OBJECTIVES: To evaluate incidence of adverse effects (AEs) commonly associated with Parkinson’s disease (PD) and its treatments in a large, real-world population.
METHODS: Retrospective analyses were conducted using the MarketScan database, an employer-based sourced of inpatient, outpatient, and pharmacy claims for >30 million lives (2000–2011). Inclusion criteria were ≥1 PD diagnosis (ICD-9-CM 332.0) and ≥30 days exposure to ≥1 of the following regimens: levodopa monotherapy (L-dopa), dopamine agonist monotherapy (DA), anticholinergic monotherapy (AC), L-dopa+DA, MAOB-inhibitor monotherapy (MAOB), L-dopa+COMT-inhibitor (L-dopa+COMT), L-dopa+AC, L-dopa+MAOB, amantadine monotherapy (AMTD). Patients were followed on AEs (defined by ICD-9-CM diagnoses) over all observed regimen exposures. Analyses were descriptive.
RESULTS: In total, 87,373 patients were identified for inclusion (mean [SD] age 72.8 [10.9] years, 56.8% male). L-dopa was the largest cumulative exposure (80,246 person-years [PYs]), followed by L-dopa+DA (19,871 PYs) and DA (18,324 PYs). Dyskinesia incidence varied by treatment, ranging from 68/1,000 PYs for L-dopa+MAOB to 492/1,000 PYs for AC. Orthostatic hypotension was higher in 5 of the 6 dopamine-containing regimens (64, 47, 45, 31, 25 per 1,000 PYs for L-dopa+COMT, L-dopa+MOAB, L-dopa, L-dopa+DA, and DA, respectively) versus 2 of the 3 non-dopaminergic regimens (18, 19, 32 per 1,000 PYs for AC, MAOB, and AMTD). Edema incidence was highest during DA (215/1,000 PYs) and L-dopa+DA (192/1,000 PYs) exposures. Somnolence was highest, by far, during DA exposure (201 per 1,000 PYs); L-dopa+DA had the next highest somnolence incidence (115 per 1,000 PYs). Incidence of psychoses was high for all regimens (range: 202/1,000 PYs for L-dopa+MAOB to 3,500/1,000 PYs for AC). Abnormal dreaming/sleep attacks and impulse control disorders were not observed in this population, indicating a lack of coding for these conditions in routine practice.
CONCLUSIONS: AE incidence during anti-PD treatment exposure varies by specific regimen. Some AEs, such as orthostatic hypotension, appear to be lower in non-dopaminergic monotherapies.
