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Fatigue in levodopa-naïve subjects with Parkinson disease

From the University of Rochester (G.S., D.O.), NY; NeuroHealth (J.H.F.), Brown Medical School, Warwick, RI; University of Maryland School of Medicine (L.S.), Baltimore; Rush University Medical Center (C.L.C.), Chicago, IL; Institute for Neurodegenerative Disorders (K.M.), New Haven, CT; and Columbia University (S.F.), New York, NY.

Address correspondence and reprint requests to Dr. Giovanni Schifitto, Department of Neurology, 1351 Mount Hope Avenue, Suite 223, Rochester, NY 14620 giovanni.schifitto{at}ctcc.rochester.edu.

Background: Fatigue is a common complaint in Parkinson disease (PD). We investigated fatigue in a cohort of previously untreated patients with early PD enrolled in the Earlier vs Later Levodopa (ELLDOPA) clinical trial.

Methods: A total of 361 patients were enrolled in the randomized, double-blind, placebo-controlled ELLDOPA trial and assigned to receive placebo or carbidopa-levodopa 37.5/150 mg, 75/300 mg, or 150/600 mg daily for 40 weeks, followed by a 2-week medication washout period. Subjects who scored >4 on the Fatigue Severity Scale were classified as fatigued. PD severity was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn-Yahr scale, and Schwab-England Activities of Daily Living Scale. A subgroup of subjects underwent [¹²³I]-β-CIT SPECT to measure striatal dopamine transporter density.

Results: Of the 349 ELLDOPA subjects who completed fatigue measures, 128 were classified as fatigued at baseline. The fatigued group was significantly more impaired neurologically (UPDRS, all subscales and Hoehn and Yahr staging) and functionally (Schwab-England Scale) but no significant differences were observed in β-CIT measurements between the two groups. Analysis of covariance showed a greater increase in fatigue score from baseline to the end of the 2-week washout in the placebo group (0.75 points) than in the three groups receiving levodopa (increases of 0.30 [150 mg/day], 0.36 [300 mg/day], and 0.33 [600 mg/day]; p = 0.03 for heterogeneity).

Conclusions: Fatigue is a frequent symptom in early, untreated, non-depressed patients with Parkinson disease (PD), affecting over 1/3 of the patients in this cohort at baseline and 50% by week 42. Fatigue was associated with the severity of PD, and progressed less in patients treated with levodopa.

Abbreviations: ELLDOPA = Earlier vs Later Levodopa; FSS = Fatigue Severity Scale; Ham-D = Hamilton Depression Scale; PD = Parkinson disease; UPDRS = Unified Parkinson's Disease Rating Scale.

Supplemental data at www.neurology.org.

*See the appendix for a list of the Parkinson Study Group ELLDOPA Investigators.

All sources of support for ELLDOPA are identified in reference 9.

Disclosure: The authors report no disclosures.

Received November 12, 2007. Accepted in final form May 1, 2008.

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				Fatigue in Early Parkinson Disease Journal Watch Neurology, October 21, 2008; 2008(1021): 3 - 3. [Full Text]