PMID- 22801294
OWN - NLM
STAT- MEDLINE
DCOM- 20130523
LR  - 20221207
IS  - 1537-162X (Electronic)
IS  - 0362-5664 (Linking)
VI  - 35
IP  - 4
DP  - 2012 Jul-Aug
TI  - Efficacy and safety of extended- versus immediate-release pramipexole in Japanese 
      patients with advanced and L-dopa-undertreated Parkinson disease: a double-blind, 
      randomized trial.
PG  - 174-81
LID - 10.1097/WNF.0b013e31825f77b9 [doi]
AB  - OBJECTIVES: To compare the efficacy, safety, tolerability, and trough plasma 
      levels of pramipexole extended-release (ER) and pramipexole immediate-release 
      (IR), and to assess the effects of overnight switching from an IR to an ER 
      formulation, in L-dopa-treated patients with Parkinson disease (PD). METHODS: 
      After a 1- to 4-week screening/enrollment, 112 patients who had exhibited 
      L-dopa-related problems or were receiving suboptimal L-dopa dosage were 
      randomized in double-blind, double-dummy, 1:1 fashion to pramipexole ER once 
      daily or pramipexole IR 2 to 3 times daily for 12 weeks, both titrated to a 
      maximum daily dose of 4.5 mg. Successful completers of double-blind treatment 
      were switched to open-label pramipexole ER, beginning with a 4-week 
      dose-adjustment phase. RESULTS: Among the double-blind treatment patients (n = 56 
      in each group), Unified Parkinson's Disease Rating Scale Parts II+III total 
      scores decreased significantly from baseline and to a similar degree with 
      pramipexole ER and IR formulations. In each group, 47 double-blind patients 
      (83.9%) reported adverse events (AEs), requiring withdrawal of 3 ER patients 
      (5.4%) and 2 IR patients (3.6%). Trough plasma levels at steady state (at the 
      same doses and dose-normalized concentrations) were also similar with both 
      formulations. Among open-label treatment patients (n = 53 from IR to ER), 83% 
      were successfully switched (no worsening of PD symptoms) to pramipexole ER. 
      CONCLUSIONS: In L-dopa-treated patients, pramipexole ER and pramipexole IR 
      demonstrated similar efficacy, safety, tolerability, and trough plasma levels. 
      Patients can be safely switched overnight from pramipexole IR to pramipexole ER 
      with no impact on efficacy.
FAU - Mizuno, Yoshikuni
AU  - Mizuno Y
AD  - Department of Neuroregenerative Medicine, Kitasato University School of Medicine, 
      Kanagawa, Japan. y_mizuno@juntendo.ac.jp
FAU - Yamamoto, Mitsutoshi
AU  - Yamamoto M
FAU - Kuno, Sadako
AU  - Kuno S
FAU - Hasegawa, Kazuko
AU  - Hasegawa K
FAU - Hattori, Nobutaka
AU  - Hattori N
FAU - Kagimura, Tatsuro
AU  - Kagimura T
FAU - Sarashina, Akiko
AU  - Sarashina A
FAU - Rascol, Olivier
AU  - Rascol O
FAU - Schapira, Anthony H V
AU  - Schapira AH
FAU - Barone, Paolo
AU  - Barone P
FAU - Hauser, Robert A
AU  - Hauser RA
FAU - Poewe, Werner
AU  - Poewe W
CN  - Pramipexole ER Study Group
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  - Clin Neuropharmacol
JT  - Clinical neuropharmacology
JID - 7607910
RN  - 0 (Benzothiazoles)
RN  - 0 (Delayed-Action Preparations)
RN  - 46627O600J (Levodopa)
RN  - 83619PEU5T (Pramipexole)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Asian People/ethnology
MH  - Benzothiazoles/*administration & dosage
MH  - Delayed-Action Preparations/administration & dosage
MH  - Disorders of Excessive Somnolence/chemically induced
MH  - Dizziness/chemically induced
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Substitution/methods
MH  - Female
MH  - Humans
MH  - Levodopa/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy/ethnology/*pathology
MH  - Pramipexole
MH  - *Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2012/07/18 06:00
MHDA- 2013/05/25 06:00
CRDT- 2012/07/18 06:00
PHST- 2012/07/18 06:00 [entrez]
PHST- 2012/07/18 06:00 [pubmed]
PHST- 2013/05/25 06:00 [medline]
AID - 10.1097/WNF.0b013e31825f77b9 [doi]
PST - ppublish
SO  - Clin Neuropharmacol. 2012 Jul-Aug;35(4):174-81. doi: 
      10.1097/WNF.0b013e31825f77b9.