PMID- 21354368
OWN - NLM
STAT- MEDLINE
DCOM- 20110729
LR  - 20181201
IS  - 1878-5506 (Electronic)
IS  - 1389-9457 (Linking)
VI  - 12
IP  - 4
DP  - 2011 Apr
TI  - Efficacy and augmentation during 6 months of double-blind pramipexole for 
      restless legs syndrome.
PG  - 351-60
LID - 10.1016/j.sleep.2010.12.007 [doi]
AB  - BACKGROUND: Pramipexole is an effective treatment for restless legs syndrome 
      (RLS), but no controlled studies have lasted >12 weeks. METHODS: RLS patients 
      (N=331) with pretreatment serum ferritin >30 ng/mL were randomly assigned to take 
      double-blind optimized pramipexole (0.125-0.75 mg/d) or placebo for 26 weeks. The 
      primary efficacy endpoint was change in International RLS Study Group Rating 
      Scale (IRLS) score. Other endpoints assessed global change, symptoms, and QoL. 
      Patients maintained symptom diaries. Cases meeting predefined criteria for 
      suspected augmentation were reviewed by a blinded expert panel, which used a 
      predefined algorithm. RESULTS: Among 321 patients providing post-baseline data, 
      of whom 234 completed 26 weeks, pramipexole was more effective than placebo by 
      multiple endpoints, including an adjusted mean IRLS score change of -13.7 vs. 
      -11.1 (p=0.0077) and an IRLS responder rate (>/=50% score reduction) of 58.6% vs. 
      42.8% (p=0.0044). Efficacy showed considerable country-to-country variability. 
      Six-month incidence of confirmed augmentation was 9.2% for pramipexole and 6.0% 
      for placebo. The rate increased with treatment duration for pramipexole but not 
      placebo. Treatment-related adverse events (AEs) were more likely for pramipexole 
      than for placebo, but discontinuation due to AEs was less likely. CONCLUSIONS: 
      During a 6-month period, pramipexole was effective, safe, and generally well 
      tolerated. Because risk of augmentation may have increased over 6 months, it 
      should be studied in longer trials. Beginning or mild augmentation is difficult 
      to distinguish from natural RLS fluctuation, at least in a non-iron-deficient 
      population.
CI  - Copyright (c) 2011 Elsevier B.V. All rights reserved.
FAU - Hogl, Birgit
AU  - Hogl B
AD  - Department of Neurology, Innsbruck Medical University, Anichstrasse 35, A-6020 
      Innsbruck, Austria. birgit.ho@i-med.ac.at
FAU - Garcia-Borreguero, Diego
AU  - Garcia-Borreguero D
FAU - Trenkwalder, Claudia
AU  - Trenkwalder C
FAU - Ferini-Strambi, Luigi
AU  - Ferini-Strambi L
FAU - Hening, Wayne
AU  - Hening W
FAU - Poewe, Werner
AU  - Poewe W
FAU - Brenner, Stefanie S
AU  - Brenner SS
FAU - Fraessdorf, Mandy
AU  - Fraessdorf M
FAU - Busse, Michael
AU  - Busse M
FAU - Albrecht, Stefan
AU  - Albrecht S
FAU - Allen, Richard P
AU  - Allen RP
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110226
PL  - Netherlands
TA  - Sleep Med
JT  - Sleep medicine
JID - 100898759
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Benzothiazoles)
RN  - 83619PEU5T (Pramipexole)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiparkinson Agents/*administration & dosage/adverse effects
MH  - Benzothiazoles/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pramipexole
MH  - *Quality of Life
MH  - Restless Legs Syndrome/*drug therapy
MH  - Substance Withdrawal Syndrome
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/03/01 06:00
MHDA- 2011/07/30 06:00
CRDT- 2011/03/01 06:00
PHST- 2010/06/11 00:00 [received]
PHST- 2010/12/07 00:00 [revised]
PHST- 2010/12/10 00:00 [accepted]
PHST- 2011/03/01 06:00 [entrez]
PHST- 2011/03/01 06:00 [pubmed]
PHST- 2011/07/30 06:00 [medline]
AID - S1389-9457(11)00002-5 [pii]
AID - 10.1016/j.sleep.2010.12.007 [doi]
PST - ppublish
SO  - Sleep Med. 2011 Apr;12(4):351-60. doi: 10.1016/j.sleep.2010.12.007. Epub 2011 Feb 
      26.