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: 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 > or =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: