Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease.

ABSTRACT:

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 pa

SUBMITTER: Hauser RA 

PROVIDER: S-EPMC4282380 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature