Rotigotine transdermal patch: in restless legs syndrome.
Rotigotine is a non-ergolinic dopamine receptor agonist, formulated as a silicone-based transdermal patch, which has been evaluated for use in the treatment of adults with moderate to severe restless legs syndrome (RLS). Transdermal rotigotine improved the symptoms of RLS in two well designed 6-month trials in adults with idiopathic, moderate to severe RLS. Rotigotine (1-3 mg/24 h in one study and 2 or 3 mg/24 h in the other) decreased the International RLS Study Group Severity Rating Scale (IRLS) sum score and the Clinical Global Impression (CGI) item-1 assessment (severity of symptoms) from baseline (co-primary endpoints) to a significantly greater extent than placebo. Over half of rotigotine recipients were classified as treatment responders according to the IRLS sum score and CGI item-1 and item-2 ratings. Improvements in RLS symptoms have been maintained in the long term with rotigotine, according to the 3-year results of an open-label extension trial. Transdermal rotigotine was generally well tolerated in clinical trials and long-term extension studies in patients with moderate to severe RLS. There was a low risk of augmentation (i.e. intensification of RLS symptoms) with rotigotine, although further evaluations are required to ascertain if continuous dopaminergic stimulation has the effect of limiting or preventing augmentation.
Baldwin
Claudine M
CM
Wolters Kluwer Health | Adis, Auckland, New Zealand. demail@adis.co.nz
Keating
Gillian M
GM
D000279:Administration, Cutaneous; D002986:Clinical Trials as Topic; D018491:Dopamine Agonists / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004361:Drug Tolerance; D006801:Humans; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D013764:Tetrahydronaphthalenes / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013876:Thiophenes / Q000493:pharmacokinetics / Q000627:therapeutic use*
D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
Lancet Neurol. 2008 Jul;7(7):595-604
18515185
Sleep Med. 2008 Dec;9(8):865-73
18753003
Sleep Med. 2008 Mar;9(3):228-39
17553743
Sleep Med. 2003 Mar;4(2):101-19
14592341
Clin Pharmacokinet. 2007;46(10):851-7
17854234
Mov Disord. 2007 Jul 30;22(10):1451-1456
17516488
Curr Neurol Neurosci Rep. 2005 Jul;5(4):266-74
15987610
J Neural Transm (Vienna). 2007;114(8):1027-31
17431734
CNS Drugs. 2004;18(1):27-36
14731057
CNS Drugs. 2007;21(12):1039-55
18020483
Sleep Med. 2004 May;5(3):237-46
15165529
J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):143-6
11459881
Neuropsychiatr Dis Treat. 2006 Dec;2(4):421-6
19412491
Drugs. 2006;66(5):607-24
16620140
Neurology. 2006 Jul 11;67(1):125-30
16832090
Mov Disord. 2004 Dec;19(12):1432-8
15390055