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 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.

• Authors: R A Hauser, A H V Schapira, P Barone, Y Mizuno, O Rascol, M Busse, C Debieuvre, M Fraessdorf, W Poewe, Pramipexole ER Studies Group
• Journal: European journal of neurology (Eur J Neurol) Vol. 21 Issue 5 Pg. 736-43 (May 2014) ISSN: 1468-1331 [Electronic] England
• PMID: 24834511 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiparkinson Agents
• Benzothiazoles
• Pramipexole

Topics

• Aged
• Antiparkinson Agents (therapeutic use)
• Benzothiazoles (therapeutic use)
• Disorders of Excessive Somnolence (etiology)
• Disruptive, Impulse Control, and Conduct Disorders (chemically induced)
• Double-Blind Method
• Drug Administration Schedule
• Drug Delivery Systems (adverse effects, methods)
• Dyskinesia, Drug-Induced (etiology)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Parkinson Disease (drug therapy)
• Pramipexole
• Severity of Illness Index
• Time Factors