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Long-term Effect of Initiating Pramipexole vs Levodopa in Early Parkinson Disease
Parkinson Study Group CALM Cohort Investigators
Arch Neurol. 2009;66(5):563-570. Published online March 9, 2009 (doi:10.1001/archneurol.2009.32).
Objective To compare the long-term outcomes of subjects initially treated with pramipexole dihydrochloride with those of subjects initially treated with levodopa in the Comparison of the Agonist Pramipexole With Levodopa on Motor Complications of Parkinson's Disease (CALM-PD) trial.
Design Up to 2 years of open extended follow-up of the CALM-PD subjects.
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 were enrolled between October 1996 and August 1997, a subset of whom consented to extended follow-up until August 2003 (n = 222).
Intervention Subjects were randomized to receive initial treatment with either pramipexole (n = 151) or levodopa (n = 150). Investigators were permitted to add open-label levodopa or other antiparkinsonian medications to treat ongoing or emerging disability.
Main Outcome Measures The primary outcome variable was the time-weighted average of self-reported disability scores in the "on" and "off" states as measured by the Schwab and England Activities of Daily Living Scale at the final visit. Secondary outcomes included the Unified Parkinson's Disease Rating Scale score, the presence and severity of dopaminergic motor complications, quality-of-life scale scores, Geriatric Depression Scale score, Epworth Sleepiness Scale score, and adverse events.
Results After a mean (SD) follow-up of 6.0 (0.2) years, mean (SD) self-reported weighted Schwab and England Activities of Daily Living Scale scores were similar in the initial pramipexole (79.9 [16.2]) and initial levodopa (82.5 [14.6]) groups (P = .19). Dopaminergic motor complications (wearing off, on-off effects, or dyskinesias) were more common in the initial levodopa group (68.4%) than in the initial pramipexole group (50.0%) (P = .002), although disabling dyskinesias were uncommon in both groups. The mean (SD) Epworth Sleepiness Scale score was significantly higher in the initial pramipexole group (11.3 [5.8]) than in the initial levodopa group (8.6 [4.7]) (P < .001). Mean (SD) changes from baseline in the total Unified Parkinson's Disease Rating Scale score did not significantly differ between the initial pramipexole (2.4 [17.4]) and initial levodopa (0.5 [17.1]) groups (P = .11).
Conclusions The policies of initial pramipexole and initial levodopa use followed by open-label levodopa use resulted in similar self-reported disability 6 years after randomization. Persistent differences favoring initial pramipexole were seen in the rates of dopaminergic motor complications, with less severe somnolence favoring initial levodopa.
Trial Registration clinicaltrials.gov Identifier: NCT00804479
Author Affiliations: The Parkinson Study Group CALM Cohort Investigators and their affiliations are listed here.
Steering Committee: Robert Holloway, MD, principal investigator, University of Rochester, Rochester, New York; Kenneth Marek, MD, co–principal investigator, Institute for Neurodegenerative Disorders, New Haven, Connecticut; Kevin Biglan, MD, MPH, University of Rochester; Andrew Dick, PhD, University of Rochester; Stanley Fahn, MD, Columbia University, New York, New York; Elaine Julian-Baros, CCRC, ex officio, University of Rochester; Cornelia Kamp, MBA, ex officio, University of Rochester; Karl Kieburtz, MD, University of Rochester; Anthony Lang, MD, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada; Michael McDermott, PhD, University of Rochester; John Seibyl, MD, Institute for Neurodegenerative Disorders; Aileen Shinaman, JD, ex officio, University of Rochester; Ira Shoulson, MD, University of Rochester; William Weiner, MD, University of Maryland School of Medicine, Baltimore.
CALM Cohort Participating Investigators and Coordinators: Rajesh Pahwa, MD, University of Kansas Medical Center, Kansas City; David A. Grimes, MD, Ottawa Hospital Civic Site, Ottawa, Ontario, Canada; Janis Miyasaki, MD, Lisa Johnston, RN, BSCN, CNN, Toronto Western Hospital, University Health Network; Michel Panisset, MD, McGill Centre for Studies in Aging, Verdun, Quebec, Canada; Stewart A. Factor, DO, Sharon Evans, LPN, Albany Medical College, Albany, New York; Holly Shill, MD, Mary Harrigan, RN, MN, Barrow Neurological Institute, Phoenix, Arizona; John P. Hammerstad, MD, Oregon Health and Science University, Portland; Ali H. Rajput, MD, Saskatoon District Health Board, Royal University Hospital, Saskatoon, Saskatchewan, Canada; Danna Jennings, MD, Institute for Neurodegenerative Disorders; David Song, MD, Deborah Fontaine, RNCS, MS, University of California, San Diego; Peter A. LeWitt, MD, Clinical Neuroscience Center, Southfield, Michigan; G. Frederick Wooten, MD, Elke Rost-Ruffner, RN, BSN, University of Virginia, Charlottesville; Ronald F. Pfeiffer, MD, University of Tennessee, Memphis; David Standaert, MD, PhD, Harvard Medical School, Boston, Massachusetts; Marsha Tennis, RN, Massachusetts General Hospital, Charlestown; Oksana Suchowersky, MD, Carol Pantella, RN, University of Calgary, Calgary, Alberta, Canada; Robert L. Rodnitzky, MD, Judith Dobson, RN, University of Iowa, Iowa City; Roger Kurlan, MD, Debra Berry, MSN, NP, University of Rochester; Sandra Kostyk, MD, PhD, Ohio State University, Columbus; David E. Riley, MD, Joseph Jankovic, MD, Farah Atassi, MD, MPH, Christine Hunter, RN, CCRC, Baylor College of Medicine, Houston, Texas; Cheryl Waters, MD, Columbia University Medical Center, New York, New York. Dr Standaert is now with the University of Alabama at Birmingham.
CALM Cohort Clinical Trials Coordination Center and Biostatistics Center: Susan Bennett, AAS, Alicia Brocht, BA, Susan Daigneault, Megan Romer, MS, Elaine Julian-Baros, CCRC, Cornelia Kamp, MBA, Earl Westerlund, BS, Arthur Watts, BS, University of Rochester.
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