 |
 |
Email to a Colleague Printable Version Publication Logo Transdermal Rotigotine Well Tolerated Through 18 Months of Treatment October 11, 2006 (Chicago) — A once-daily treatment of the investigative dopamine agonist rotigotine (Neupro, Schwarz Pharma) in a transdermal patch is associated with sustained benefits and is well tolerated as a monotherapy in Parkinson's disease, according to investigators who presented their findings here at the American Neurological Association (ANA) 131st Annual Meeting. In an 18-month study, the investigators found that "the rotigotine transdermal patch was generally safe and well tolerated, with a low rate of discontinuance due to adverse effects," principal investigator Ray L. Watts, MD, chair of the department of neurology at the University of Alabama at Birmingham, said in a presentation. "We think that use of the patch can help a person with early-stage Parkinson's disease [delay using] levodopa for 2 to 3 years," he said. In 1 of the 6-month trials used in the analysis, researchers demonstrated that rotigotine was superior to placebo in preventing symptoms of Parkinson's disease in patients. In the current research, which focused on safety and tolerability, the investigators pooled data from 3 double-blind, placebo-controlled trials of rotigotine. The combined trials involved 938 patients in the initial titration phase. The patients had early Parkinson's disease as measured by Hohn and Yahr scores of less than 3 and at least 2 motor symptoms associated with Parkinson's disease, such as bradykinesia, resting tremor, rigidity, or postural instability. Among these patients, 289 were on placebo and 648 were on active treatment. The doses in the transdermal patches, which were changed every 24 hours, were 2, 4, 6, or 8 mg, depending on the dose to which the patient was randomized. Once the optimal dose was reached and the maintenance phase began, 250 patients were on placebo and 604 were on active treatment. In the titration phase, adverse events were documented in 74% of patients in the rotigotine groups and 64% in the placebo group. In the maintenance phase, the overall incidence of adverse events was 62% in the rotigotine groups and 64% in the placebo group. Adverse events that resulted in discontinuation occurred in 13% of patients on treatment and in 6% of those on placebo. The most common adverse events in the titration phase, comparing active treatment with placebo, respectively, were: Nausea, in 35% and 12%. Application-site reaction, in 23% and 9%. Dizziness, in 14% and 6%. Vomiting, in 10% and 1%. Insomnia, in 6% and 3%. In the maintenance phase, fewer patients experienced adverse effects, the investigators reported. These were, in treatment and placebo groups, respectively: Nausea, in 8% and 4%. Application-site reaction, in 19% and 6%. Dizziness, in 6% and 5%. Vomiting, in 4% and 1%. Insomnia, in 4% and 2%. Application-site reactions were primarily mild or moderate in severity, Dr. Watts said. Noting the efficacy of treatment, Dr. Watts pointed out, "There was a low risk of dyskinesia with long-term administration of rotigotine. This finding may be consistent with its stable 24-hour blood plasma levels when administered through a transdermal patch." Although more patients on treatment experienced adverse effects than did those on placebo, patients tend to tolerate the medicine very well, said Dr. James Patton, a neurologist with Asheville Neurology Specialists, a private practice company in North Carolina that also conducts pharmaceutical research, who was not involved in the current study. "This is an exciting drug," Dr. Patton said. "It has good patient tolerance. It's very safe. The patients' laboratory tests didn't cause any treatment-related discontinuations." "What makes the patch so good is that it delivers medicine continuously," said Jeanne Rosner in a separate interview. She is the director of the Parkinson's Information Service in Chicago, Illinois, which is a division of the Parkinson's Disease Foundation. "Patients don't have to worry about when they have to take their drugs. They just put the patch on and go about their business." She added that eventually, patches might prove to be better than standard treatments by eliminating the stress on the body of going on and off medication. "We don't know that for a fact yet," she said, "but it is something we think may be happening to patients, and why after awhile some of these medications lose potency in controlling the disease." These benefits offset the application-site reactions that often occur with transdermal delivery systems and the rotigotine-associated adverse effects, she said. The study was funded by Schwarz Pharma, in Monheim, Germany, which is developing Neupro. ANA 131st Annual Meeting: Abstract T-48. Presented October 10, 2006. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn