Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial.
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Holloway Robert G, Shoulson Ira, Fahn Stanley, Kieburtz Karl, Lang Anthony, Marek Kenneth, McDermott Michael, Seibyl John, Weiner William, Musch Bruno, Kamp Cornelia, Welsh Mickie, Shinaman Aileen, Pahwa Rajesh, Barclay Lynn, Hubble Jean, LeWitt Peter, Miyasaki Janis, Suchowersky Oksana, Stacy Mark, Russell David S, Ford Blair, Hammerstad John, Riley David, Standaert David, Wooten Frederick, Factor Stewart, Jankovic Joseph, Atassi Farah, Kurlan Roger, Panisset Michel, Rajput Ali, Rodnitzky Robert, Shults Cliff, Petsinger Giselle, Waters Cheryl, Pfeiffer Ronald, Biglan Kevin, Borchert Leona, Montgomery Amy, Sutherland Laura, Weeks Carolyn, DeAngelis Maryan, Sime Elspeth, Wood Susan, Pantella Carol, Harrigan Mary, Fussell Barbara, Dillon Sandra, Alexander-Brown Barbara, Rainey Pamela, Tennis Marsha, Rost-Ruffner Elke, Brown Diane, Evans Sharon, Berry Debra, Hall Jean, Shirley Theresa, Dobson Judith, Fontaine Deborah, Pfeiffer Brenda, Brocht Alicia, Bennett Susan, Daigneault Susan, Hodgeman Karen, O'Connell Carolynn, Ross Tori, Richard Karen, Watts Arthur, Parkinson Study Group
Аннотация
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.