To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Dopamine Agonist May Change Way Physicians Treat Early Parkinson's Disease URL: http://www.pslgroup.com/dg/39C72.htm Doctor's Guide September 22, 1997
PHILADELPHIA, PA. -- September 22 -- SmithKline Beecham's Requip™ (ropinirole hydrochloride) received marketing clearance today from the U.S. Food and Drug Administration (FDA) for treatment of the signs and symptoms of Parkinson's disease, both as initial therapy and as adjunctive treatment with levodopa. Unlike older dopamine agonists, Requip, which is a second generation dopamine agonist, is licensed for use in patients with early Parkinson's disease (without levodopa) and in patients with advanced Parkinson's disease (with levodopa). "Requip is a significant advancement that may change the way physicians treat this complicated disease," said Dr. Ray Watts, department of neurology, Emory School of Medicine. "Requip allows physicians to delay the use of levodopa, a drug which may be associated with severe motor fluctuations after long-term use. Now these physicians can use Requip to control symptoms early in the disease or later in combination with traditional treatments. This approach will be very valuable in the management of Parkinson's disease." Currently, levodopa is the standard treatment for Parkinson's disease. It has been proven to be very effective initially, but over time patients taking levodopa need to increase their dosage to maintain control of symptoms. "It is important to recognize the value of new treatments that can be used in the early stages of Parkinson's disease," said Emilio Alonso-Mendoza, executive director, National Parkinson Foundation, Inc. "This may mean that the disease can be treated effectively over a longer period of time, improving quality of life for patients and their families. Quality of life is an important issue in treating Parkinson's because the disease is so debilitating." Parkinson's disease, which affects between 500,000 and 1,000,000 Americans, is a chronic and progressive disorder which 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 the substantia nigra and another critical area of the brain called the striatum. Dopamine depletion results in a patient's impaired ability to control motor movements. Requip is a highly-selective second-generation dopamine agonist that works by mimicking the effects of dopamine. The effects of Requip as initial dopaminergic therapy in patients with mild to moderate Parkinson's disease were assessed in a double-blind, randomized, placebo-controlled study. Results were obtained through a measurement used by physicians to assess the disease status of Parkinson's disease patients called the Unified Parkinson's Disease Rating Scale. Physicians measured the overall change they saw in their patients' motor function. The results of this study show that patients treated with Requip (116) demonstrated a significantly superior improvement in motor score of 24 percent compared to placebo-treated patients (125) who demonstrated a three percent worsening in motor score after six months. In addition, 33 percent of patients treated with Requip were rated as either "much improved" or "very much improved" on the Clinical Global Impressions improvement item compared to 12 percent of patients given placebo. "This study shows that this new drug can improve motor function early in the disease and will therefore enable patients to maintain their active lives," Dr. Watts said. The efficacy of Requip as adjunctive therapy with levodopa in the late stages of Parkinson's disease was confirmed in a double-blind, randomized study comparing patients treated with Requip (94) to patients treated with placebo (54). Investigators evaluated the number of responders" defined as patients who were able to achieve a decrease (compared to baseline) of at least 20 percent in their levodopa dose and a decrease of at least 20 percent in the proportion of time awake in the off condition (period of time during the day when patients are particularly immobile). After six months, 28 percent of patients treated with Requip were classified as responders versus 11 percent of placebo-treated patients, a statistically significant difference. In addition, 49 percent of Requip- treated patients had their levodopa dose reduced by at least 20 percent versus 17 percent of placebo-treated patients, also statistically significant. The average levodopa dose reduction was 31 percent for patients treated with Requip. This study demonstrates the adjunctive use of Requip with levodopa allows for the reduction of a patient's levodopa dose, therefore reducing the total amount of levodopa which must be taken daily. In both early and adjunct therapy studies, Requip was generally well tolerated. In the early therapy study, the most common adverse experience was nausea, which was related to the stimulation of dopamine receptors. Other adverse experiences that occurred less frequently included dizziness, somnolence and headaches. In the adjunctive therapy study, in patients already experiencing motor fluctuations, the most common adverse experience was dyskinesia. Other adverse experiences that occurred less frequently included nausea, dizziness, and somnolence. All Parkinson's patients should be informed that syncope or symptomatic hypotension may occur more frequently during initial treatment and hallucinations can occur at any time during the course of treatment. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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