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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  P arkinson'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 ( AE s) 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  AE s 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 ) Parts II + 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 .  AE s were typical for dopaminergic medications, and  UPDRS  scores suggested sustained symptomatic benefit.

Long‐term safety and sustained efficacy of extended‐release pramipexole in early and advanced P arkinson's disease