Rotigotine May Be Helpful in Parkinson's Disease

Laurie Barclay, MD

December 16, 2003

Dec. 16, 2003 -- Transdermal rotigotine is safe, well tolerated, and improves symptoms in patients with Parkinson's disease (PD), according to the results of a randomized, double-blind, placebo-controlled trial published in the December issue of the Archives of Neurology.

"Oral dopamine agonists are effective for treating early PD," write members of the Parkinson Study Group. "Rotigotine is a dopamine agonist delivered through a silicone-based transdermal patch that is replaced every 24 hours."

In this parallel group, dose-ranging study, 242 patients with early PD received 11 weeks of treatment with patches containing either 4.5, 9.0, 13.5, or 18.0 mg of rotigotine or placebo.

Compared with the placebo group, the 13.5- and 18.0-mg groups had a dose-related improvement in the sum of the motor and activities of daily living component scores of the Unified PD Rating Scale from baseline to week 11 (placebo, 0.3 ± 7.7; 13.5 mg, 5.1 ± 7.0, P = .001; 18.0 mg, 5.3 ± 7.0, P < .001).

Adverse events reported more often in the rotigotine groups than in the placebo group were nausea, reactions at the patch site, dizziness, insomnia, somnolence, vomiting, and fatigue. The authors suggest that application site reactions may have been increased by the study requirement that patches be applied only to the abdomen, and that these reactions could be reduced by rotating application sites.

Potential advantages of transdermal delivery include ease of administration to patients unable to swallow, lack of effect on food intake or gastric emptying, convenient once-daily dosing, and maintenance of constant blood levels.

"This potentially could lower the long-term risk of developing motor fluctuations or dyskinesias and could make rotigotine beneficial for smoothing out motor fluctuations in patients with advanced PD," the authors write. "Future studies of rotigotine are warranted to further define its role in the treatment of motor fluctuations in levodopa-treated patients with more advanced PD and also to determine its potential in patients with early PD for reducing the incidence of motor complications compared with levodopa and orally administered dopamine agonists."

Schwartz Pharma, Inc., supported this study. The authors report no financial conflicts of interest.

Arch Neurol. 2003;60:1721-1728

Reviewed by Gary D. Vogin, MD