Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease.
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| Title: | Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease. |
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| Authors: | Hauser, R. A., Schapira, A. H. V., Barone, P., Mizuno, Y., Rascol, O., Busse, M., Debieuvre, C., Fraessdorf, M., Poewe, W. |
| Source: | European Journal of Neurology. May2014, Vol. 21 Issue 5, p736-743. 8p. |
| Subjects: | Pramipexole, Drowsiness, Edema, Backache, Dyskinesias |
| 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) 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. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| 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) 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. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit. [ABSTRACT FROM AUTHOR] |
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| ISSN: | 13515101 |
| DOI: | 10.1111/ene.12375 |
