PMID- 23508526
OWN - NLM
STAT- MEDLINE
DCOM- 20140318
LR  - 20211021
IS  - 1435-1463 (Electronic)
IS  - 0300-9564 (Linking)
VI  - 120
IP  - 9
DP  - 2013 Sep
TI  - The safety and tolerability of rotigotine transdermal system over a 6-year period 
      in patients with early-stage Parkinson's disease.
PG  - 1321-9
LID - 10.1007/s00702-013-1001-5 [doi]
AB  - This open-label extension (SP716; NCT00599196) of a 6-month, double-blind, 
      randomized study (SP513) investigated the safety and tolerability of rotigotine 
      transdermal system over up to ~6 years in patients with Parkinson's disease (PD; 
      early-stage PD at double-blind enrollment). Eligible patients completing the 
      6-month study received optimal dose open-label rotigotine (</= 16 mg/24 h) for up 
      to ~6 years. Adjunctive levodopa was permitted. Primary outcomes included adverse 
      events (AEs) and extent of rotigotine exposure. Analysis of adjunctive levodopa 
      use, dyskinesias [unified Parkinson's disease rating scale (UPDRS) IV], and 
      efficacy (UPDRS II + III total score) were also assessed. Of 381 patients 
      enrolled in the open-label extension, 52 % were still in the study at time of 
      closure; 24 % withdrew because of AEs and 6 % because of lack of efficacy. 
      Patients received rotigotine for a median duration of 1,564.5 days (~4 years, 3 
      months; range 5-2, 145 days). 69 % of patients started supplemental levodopa; 
      median time to levodopa was 485 days (~1 year, 4 months). Most common AEs (% per 
      patient-year) were somnolence (18 %), application site reactions (12 %), nausea 
      (9 %), peripheral edema (7 %), and fall (7 %). AEs indicative of 
      impulsive-compulsive behavior were recorded in 25 (7 %) patients. Dyskinesias 
      were experienced by 65 (17 %) patients; the majority [47 of 65 (72 %)] reported 
      first dyskinesia after starting levodopa. Mean UPDRS II + III total scores 
      remained below double-blind baseline for 4 years (assessment of all patients). In 
      conclusion, rotigotine was generally well tolerated for up to ~6 years in 
      patients with early-stage PD. The AEs reported were in line with previous studies 
      of rotigotine transdermal system, with typical dopaminergic side effects and 
      application site reactions seen.
FAU - Giladi, Nir
AU  - Giladi N
AD  - Movement Disorders Unit, Department of Neurology, Tel-Aviv Sourasky Medical 
      Center, Sackler School of Medicine, Tel-Aviv University, 6 Weizmann Street, 
      64239, Tel-Aviv, Israel. nirg@tlvmc.gov.il
FAU - Boroojerdi, Babak
AU  - Boroojerdi B
FAU - Surmann, Erwin
AU  - Surmann E
LA  - eng
SI  - ClinicalTrials.gov/NCT00599196
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130319
PL  - Austria
TA  - J Neural Transm (Vienna)
JT  - Journal of neural transmission (Vienna, Austria : 1996)
JID - 9702341
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 46627O600J (Levodopa)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
MH  - Adolescent
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiparkinson Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Dyskinesia, Drug-Induced/epidemiology
MH  - Electrocardiography/drug effects
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Levodopa/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Prospective Studies
MH  - Survival Analysis
MH  - Tetrahydronaphthalenes/administration & dosage/*adverse effects/therapeutic use
MH  - Thiophenes/administration & dosage/*adverse effects/therapeutic use
MH  - Transdermal Patch
MH  - Treatment Outcome
EDAT- 2013/03/20 06:00
MHDA- 2014/03/19 06:00
CRDT- 2013/03/20 06:00
PHST- 2012/11/20 00:00 [received]
PHST- 2013/02/15 00:00 [accepted]
PHST- 2013/03/20 06:00 [entrez]
PHST- 2013/03/20 06:00 [pubmed]
PHST- 2014/03/19 06:00 [medline]
AID - 10.1007/s00702-013-1001-5 [doi]
PST - ppublish
SO  - J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. 
      Epub 2013 Mar 19.