PMID- 16755554
OWN - NLM
STAT- MEDLINE
DCOM- 20070202
LR  - 20181201
IS  - 0885-3185 (Print)
IS  - 0885-3185 (Linking)
VI  - 21
IP  - 9
DP  - 2006 Sep
TI  - Controlled withdrawal of pramipexole after 6 months of open-label treatment in 
      patients with restless legs syndrome.
PG  - 1404-10
AB  - Although dopamine agonists are becoming first-line therapy for restless legs 
      syndrome (RLS), few reports describe treatment periods exceeding 12 weeks. Here, 
      150 RLS patients who had responded to pramipexole during a 6-month run-in period 
      (mean dose, 0.50 mg) were randomly assigned to receive placebo or continue 
      receiving pramipexole at an individually optimized dose of 0.125 to 0.75 mg/day 
      for a further 3 months. Patients switched to placebo reached the primary endpoint 
      (a predefined worsening on both the Clinical Global Impressions-Global 
      Improvement scale and the International RLS Study Group Rating Scale) 
      significantly more often than patients who continued to receive pramipexole 
      (85.5% vs. 20.5%; P < 0.0001). They also reached the primary endpoint faster, in 
      5 versus 42 days to a Kaplan-Meier survival estimate of 0.85 and 7 versus > 84 
      days to an estimate of 0.5. Over the total 9 months, clinician and patient 
      ratings of symptoms, sleep, and quality of life identified no decline in 
      pramipexole's benefit or tolerability. The great majority of adverse events (AEs) 
      were mild or moderate, and of expected types. Augmentation was considered an AE, 
      but in this population of responders it did not occur.
CI  - (c) 2006 Movement Disorder Society.
FAU - Trenkwalder, Claudia
AU  - Trenkwalder C
AD  - Paracelsus-Elena Klinik, Kassel, Germany. ctrenkwalder@gmx.de
FAU - Stiasny-Kolster, Karin
AU  - Stiasny-Kolster K
FAU - Kupsch, Andreas
AU  - Kupsch A
FAU - Oertel, Wolfgang H
AU  - Oertel WH
FAU - Koester, Juergen
AU  - Koester J
FAU - Reess, Juergen
AU  - Reess J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Mov Disord
JT  - Movement disorders : official journal of the Movement Disorder Society
JID - 8610688
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Benzothiazoles)
RN  - 0 (Dopamine Agonists)
RN  - 83619PEU5T (Pramipexole)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiparkinson Agents/*administration & dosage/*adverse effects
MH  - Benzothiazoles/*administration & dosage/*adverse effects
MH  - Dopamine Agonists/*administration & dosage/*adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Pramipexole
MH  - Quality of Life
MH  - Recurrence
MH  - Restless Legs Syndrome/*drug therapy
MH  - Sleep/drug effects
MH  - Substance Withdrawal Syndrome/*etiology
EDAT- 2006/06/07 09:00
MHDA- 2007/02/03 09:00
CRDT- 2006/06/07 09:00
PHST- 2006/06/07 09:00 [pubmed]
PHST- 2007/02/03 09:00 [medline]
PHST- 2006/06/07 09:00 [entrez]
AID - 10.1002/mds.20983 [doi]
PST - ppublish
SO  - Mov Disord. 2006 Sep;21(9):1404-10. doi: 10.1002/mds.20983.