PMID- 20920156
OWN - NLM
STAT- MEDLINE
DCOM- 20110106
LR  - 20211020
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 10
DP  - 2010 Sep 28
TI  - Treatment of moderate to severe restless legs syndrome: 2-year safety and 
      efficacy of rotigotine transdermal patch.
PG  - 86
LID - 10.1186/1471-2377-10-86 [doi]
AB  - BACKGROUND: Rotigotine is a unique dopamine agonist with activity across D1 
      through D5 receptors as well as select adrenergic and serotonergic sites. This 
      study reports the 2-year follow-up safety and efficacy data of an ongoing 
      open-label multicenter extension study (NCT00498186) of transdermal rotigotine in 
      patients with moderate to severe restless legs syndrome (RLS). METHODS: Patients 
      received a once-daily patch application of an individually optimized dose of 
      rotigotine between 0.5 mg/24 h to 4 mg/24 h. Safety assessments included adverse 
      events (AEs) and efficacy was measured by the International RLS Study Group 
      Severity Rating Scale (IRLS), RLS-6 scales and Clinical Global Impression (CGI). 
      Quality of life (QoL) was measured by QoL-RLS. RESULTS: Of 310 patients who 
      completed a 6-week placebo-controlled trial (SP709), 295 (mean age 58 +/- 10 years, 
      66% females) were included in the open-label trial SP710. 64.7% (190/295 
      patients) completed the 2-year follow-up; 29 patients discontinued during the 
      second year. Mean daily rotigotine dose after 2 years was 2.93 +/- 1.14 mg/24 h 
      with a 2.9% dose increase from year 1. Rotigotine was generally well tolerated. 
      The rate of typical dopaminergic side effects, nausea and fatigue, was low (0.9% 
      and 2.3%, respectively) during the second year; application site reactions were 
      frequent but lower than in year 1 (16.4% vs. 34.5%). The IRLS total score 
      improved from baseline of SP709 (27.8 +/- 5.9) by 17.2 +/- 9.2 in year 2 completers. 
      Similar improvements were observed in RLS-6 scales, CGI scores and QoL-RLS. The 
      responder rate in the CGI change item 2 ("much" and "very much" improved) was 95% 
      after year 2. CONCLUSIONS: Transdermal rotigotine is an efficacious and 
      well-tolerated long-term treatment option for patients with moderate to severe 
      RLS with a high retention rate during 2 years of therapy. TRIAL REGISTRATION: 
      NCT00498186.
FAU - Hogl, Birgit
AU  - Hogl B
AD  - Department of Neurology, Innsbruck Medical University, Innsbruck, Austria. 
      birgit.ho@i-med.ac.at
FAU - Oertel, Wolfgang H
AU  - Oertel WH
FAU - Stiasny-Kolster, Karin
AU  - Stiasny-Kolster K
FAU - Geisler, Peter
AU  - Geisler P
FAU - Benes, Heike
AU  - Benes H
FAU - Garcia-Borreguero, Diego
AU  - Garcia-Borreguero D
FAU - Trenkwalder, Claudia
AU  - Trenkwalder C
FAU - Poewe, Werner
AU  - Poewe W
FAU - Schollmayer, Erwin
AU  - Schollmayer E
FAU - Kohnen, Ralf
AU  - Kohnen R
LA  - eng
SI  - ClinicalTrials.gov/NCT00498186
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100928
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Dopamine Agonists)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Dopamine Agonists/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance
MH  - Restless Legs Syndrome/*drug therapy
MH  - Tetrahydronaphthalenes/*administration & dosage/adverse effects
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Transdermal Patch
MH  - Young Adult
PMC - PMC2958158
EDAT- 2010/10/06 06:00
MHDA- 2011/01/07 06:00
PMCR- 2010/09/28
CRDT- 2010/10/06 06:00
PHST- 2010/05/18 00:00 [received]
PHST- 2010/09/28 00:00 [accepted]
PHST- 2010/10/06 06:00 [entrez]
PHST- 2010/10/06 06:00 [pubmed]
PHST- 2011/01/07 06:00 [medline]
PHST- 2010/09/28 00:00 [pmc-release]
AID - 1471-2377-10-86 [pii]
AID - 10.1186/1471-2377-10-86 [doi]
PST - epublish
SO  - BMC Neurol. 2010 Sep 28;10:86. doi: 10.1186/1471-2377-10-86.