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The New England Journal Of Medicine Publishes Important Parkinson's Disease Study
Wed, May 17th 2000
PHILADELPHIA, May 17 -- SmithKline Beecham's Requip(R) (ropinirole hydrochloride) successfully managed Parkinson's disease symptoms for up to five years with a low risk of developing dyskinesia, according to a study published today in The New England Journal of Medicine. Dyskinesias are severe, uncontrollable, jerky body movements that plague many Parkinson's disease patients and in many cases are associated with levodopa therapy.
Levodopa has been the "gold standard" of treatment in Parkinson's disease for the past 35 years; it is used in approximately 75 percent of patients. Unfortunately, over time Parkinson's disease progresses and physicians need to increase the dosage and frequency of levodopa to relieve Parkinson's symptoms. Increasing the dosage of levodopa can cause many patients to experience levodopa-induced side effects such as dyskinesias, which can have a negative impact on a patient's ability to function. This study confirms that Requip, alone or in combination with low dose levodopa, is effective in managing early Parkinson's disease (Hoehn & Yahr disease stages I-III).
"The impact of this study is that it will help guide physicians to chose among a number of Parkinson's disease treatments for early management in order to minimize the long-term side effects of treatment. And it indicates that if you use Requip first, you are less likely to get dyskinesias over the course of five years," said lead study author Olivier Rascol, M.D., Ph.D. of the Centre Hospitalier Universitaire Toulouse, France. "I think these results will impact physicians' treatment strategy to help improve the daily lives of patients coping with Parkinson's disease."
Requip Effective Long-Term Therapy
In a double-blind, parallel-group study, 268 patients with early Parkinson's disease were randomized (in a 2 to 1 ratio) to receive either Requip or levodopa, and were evaluated for five years. Patients in both the Requip and levodopa groups who required additional symptomatic relief were given supplemental, open-label levodopa.
Of those enrolled, 130 patients completed the study (n=85 Requip, n=45 levodopa). Requip was effective in treating Parkinson's disease and patients on Requip had a low risk of developing dyskinesia. Sixty-four percent of patients on levodopa and 34 percent of patients who received Requip completed the five-year study without supplemental levodopa therapy.
Regardless of levodopa supplementation, 20 percent of patients receiving Requip and 45 percent of patients receiving levodopa developed dyskinesia. The incidence of developing disabling dyskinesia was 8 percent in the Requip group and 23 percent in the levodopa group. In addition, patients taking Requip alone were seven times more likely to remain dyskinesia-free than patients taking levodopa alone. The average dosage of Requip at the end of the five-year study was 16.5mg/day. Requip patients requiring levodopa supplementation were maintained on a low daily dose of levodopa (427 mg).
Requip is generally well tolerated. The most commonly reported side effects are nausea, somnolence, dizziness, headache and dyskinesia. Patients are advised to talk to their doctor about whether they have the potential to develop the sedating effects associated with Requip, which include somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Fainting or low blood pressure may occur during initial treatment or with an increase in dose. Hallucinations may occur at anytime during treatment. Requip may potentiate the side effects of L-dopa.
"The data confirm Requip's efficacy in the early stages of the disease with a low risk of developing dyskinesia and provide strong evidence in support of starting early Parkinson's disease patients on a dopamine agonist, such as Requip," said Ray Watts, M.D., Director of the Movement Disorders Program at Emory University School of Medicine. "A study is currently underway to determine if early treatment with Requip can have an effect on dopamine cell loss, which may be helpful in furthering our understanding of the progression of Parkinson's disease. Together, these studies may provide neurologists with a deeper understanding of how to optimally treat this condition."
Requip is a second-generation dopamine agonist indicated for the treatment of the signs and symptoms of both early and advanced stages of Parkinson's disease and was approved by the U.S. Food and Drug Administration (FDA) in September 1997.
A Progressive Neurodegenerative Disorder
Parkinson's disease, which affects between 500,000 and one million Americans, is a chronic and progressive disorder that results from the death of nerve cells in a critical area of the brain called the substantia nigra. These nerve cells normally produce dopamine, a chemical messenger that plays an important role in motor movement control by transmitting signals between different areas of the brain. Increasing the dosage of levodopa can cause many patients to experience levodopa-induced side effects such as dyskinesias, which can have a negative impact on a patient's ability to function. Dopamine depletion results in a patient's impaired ability to control motor movements.
"Parkinson's disease affects nearly one million Americans, including Michael J. Fox, Janet Reno and Muhammad Ali," said Abraham Lieberman, M.D., Clinical Director for the National Parkinson Foundation. "If we can better treat the condition in the early stages, patients may be able to live more active lives. While searching for a cure to this disease, our hope is to better manage patients who are living with it now."
A Leader in Health Care
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing and disease management. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com. For more information on Parkinson's disease and Requip, visit http://www.requip.com.
SOURCE SmithKline Beecham