PMID- 24834511
OWN - NLM
STAT- MEDLINE
DCOM- 20141124
LR  - 20220331
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Print)
IS  - 1351-5101 (Linking)
VI  - 21
IP  - 5
DP  - 2014 May
TI  - Long-term safety and sustained efficacy of extended-release pramipexole in early 
      and advanced Parkinson's disease.
PG  - 736-43
AB  - BACKGROUND AND PURPOSE: To assess the long-term safety and efficacy of 
      pramipexole as a once-daily (q.d.) extended-release oral formulation in early or 
      advanced Parkinson's disease (PD). METHODS: In two double-blind (DB) studies of 
      early PD and one of advanced PD,active-treatment arms received pramipexole 
      immediate release (IR) or extended release (ER), with exposure lasting up to 33 
      weeks. In open-label (OL) extensions that followed immediately, subjects took ER 
      q.d. for up to 80 weeks, with dosage adjustment permitted (range 0.375-4.5 mg 
      q.d.). RESULTS: Of 590 subjects completing an early-PD DB study, 511 entered the 
      early-PD OL extension; 408 completed it. Reported adverse events (AEs) with 
      incidence >/=10.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain 
      (10.6%). Of 465 subjects completing the advanced-PD DB study, 391 entered the 
      advanced-PD OL extension; 329 completed it. Reported AEs with incidence 
      >/=10.0%were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders 
      were identified by semi-structured interview in 13 subjects (1.4% of 902). In 
      exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale 
      (UPDRS) PartsII + III scores (excluding ex-placebo recipients) remained 
      substantially improved from DB baseline scores prior to pramipexole introduction, 
      at -6.6 and -6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks 
      of pramipexole (33 DB plus 80 OL) in early PD, and -11.5 and -9.1 after up to 113 
      weeks (up to 33 DB plus 80 OL) in advanced PD. CONCLUSIONS: These results support 
      the long-term safety and efficacy of pramipexole ER in early and advanced PD. AEs 
      were typical for dopaminergic medications, and UPDRS scores suggested sustained 
      symptomatic benefit.
FAU - Hauser, R A
AU  - Hauser RA
FAU - Schapira, A H V
AU  - Schapira AH
FAU - Barone, P
AU  - Barone P
FAU - Mizuno, Y
AU  - Mizuno Y
FAU - Rascol, O
AU  - Rascol O
FAU - Busse, M
AU  - Busse M
FAU - Debieuvre, C
AU  - Debieuvre C
FAU - Fraessdorf, M
AU  - Fraessdorf M
FAU - Poewe, W
AU  - Poewe W
CN  - Pramipexole ER Studies Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Benzothiazoles)
RN  - 83619PEU5T (Pramipexole)
SB  - IM
MH  - Aged
MH  - Antiparkinson Agents/*therapeutic use
MH  - Benzothiazoles/*therapeutic use
MH  - Disorders of Excessive Somnolence/etiology
MH  - Disruptive, Impulse Control, and Conduct Disorders/chemically induced
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Delivery Systems/adverse effects/methods
MH  - Dyskinesia, Drug-Induced/etiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Pramipexole
MH  - Severity of Illness Index
MH  - Time Factors
PMC - PMC4282380
EDAT- 2014/05/17 06:00
MHDA- 2014/12/15 06:00
CRDT- 2014/05/17 06:00
PHST- 2014/05/17 06:00 [entrez]
PHST- 2014/05/17 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - 10.1111/ene.12375 [doi]
PST - ppublish
SO  - Eur J Neurol. 2014 May;21(5):736-43. doi: 10.1111/ene.12375.