Introduction: Rotigotine, a non-ergolinic dopamine-receptor agonist, is currently approved as monotherapy in early idiopathic Parkinson's disease (IPD), in moderate to severe idiopathic restless legs syndrome (RLS) and as adjunct therapy to levodopa in advanced IPD. Randomized, double-blind, placebo-controlled, as well as open-label studies were conducted in IPD and RLS patients to evaluate the efficacy, tolerability and safety of rotigotine in dosages up to 16 mg/24 h. Overall, these trials have shown that rotigotine has a similar adverse event (AE) profile as other non-ergolinic dopamine agonists such as pramipexole or ropinirole, inducing typical dopaminergic effects like nausea, daytime somnolence, peripheral edema or impulse control disorders. In addition, the most common AE seen with transdermal delivery of rotigotine are local skin reactions, which may lead to a treatment discontinuation in approximately 8% of patients.
Areas Covered: This review outlines Phase II and III trials that were published between 2003 and 2011. The focus of this review is on the safety profile of rotigotine but it also goes into detail about clinical trial data, pharmacokinetics and pharmacodynamics.
Expert Opinion: The emergent safety profile is similar to other non-ergolinic dopamine agonists. In addition, transdermal delivery is associated with local skin reactions, which are usually mild but may lead to a treatment discontinuation in a minority of patients.
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Rotigotine Transdermal Patch: A Review in Parkinson's Disease.
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Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
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Rotigotine transdermal patch (Leganto(®), Neupro(®)) is indicated for the treatment of restless legs syndrome (RLS); this article reviews the pharmacological properties of rotigotine transdermal patch and its clinical efficacy and tolerability in patients with RLS. The transdermal patch allows for a continuous, stable release of rotigotine (avoiding first-pass metabolism), which in turn leads to continuous receptor stimulation, believed to closely mimic physiological striatal dopamine receptor function. In short-term and 6-month studies, especially at the higher dosages of 2 and 3 mg/24 h, rotigotine transdermal patch was generally associated with a significantly greater improvement in IRLS total score and CGI-S total score than placebo, and rotigotine recipients were generally more likely to respond to treatment and enter remission.
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Article Synopsis
- Rotigotine, a dopamine receptor agonist delivered via a patch, is mainly broken down by certain cytochrome P-450 enzymes, specifically CYP2C19.
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Department of Epidemiology-Statistics, Fundacion Jimenez Diaz, Madrid, Spain.
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