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| |  Long-Term Use of Prolonged-Release Ropinirole Well Tolerated by Patients With Early or Advanced Parkinson's Disease: Presented at ENS By Judith Moser, MD MILAN, Italy -- June 25, 2009 -- Prolonged-release ropinirole appears to be well tolerated as a monotherapy or adjunct treatment for >1 year in patients with Parkinson’s disease, researchers stated here at the 19th Meeting of the European Neurological Society (ENS). In addition, the pooled analysis of the 2 studies presented showed patients prefer the once-daily dosing over 3-times-daily dosing for convenience. Heinz Reichmann, MD, Department of Neurology, University Hospital Carl Gustav Carus, Dresden, Germany, presented a planned interim update on safety and tolerability data of 2 long-term multicentre, open-label, flexible-dose extension studies (101468/196 and 101468/248) with the prolonged-release formulation of ropinirole on June 23. The researchers also presented the results of an analysis of the patients’ preferred dosing regimen. A total of 502 patients with early or advanced Parkinson’s disease received once-daily prolonged-release ropinirole 2 to 24 mg/day either as monotherapy (n = 194) or adjunct therapy (n = 357). Eighty-three percent of the patients had been exposed to treatment for >1 year. “We observed typical dopaminergic side effects, but symptoms such as hallucinations and somnolence occurred infrequently,” Dr. Reichmann emphasised. Treatment-emergent adverse events (TEAEs) were reported by 404 patients (80%), with peripheral oedema being the most common (13%). Serious TEAEs occurred in 19% of patients; chest pain (2%) and worsening of Parkinson’s disease (2 %) were reported most frequently. All other serious TEAEs occurred with a frequency <1%. Fifteen percent of patients withdrew from ropinirole treatment because of an TEAE, most commonly hallucinations (2.4 %). Four patients died, but none of the deaths was considered treatment related. In the dosing-preference study, 112 patients were enrolled. At week 4, 85% of patients preferred once-daily over 3-times-daily dosing, whereas only 15% expressed a neutral or negative opinion (P < .001). These percentages were similar at week 26 (86% vs 14%; P < .001). Reasons for preferring once-daily dosing included a lower likelihood to forget (34%), greater convenience (27%), simplicity (13%), greater efficacy (7%), and fewer side effects (5%). Ninety percent of the study patients deemed the once-daily regimen to be more convenient, and 92% thought it easier to remember than the 3-times-daily regimen. “For the future treatment of Parkinson’s disease, I believe that we will increasingly have to avoid frequent dosing,” said Dr. Reichmann. “We learned from different studies that patients confuse or forget their medications. Therefore, in the long run, patients can [benefit from] once-daily dosing, preferably in the morning.” Funding for this study was provided by GlaxoSmithKline Research and Development. [Presentation title: Long-Term Safety and Patient Preference for Dose Frequency in Patients Receiving Ropinirole Prolonged-Release in Early or Advanced Parkinson’s Disease. Abstract P483]
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