Abstract Background As Parkinson's disease (PD) progresses, managing symptoms becomes increasingly difficult. Foslevodopa/foscarbidopa (LDp/CDp), a 24‐hour/day continuous subcutaneous infusion of levodopa/carbidopa (LD/CD) prodrugs, improves motor complications. The feasibility and sustainability of LDp/CDp monotherapy warrants investigation. Objective The aim was to report the efficacy and safety of LDp/CDp monotherapy and combination therapy. Methods This post hoc analysis assessed patients with PD and ≥2.5 “Off” hours/day receiving LDp/CDp monotherapy or combination therapy in 3 trials: a 12‐week randomized active‐controlled trial (RCT) comparing LDp/CDp with oral immediate‐release LD/CD (NCT04380142), a 52‐week open‐label trial of LDp/CDp (NCT03781167), and its 96‐week open‐label extension study (OLE; NCT04379050). Monotherapy was defined as receiving LDp/CDp without concomitant PD medications; combination therapy was defined as receiving LDp/CDp with other PD medications. Results In the RCT, 74 of 141 patients received LDp/CDp. The 52‐week trial enrolled 244 patients; 129 entered the OLE. Of LDp/CDp‐treated patients, 19 of 74 (25.7%) in the RCT, 49 of 244 (20.1%) in the 52‐week trial, and 46 of 129 (35.7%) in the OLE received monotherapy. In the RCT, mean (standard deviation) change from baseline to week 12 in “Off” time was −4.5 (4.4) and −3.0 (3.5) hours for monotherapy and combination therapy, respectively; +4.1 (3.7) and +3.1 (3.6) hours for “On” time without troublesome dyskinesia; and +4.0 (3.6) and +4.0 (3.9) hours for “On” time without dyskinesia. Efficacy was similar in open‐label trials. Improvements in the Movement Disorder Society‐Unified Parkinson's Disease Rating Scale Part II, 39‐item Parkinson's Disease Questionnaire, Parkinson's Disease Sleep Scale‐2 scores, and overall safety were comparable between monotherapy and combination therapy groups. Conclusions LDp/CDp monotherapy treatment may be suitable for up to 96 weeks.
Aldred et al. (Wed,) studied this question.