BACKGROUND: To characterize OFF and ON times in a real-world sample of patients with Parkinson’s disease (PD) experiencing motor fluctuations (MF) with carbidopa/levodopa (CD/LD) and other adjunctive PD treatments.
OBJECTIVES: Levodopa remains the most effective treatment for PD, but the benefit tends to decrease as disease progresses. MFs often develop over time, with patients experiencing longer OFF periods, ON periods with dyskinesia, and shorter “good” ON periods (ON periods without troublesome dyskinesia).
METHODS: Neurologists treating PD patients in the United States were invited to participate in this retrospective medical chart review study, which included adult patients (≥18 years) who began experiencing MFMFs between 01/2014 and 04/2019 while taking CD/LD. Data were abstracted from patients’ medical records (electronic or hard copy) and recorded on a case report form (CRF). Outcomes, as recorded at the most recent office visit, included: waking hours in OFF state; time of the day with most bothersome OFF period; and waking hours in ON state with troublesome dyskinesia. These outcomes were analyzed descriptively, stratified by duration of MFs (<2 years [MF<2] or ≥2 years [MF≥2]).
METHODS: Based on CRF data (N=310), 189 (61%) patients were male and 287 (93%) were white. Median age (interquartile [IQR] range) at PD onset was 64.8 (58.0-71.3) years; median age at MF onset was 69.1 (63.3-75.6) years. 193 (62%) patients had MF<2 and 117 (38%) had MF≥2 at their most recent visit. Median time (IQR range) in OFF state was 3.0 (2.0-5.0) hours in MF≥2 as well as MF<2. Mean percentage ( standard deviation [SD]) of waking hours in OFF state was 25.8% (17.2%) and 23.7% (16.6%) in MF≥2 and MF<2 patients, respectively. More than 50% of MF≥2 and MF<2 patients experienced the most bothersome OFF period in the morning, either before the first CD/LD or after the first ON period. Median time (IQR range) in ON state with troublesome dyskinesia was 0.5 (0.0-2.0) hours in MF≥2 patients and 0.0 (0.0-1.0) hours in MF<2 patients; mean percentage (SD) was 8.1% (12.3%) and 6.4% (11.2%) in MF≥2 and MF<2 patients, respectively.
CONCLUSIONS: Patients with a longer history of MF may experience more time in OFF state and lesser time in “good” ON, despite being treated with CD/LD and other adjunctive medications. More research is needed to understand whether early treatment of MF impacts long-term outcomes in patients with PD.
