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Title: New Evidence Demonstrates Use of Stalevo Improves Quality of Life and May Provide Long-Term Benefits in Patients With Parkinson's Disease

"New Evidence Demonstrates Use of Stalevo Improves Quality of Life and May Provide Long-Term Benefits in Patients With Parkinson's Disease"

First quality of life study with Stalevo - enhanced levodopa therapy - shows significant improvements in control of Parkinson's disease symptoms 1 Earlier initiation of enhanced levodopa therapy could provide benefits that cannot be achieved if treatment is delayed 2 Parkinson's disease - 6.3 million people affected worldwide3 - shortens life expectancy and causes significant decline in the quality of life 4 KYOTO, JAPAN -- November 1, 2006 -- New data shows that Stalevo* significantly improves quality of life in patients with Parkinson's disease with no or minimal motor fluctuations, when compared to traditional levodopa therapy. In addition, new analysis suggests that patients treated earlier with enhanced levodopa therapy including entacapone experienced a sustained improvement in symptom control that was not achieved when treatment was delayed by 6 months. The new findings were presented today at the 10th International Congress of Movement Disorders Society (MDS) of Parkinson's Disease in Kyoto, Japan. "These data provide important insight into the management of Parkinson's disease and again highlights the benefits that earlier treatment initiation may provide" said Anthony Schapira, Department of Clinical Neurosciences, Royal Free Hospital, London. "The results presented today show that enhanced levodopa therapy can significantly improve quality of life and symptom control in Parkinson's disease patients. The results from the earlier initiation of enhanced levodopa therapy are of great interest and should stimulate further research in this area." Parkinson's disease is a progressive and degenerative neurological disease4 for which there is currently no cure; it affects all cultures and races, with an estimated worldwide prevalence of 6.3 million people.3 The QUEST-AP (QUality of Life Evaluation of STalevo Asia Pacific) is the first double blind study of its kind to compare the effect of Stalevo to traditional levodopa on QoL in PD patients with no or minimal, non-disabling motor fluctuations. The study has been conducted in collaboration between MDS Australia Clinical Research & Trial Group and Novartis Australia and demonstrates that - even after only 12 weeks of treatment - Stalevo significantly improves QoL compared to traditional levodopa therapy, including emotional wellbeing, communication, social relationship and stigma. "The results of the study are very exciting for people with Parkinson's and their families alike. PD can be devastating, yet the data presented today shows that Stalevo can really help improve the emotional and social aspects of Parkinson's disease" commented Mary Baker, Patron and Immediate Past President of the European Parkinson's Disease Association (EPDA). "The data offers genuine hope and demonstrates that patients may continue to enjoy good quality of life despite having PD." A further pooled analysis of three double-blind phase 3 studies5,6,7, suggests that levodopa-treated patients who received earlier the enhanced levodopa therapy with entacapone, experienced immediate benefits which were sustained for up to five years. During the five year period, patients whose treatment was delayed by 6 months were unable to catch up with the better symptom control achieved in the earlier start patients. Together, this study and analysis suggest that earlier initiation of an optimized therapy not only could provide better quality of life for Parkinson's patients, but that delaying the initiation of an optimized levodopa therapy may limit the ultimate benefits that patients could achieve both in the short and long term. The QUEST-AP Study The QUEST-AP1 study was a randomized, double blind, parallel-group, multinational study comparing the effect on quality of life of Stalevo with traditional levodopa therapy in 184 Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. It is the first study to use QoL as a primary outcome measure in PD demonstrating improved QoL in PD patients. Patients were enrolled between July 2005 and March 2006 at 10 sites in Australia, 3 sites in Taiwan, 4 sites in Thailand and 2 sites in the Philippines. The primary outcome measure was QoL as assessed by the Parkinson's Disease Questionnaire (PDQ-8), an abbreviated QoL questionnaire. Secondary outcome measures were the Unified PD Rating Scale (UPDRS) also including the measurement of daily life activities. The results demonstrates that Stalevo improves significantly several aspects of functioning and well-being which adversely affect patients with Parkinson's disease. The results show that patients on Stalevo had a significant improvement in their PDQ-8 score (p=0.021). The treatment effect of Stalevo was particularly significant for emotional wellbeing, social relationships, communication and stigma of the PDQ-8. In addition, Stalevo therapy resulted in superior improvements at week 12 in activities of daily life (ADL). Enhanced levodopa therapy: early vs. delayed start analysis Earlier treatment with enhanced levodopa with entacapone therapy also showed to be beneficial when compared to traditional levodopa according to an analysis on 488 patients.2 The five-year retrospective analysis evaluated the effect of early vs. delayed start with enhanced levodopa therapy on long-term efficacy (5 years) in PD patients already receiving PD medication. Earlier initiation of enhanced levodopa therapy in comparison to traditional levodopa therapy resulted in, and maintained, superior symptom control over 5 years, compared with a delayed-start therapy regimen, as assessed by the UPPDRS motor scale.(P <.05). Consistent with these results, when adjusted for the duration of PD at baseline, the group difference in UPDRS III scores was even more significant (p<0.001). The analysis suggests that earlier introduction of enhanced levodopa therapy in patients treated with traditional levodopa therapy provides benefit that cannot be achieved if treatment is delayed. About Stalevo Stalevo (levodopa/carbidopa/entacapone) is an enhanced levodopa therapy for the treatment of Parkinson's disease indicated for those patients experiencing wearing-off motor complications. Stalevo contains both a DDC inhibitor (carbidopa) and a COMT inhibitor (entacapone) that prevent the breakdown of levodopa and so provide a smoother and more continuous supply of levodopa to the brain. Levodopa replaces the dopamine missing in PD but before it reaches the brain it is extensively metabolized in the periphery. Stalevo provides enhanced symptom control throughout the day vs traditional levodopa and the efficacy of Stalevo is maintained during long-term treatment. Stalevo, developed by Orion Corporation Orion Pharma, is marketed by Novartis and Orion Pharma in their respective territories. About Parkinson's disease Parkinson's disease is a chronic and progressive neurological condition that affects 6.3 million people worldwide. While their cause is unknown, PD symptoms are primarily the result of a degeneration of dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement. Symptoms include limbs that tremble, slowness of movement, stiffness and rigidity of limbs and gait or balance problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and function. REFERENCES: 1. Movement Disorder Society of Australia Clinical Research & Trial Group and QUEST-AP Study Group. A randomized, double-blind study to compare the effect on quality of life of levodopa/carbidopa/entacapone (Stalevo®) with levodopa/carbidopa in patients with Parkinson's disease with no or minimal, non disabling motor fluctuations presented at Movement Disorders Society's 10th International Congress of Parkinson's Disease and Movement Disorders in Kyoto, Japan. Poster 4372. 2. Nissinen H, Kuoppamaki M, Leinonen M. Early vs. delayed initiation of levodopa/DCCI/entacapone leads to superior 5-year efficacy in Parkinson's disease patients, initially receiving traditional levodopa/DCCI therapy. Poster presented at Movement Disorders Society's 10th International Congress of Parkinson's Disease and Movement Disorders in Kyoto, Japan. Abstract 520 3. EPDA Website: http://www.epda.eu.com/patientGuide/LWP_1_01_whatIsPD.shtm last accessed 16.10.06 4. Anthony H. Timing of treatment initiation in Parkinson's disease. A need for reappraisal? Annals of Neurology. Feb 2006; 559-562. 5. Rinne UK, Larsen JP, et al. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology 1998; 51 (5): 1309-14. 6. PSG. Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Parkinson Study Group. Ann Neurol. 1997; 42(5): 747-55. 7. Poewe WH, Deutschl G, et al. Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal levodopa response: a 6 month randomized placebo-controlled double blind study in Germany and Austria (Celomen study). Acta Neurol Scand 2002; 105 (4): 245-55. 8. Larsen JP, Worm-Petersen J, et al. The tolerability and efficacy of entacapone over 3 years in patients with Parkinson's disease. Eur J Neurol 2003; 10 (2): 137-46. 9. Stocchi F. When and how to administer levodopa. Focus on Parkinson's disease 2006;18 (1): 2-4. 10. Olanow CW, Obeso JA and Stocchi F. Continuous dopamine-receptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol 2006; 5: 677-87. 11. Poewe WH, Deuschl G, Gordin A, et al. Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study). Acta Neurol Scand. 2002;105:245-255. 12. Brooks DJ, Sagar H, and the UK-Irish Entacapone Study Group. Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study. J Neurol Neurosurg Psychiatry. 2003;74:1071-1079. 13. Rinne UK, Larsen JP, Sidén Å, Worm-Petersen J, and the Nomecomt Study Group. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Neurology. 1998;51:1309-1314. 14. Parkinson Study Group. Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Ann Neurol. 1997;42:747-755. 15. Larsen JP, Worm-Petersen J, Sidén Å, Gordin A, Reinikainen K, Leinonen M, and the NOMESAFE Study Group. The tolerability and efficacy of entacapone over 3 years in patients with Parkinson's disease. Eur J Neurol. 2003;10:137-146. SOURCE: Novartis

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