data. Eur J Neurol. 2006. 13(6):581-598.
[7] Welmer AK. et al. Spasticity and its association with functioning andhealth-related quality of life 18 months after stroke. Cerebrovasc Dis.2006;21(4):247-53.
[8] Ivanhoe CB, et al. Intrathecal baclofen management of poststrokespastic hypertonia: implications for function and quality of life. Arch PhysMed Rehabil. 2006. 87(11):1509-15.
[9] Penn RD, et al. Intrathecal baclofen for severe spinal spasticity.New England Journal of Medicine 1989;320:1517-21
[10] Meythaler JM, et al. Intrathecal baclofen for spastic hypertoniafrom stroke. Stroke. 2001. 32(9):2099-109
[11] Sampson FC et al. Functional benefits and cost/benefit analysis ofcontinuous intrathecal baclofen infusion for the management of severespasticity. J of Neurosur 2002; 96(6): 1052-1507.
[12] Creedon SD, et al. Intrathecal baclofen for severe spasticity: ameta-analysis. Int J Rehabil Health 1997; 3(3):171-85.
[13] Bensmail D. et al. Cost-effectiveness modeling of IntrathecalBaclofen Therapy Versus Other Interventions for Disabling Spasticity.Neurohabil Neural Repair. 2009. Febr. 1-7
[14] Medtronic data on file
SOURCE Medtronic Inc.
