The FIRST STEP study, presented today at the American Academy of Neurology Annual Meeting in Chicago, is intended to support regulatory filings in 2008 for the use of Stalevo in patients with early Parkinson's disease (PD) who have not been treated with levodopa.
"It is important to provide effective therapeutic options for patients with early PD, and levodopa/carbidopa has been considered the most effective treatment for motor symptoms," said Robert A. Hauser, MD, Professor of Neurology, Pharmacology and Experimental Therapeutics at the University of South Florida, and principal investigator of the study. "The results of FIRST STEP indicate that Stalevo may provide greater benefits for patients with early Parkinson's disease over and above levodopa/carbidopa therapy."
Stalevo is currently indicated for certain Parkinson's disease patients who experience end-of-dose motor (or movement) fluctuations, known as "wearing off". This occurs when the dose of levodopa that initially controlled their symptoms is no longer enough to maintain full control until the next dose.
In the FIRST STEP study in patients with early Parkinson's disease, Stalevo showed a statistically significant improvement versus levodopa/carbidopa in the primary endpoint, which was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II-activities of daily living (eating, bathing, dressing) and Part III-motor scores (agility, rigidity, tremors) (p=0.045).
FIRST STEP (Favorability of Immediate-Release carbidopa/levodopa vs STalevo; Short-Term comparison in Early Parkinson's) was a double-blind, randomized, parallel group, fixed-dose clinical trial that included 423 patients with early Parkinson's disease in eight countries.
"This study is part of a research initiative to better understand the potential of Stalevo in the treatment of patients with early Parkinson's disease," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "The results of FIRST STEP demonstrate the potential for Stalevo to provide benefits for an even greater number of patients suffering from this often devastating disease."
Parkinson's disease is a chronic, progressive disorder of the nervous system, which causes increasing disability over time and affects approximately 6.5 million people worldwide. The condition is diagnosed by the appearance of movement-related or 'motor' symptoms including tremor, muscular rigidity, stooped posture and slowness or difficulty in movement.
Stalevo is an optimized levodopa therapy combining levodopa and carbidopa with the enzyme inhibitor entacapone, which extends the presence of levodopa in the bloodstream. It was approved by the US Food and Drug Administration in June 2003 and by the European Commission in October 2003, and is now approved in 79 countries. Stalevo is developed and manufactured by Orion Corporation, and is marketed by Novartis and Orion in their respective territories.
The most common side effects of Stalevo are unwanted or uncontrollable movements (known as dyskinesia), nausea, diarrhea, excessive muscle movements (known as hyperkinesia), harmless discoloration of urine, sweat and/or saliva; diminished or slow movements (known as hypokinesia), abdominal pain, dizziness, constipation, fatigue, pain, and hallucinations. Some of the more serious side effects may include severe diarrhea, severe dyskinesia, hallucinations, other mental disturbances, orthostatic hypotension (low blood pressure), rhabdomyolysis (a muscle disease), and symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness).
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 Hauser RA, Panisset M, Abbruzzese G, et al. Improved symptom control with fixed dose levodopa/carbidopa/entacapone (Stalevo®) versus conventional levodopa/carbidopa as first-line levodopa therapy in early Parkinson's disease patients. From abstract; poster to be presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
 Stalevo Prescribing Information.
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 Thanvi B et al. Long term motor complications of levodopa: clinical features, mechanisms, and management strategies. Postgrad Med J 2004; 80: 452-458.
 NIH. Medical Encyclopedia. http://www.nlm.nih.gov/medlineplus/ency/article/000755.htm.
 National Parkinson Foundation. Parkinson Primer. http://www.parkinson.org/NETCOMMUNITY/Page.aspx?pid=226&srcid=225