Higher doses boost transdermal rotigotine response
medwireNews: Patients with early Parkinson’s disease (PD) may respond to higher doses of transdermal rotigotine than have previously been tested, suggest findings from a randomized, controlled trial.
The 90 patients assigned to receive active treatment started on patches that delivered 2 mg rotigotine per 24 hours, with this being increased over a period of 8 weeks to a maximum of 16 mg/24 hours. The 90 patients in the control group were given placebo patches, and a total of 176 patients were included in the final analysis.
Fifteen patients in the rotigotine group had dose reductions, as did four patients in the placebo group. All bar one of these reductions were made because of adverse effects, most commonly application site reactions, nausea, and vomiting.
However, during the 4-week maintenance period, all patients in the rotigotine group received at least 4 mg/24 hours, with 44 patients receiving the maximum dose.
Between baseline and the end of treatment, average Unified Parkinson’s Disease Rating Scale (UPDRS) scores (part II plus III) fell by 8.4 points in the rotigotine group, compared with 4.1 points in the placebo group, which was a significant difference. This change was driven by reductions in UPDRS part III.
“This change in the UPDRS part II and III score was greater than that observed in previous randomized controlled trials of rotigotine in patients with early stage PD,” say lead study author Yoshikuni Mizuno (Kitasato University School of Medicine, Sagamihara, Japan) and co-workers.
Previous studies have only assessed doses of up to 8 mg/24 hours in patients with early PD, they say, although higher doses have been tested in patients with advanced disease.
The proportion of patients with at least a 20% improvement in their UPDRS scores was 71.6% in the rotigotine group, compared with 40.9% in the placebo group, which was again a significant difference.
“Doses greater than 8 mg/24 hours appear to result in higher responder rates,” writes the team in Movement Disorders.
“The responder rate of 71.6% in this trial is, to our knowledge, the highest among trials of rotigotine in patients with early stage PD.”
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Eleanor McDermid, Senior medwireNews Reporter