PMID- 22326237
OWN - NLM
STAT- MEDLINE
DCOM- 20121012
LR  - 20180228
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 18
IP  - 5
DP  - 2012 Jun
TI  - Long-term safety and tolerability of rotigotine transdermal system in patients 
      with early-stage idiopathic Parkinson's disease: a prospective, open-label 
      extension study.
PG  - 488-93
LID - 10.1016/j.parkreldis.2012.01.008 [doi]
AB  - PURPOSE: This prospective, open-label extension (SP702; NCT00594165) of a 6-month 
      double-blind, randomized study investigated the long-term safety and tolerability 
      of rotigotine transdermal system in early Parkinson's disease (PD). METHODS: 
      Patients with early-stage idiopathic PD received transdermal rotigotine for up to 
      6 years at optimal dose (up to 16 mg/24h). Adjunctive levodopa was allowed. 
      Primary outcomes included adverse events (AEs) and extent of rotigotine exposure. 
      Other outcomes included time to levodopa, incidence of dyskinesias, and efficacy 
      using the Unified Parkinson's Disease Rating Scale (UPDRS) II+III total score. 
      RESULTS: Of 217 patients entering the open-label study, 47% were still in the 
      study upon closure; 24% withdrew because of AEs and 6% because of lack of 
      efficacy. The median exposure to rotigotine was 1910 days ( approximately  5 years, 3 months; 
      range 1-2188 days). Most common AEs were somnolence (23% per patient-year), falls 
      (17%), peripheral edema (14%), nausea (12%), and application site reactions 
      (ASRs; 12%). 3% withdrew because of ASRs. 26% patients did not initiate levodopa; 
      of those who did, fewer than half started levodopa in the first year. Dyskinesias 
      were reported by 25% patients; the majority (83%) reported their first episode 
      after initiating levodopa. Mean UPDRS II+III total scores remained below 
      double-blind baseline for up to 2 years of open-label treatment. CONCLUSION: This 
      is the longest interventional study of rotigotine conducted to date. Transdermal 
      rotigotine was generally well tolerated for up to 6 years; AEs reported were 
      similar to those observed in shorter studies and led to discontinuation in only 
      24% patients.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Elmer, Lawrence W
AU  - Elmer LW
AD  - Department of Neurology, Parkinsons Disease and Movement Disorders Program, 
      Center for Neurological Health, College of Medicine, University of Toledo, 3000 
      Arlington Avenue, MS 1195, Toledo, OH 43614 2598, USA. lawrence.elmer@utoledo.edu
FAU - Surmann, Erwin
AU  - Surmann E
FAU - Boroojerdi, Babak
AU  - Boroojerdi B
FAU - Jankovic, Joseph
AU  - Jankovic J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120210
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Dopamine Agonists)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Dopamine Agonists/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Severity of Illness Index
MH  - Tetrahydronaphthalenes/*administration & dosage/adverse effects
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Treatment Outcome
EDAT- 2012/02/14 06:00
MHDA- 2012/10/13 06:00
CRDT- 2012/02/14 06:00
PHST- 2011/08/16 00:00 [received]
PHST- 2011/12/14 00:00 [revised]
PHST- 2012/01/12 00:00 [accepted]
PHST- 2012/02/14 06:00 [entrez]
PHST- 2012/02/14 06:00 [pubmed]
PHST- 2012/10/13 06:00 [medline]
AID - S1353-8020(12)00026-0 [pii]
AID - 10.1016/j.parkreldis.2012.01.008 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 
      10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.