Stalevo may provide more benefit than standard therapy for early Parkinson's disease (4/18/2008)

A new study in patients with early Parkinson's disease demonstrates that Stalevo (a combination of levodopa/carbidopa/entacapone) provides better symptom control and greater improvements in activities of daily living than levodopa/carbidopa, the most widely-used current therapy.

The FIRST STEP study was presented today at the American Academy of Neurology Annual Meeting in Chicago by the study's principal investigator Robert A. Hauser, MD, professor of neurology, pharmacology and experimental therapeutics at the University of South Florida.

The new data is 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.

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 the United States, Canada and six other countries.

"It is important to provide effective therapeutic options for patients with early Parkinson's disease, and levodopa/carbidopa has been considered the most effective treatment for motor symptoms," said Dr. Hauser, director of the Parkinson's Disease and Movement Disorders Center at USF. "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 used only for certain Parkinson's disease patients who experience end-of-dose fluctuations in movement, known as "wearing off." This occurs when the dose of levodopa/carbidopa that initially controlled their symptoms is no longer enough to maintain full control until their next scheduled dose. The symptom re-emergence that accompanies wearing off may make it difficult for patients to perform even the most basic functions, such as walking and dressing.

Among patients with early Parkinson's disease, Stalevo showed a statistically significant improvement compared to levodopa/carbidopa in the primary endpoint, which was the combined Unified Parkinson's Disease Rating Scale (UPDRS) comprised of Part II-activities of daily living (eating, bathing, dressing) and Part III-motor scores (agility, rigidity, tremors).

"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."

Approximately 6.5 million people worldwide suffer from Parkinson's disease, a progressive and disabling neurological condition. 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. Originated and manufactured by Orion Corporation, Stalevo was approved by the U.S. Food and Drug Administration in June 2003 and is marketed in the United States by Novartis Pharmaceuticals Corporation. It is now approved in 79 countries.

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).

Note: This story has been adapted from a news release issued by the University of South Florida

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