title: Drug safety evaluation of  rotigotine.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical University Innsbruck, Department of Neurology, Anichstrasse 35, 6020 Innsbruck, Austria.
authors.forename: Fabienne Stephanie
authors.initials: FS
authors.lastname: Sprenger
authors.forename: Klaus
authors.initials: K
authors.lastname: Seppi
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
mesh_terms: D000279:Administration, Cutaneous; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D006801:Humans; D010300:Parkinson Disease / Q000188:drug therapy*; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine