Information de reference pour ce titreAccession Number: | 00000816-200407000-00009.
|
Author: | The Parkinson Study Group *
|
Institution: | (*)The Writing Group members for the Parkinson Study Group who had complete access to the raw data needed for this report and who bear authorship responsibility for this report are given in the "Author Contributions" at the end of this article. A complete list of the affiliations for the Writing Group appears along with a complete list of the members of the Parkinson Study Group at the end of this article.
|
Title: | |
Source: | Archives of Neurology. 61(7):1044-1053, July 2004.
|
Abstract: | Background: The best way to initiate dopaminergic therapy for early Parkinson disease remains unclear.
Objective: To compare initial treatment with pramipexole vs levodopa in early Parkinson disease, followed by levodopa supplementation, with respect to the development of dopaminergic motor complications, other adverse events, and functional and quality-of-life outcomes.
Design: Multicenter, parallel-group, double-blind, randomized controlled trial.
Setting: Academic movement disorders clinics at 22 sites in the United States and Canada.
Patients: Patients with early Parkinson disease (N = 301) who required dopaminergic therapy to treat emerging disability, enrolled between October 1996 and August 1997 and observed until August 2001.
Intervention: Subjects were randomly assigned to receive 0.5 mg of pramipexole 3 times per day with levodopa placebo (n = 151) or 25/100 mg of carbidopa/levodopa 3 times per day with pramipexole placebo (n = 150). Dosage was escalated during the first 10 weeks for patients with ongoing disability. Thereafter, investigators were permitted to add open-label levodopa or other antiparkinsonian medications to treat ongoing or emerging disability.
Main Outcome Measures: Time to the first occurrence of dopaminergic complications: wearing off, dyskinesias, on-off fluctuations, and freezing; changes in the Unified Parkinson's Disease Rating Scale and quality-of-life scales; and adverse events.
Results: Initial pramipexole treatment resulted in a significant reduction in the risk of developing dyskinesias (24.5% vs 54%; hazard ratio, 0.37; 95% confidence interval [CI], 0.25-0.56; P<.001) and wearing off (47% vs 62.7%; hazard ratio, 0.68; 95% CI, 0.49-0.63; P = .02). Initial levodopa treatment resulted in a significant reduction in the risk of freezing (25.3% vs 37.1%; hazard ratio, 1.7; 95% CI, 1.11-2.59; P = .01). By 48 months, the occurrence of disabling dyskinesias was uncommon and did not significantly differ between the 2 groups. The mean improvement in the total Unified Parkinson's Disease Rating Scale score from baseline to 48 months was greater in the levodopa group than in the pramipexole group (2 +/- 15.4 points vs -3.2 +/- 17.3 points, P = .003). Somnolence (36% vs 21%, P = .005) and edema (42% vs 15%, P<.001) were more common in pramipexole-treated subjects than in levodopa-treated subjects. Mean changes in quality-of-life scores did not differ between the groups.
Conclusions: Initial treatment with pramipexole resulted in lower incidences of dyskinesias and wearing off compared with initial treatment with levodopa. Initial treatment with levodopa resulted in lower incidences of freezing, somnolence, and edema and provided for better symptomatic control, as measured by the Unified Parkinson's Disease Rating Scale, compared with initial treatment with pramipexole. Both options resulted in similar quality of life. Levodopa and pramipexole both appear to be reasonable options as initial dopaminergic therapy for Parkinson disease, but they are associated with different efficacy and adverse-effect profiles.
Copyright 2004 by the American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use. American Medical Association, 515 N. State St, Chicago, IL 60610.
|
Author Keywords: | Levodopa; Parkinson Disease; Pramipexole; Randomized Trials.
|
References: | 1. Piercey MF, Camacho-Ochoa M, Smith MW. Functional roles for dopamine-receptor subtypes. Clin Neuropharmacol. 1995;18(suppl):S34-S42.
2. Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: a randomized controlled trial. JAMA. 2000;284:1931-1938.
3. Parkinson Study Group. A randomized controlled trial comparing pramipexole with levodopa in early Parkinson's disease: design and methods of the CALM-PD Study. Clin Neuropharmacol. 2000;23:34-44.
4. Marek KL, The Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA. 2002;287:1653-1661.
5. Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967;17:427-442.
6. Parkinson Study Group. DATATOP: a multicenter controlled clinical trial in early Parkinson's disease. Arch Neurol. 1989;46:1052-1060.
7. Lang AE, Fahn S. Assessment of Parkinson's disease. In: Munsat TL, ed. Quantification of Neurologic Deficit. Boston, Mass: Butterworth-Heinemann; 1989:285-309.
8. Welsh M, McDermott MP, Holloway RG, et al. Development and testing of the Parkinson's Disease Quality of Life Scale: the PDQUALIF. Mov Disord. 2003;18:637-645.
9. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy. 1990;12:199-208.
10. Richards M, Marder K, Cote L, Mayeux R. Interrater reliability of the Unified Parkinson's Disease Rating Scale motor examination. Mov Disord. 1994;9:89-91.
11. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med. 1991;10:1595-1605.
12. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York, NY: John Wiley & Sons; 1980.
13. Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics. 1996;52:1324-1333.
14. Rascol O, Brooks DJ, Korczyn AD, De Deyn P, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000;342:1484-1491.
15. Hobson DE, Lang AE, Martin WR, Razmy A, Rivest J, Fleming J. Excessive daytime sleepiness and sudden-onset sleep in Parkinson disease: a survey by the Canadian Movement Disorders Group. JAMA. 2002;287:455-463.
16. Tan EK, Ondo W. Clinical characteristics of pramipexole-induced peripheral edema. Arch Neurol. 2000;57:729-732.
17. Medical Economics Company. Drug Topics Red Book. Montvale, NJ: Medical Economics Co; 2001.
|
Language: | English.
|
Document Type: | Original Contribution.
|
Journal Subset: | Clinical Medicine. Behavioral & Social Sciences.
|
ISSN: | 0003-9942
|
NLM Journal Code: | 80k, 0372436
|
Annotation(s) | |