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Risk factors for somnolence, edema, and hallucinations in early Parkinson disease

From the University of Rochester (K.M.B., R.G.H., M.P.M.) and University of Rochester Medical Center (I.H.R.), NY.

Address correspondence and reprint requests to Dr. Kevin M. Biglan, University of Rochester School of Medicine and Dentistry, Department of Neurology, 1351 Mt. Hope Avenue, Suite 223, Rochester, NY 14620 kevin.biglan{at}ctcc.rochester.edu

Background: The CALM-PD trial evaluated the development of motor complications in subjects with early Parkinson disease (PD) randomized to initial treatment with either pramipexole or levodopa. A secondary finding of the trial was a higher than anticipated development or worsening of somnolence and edema and development of hallucinations.

Objectives: To investigate risk factors for somnolence, edema, and hallucinations in patients with early PD initiating dopaminergic therapy.

Methods: This was a secondary analysis of data from the CALM-PD trial. Baseline patient characteristics were evaluated for their associations with the development or worsening of somnolence and edema and the development of hallucinations using Cox proportional hazards regression models.

Results: Kaplan-Meier estimates of the 4-year incidence of the development or worsening of somnolence and edema and the development of hallucinations were 35%, 45%, and 17%. Initial pramipexole treatment (hazard ratio [HR] 2.22, 95% CI 1.41, 3.50, p < 0.001), male gender (HR 1.79, 95% CI 1.09, 2.93, p = 0.02), and >5 systems with a comorbid illness (HR 1.62, 95% CI 1.04, 2.51, p = 0.03) were associated with somnolence. Initial pramipexole treatment (HR 3.18, 95% CI 1.95, 5.18, p < 0.0001), female gender (HR 1.46, 95% CI 0.94, 2.27, p = 0.09), and comorbid cardiac disease (HR 1.59, 95% CI 1.02, 2.47, p = 0.04) were associated with edema. Age 65 (HR 2.06, 95% CI 0.98, 4.32, p = 0.06), Mini-Mental State Examination score >28 (HR 0.42, 95% CI 0.19, 0.91, p = 0.03), and >5 systems with a comorbid illness (HR 3.42, 95% CI 1.59, 7.38, p = 0.002) were associated with hallucinations.

Conclusions: Comorbid illnesses are important and overlooked risk factors for the development of somnolence, edema, and hallucinations. When initiating therapy with pramipexole, patients should be counseled about and monitored for somnolence and edema. Slight decrements in cognitive function and older age are associated with an increased risk of hallucinations.

*See reference 6 for a full listing of the CALM-PD investigators.

Disclosure: The CALM-PD clinical trial was sponsored by Boehringer Ingelheim. The secondary analysis described in this article was not supported by industry. The authors have nothing to disclose.

Received August 11, 2006. Accepted in final form February 16, 2007.

This article has been cited by other articles:

				Parkinson Study Group CALM Cohort Investigators Long-term Effect of Initiating Pramipexole vs Levodopa in Early Parkinson Disease Arch Neurol, May 1, 2009; 66(5): 563 - 570. [Abstract] [Full Text] [PDF]

				Somnolence, Edema, and Hallucinations in Parkinson Disease Journal Watch Neurology, October 16, 2007; 2007(1016): 1 - 1. [Full Text]