Abstract | OBJECTIVES: To compare the efficacy, safety, tolerability, and trough plasma levels of pramipexole extended-release (ER) and pramipexole immediate-release (IR), and to assess the effects of overnight switching from an IR to an ER formulation, in L-dopa-treated patients with Parkinson disease (PD). METHODS: After a 1- to 4-week screening/enrollment, 112 patients who had exhibited L-dopa-related problems or were receiving suboptimal L-dopa dosage were randomized in double-blind, double-dummy, 1:1 fashion to pramipexole ER once daily or pramipexole IR 2 to 3 times daily for 12 weeks, both titrated to a maximum daily dose of 4.5 mg. Successful completers of double-blind treatment were switched to open-label pramipexole ER, beginning with a 4-week dose-adjustment phase. RESULTS: Among the double-blind treatment patients (n = 56 in each group), Unified Parkinson's Disease Rating Scale Parts II+III total scores decreased significantly from baseline and to a similar degree with pramipexole ER and IR formulations. In each group, 47 double-blind patients (83.9%) reported adverse events (AEs), requiring withdrawal of 3 ER patients (5.4%) and 2 IR patients (3.6%). Trough plasma levels at steady state (at the same doses and dose-normalized concentrations) were also similar with both formulations. Among open-label treatment patients (n = 53 from IR to ER), 83% were successfully switched (no worsening of PD symptoms) to pramipexole ER. CONCLUSIONS:
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Authors | Yoshikuni Mizuno, Mitsutoshi Yamamoto, Sadako Kuno, Kazuko Hasegawa, Nobutaka Hattori, Tatsuro Kagimura, Akiko Sarashina, Olivier Rascol, Anthony H V Schapira, Paolo Barone, Robert A Hauser, Werner Poewe, Pramipexole ER Study Group |
Journal | Clinical neuropharmacology
(Clin Neuropharmacol)
2012 Jul-Aug
Vol. 35
Issue 4
Pg. 174-81
ISSN: 1537-162X [Electronic] United States |
PMID | 22801294
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzothiazoles
- Delayed-Action Preparations
- Levodopa
- Pramipexole
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Topics |
- Aged
- Aged, 80 and over
- Asian People
(ethnology)
- Benzothiazoles
(administration & dosage)
- Delayed-Action Preparations
(administration & dosage)
- Disorders of Excessive Somnolence
(chemically induced)
- Dizziness
(chemically induced)
- Double-Blind Method
- Drug Administration Schedule
- Drug Substitution
(methods)
- Female
- Humans
- Levodopa
(administration & dosage)
- Male
- Middle Aged
- Parkinson Disease
(drug therapy, ethnology, pathology)
- Pramipexole
- Severity of Illness Index
- Treatment Outcome
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