Comparative Effectiveness of Carbidopa–Levodopa Enteral Suspension and Deep Brain Stimulation on Parkinson’s Disease-Related Pill Burden Reduction in Advanced Parkinson’s Disease: A Retrospective Real-World Cohort Study

Abstract

Introduction In advanced Parkinson’s disease (PD), a high pill burden is associated with poor compliance, reduced control of symptoms, and decreased quality of life. We assessed the impact of carbidopa–levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on PD-related pill burden. Methods A retrospective cohort analysis was conducted in the IBM MarketScan and Medicare Supplemental databases. Patients with advanced PD, taking only PD medications, and initiating CLES or DBS between 9 January 2015 and 31 July 2019 were identified. CLES patients were matched to DBS patients in a 1:3 ratio based on a propensity score to balance patient characteristics. Pill burden was measured as a 30-day average number of PD-related pills per day and was captured monthly. Pill-free status was evaluated as the percentage of patients receiving CLES or DBS monotherapy. Descriptive statistics were used to compare pill counts and assess the proportion of patients on monotherapy at 6 and 12 months after initiating CLES or DBS. Results The cohorts included 34 CLES patients matched to 97 DBS patients. A significant reduction in PD-related pill burden was observed at 6 months after initiation of CLES or DBS (∆CLES: −5.62, p < 0.0001; ∆DBS: −1.48, p = 0.0022). PD-related pill burden reduction in CLES patients was significantly greater than in matched DBS patients at 6 months (∆: −4.14, p < 0.0001), which was sustained at 12 months after initiation. At 12 months, nearly three times more CLES patients were pill free than DBS patients (29.41% and 10.31%, respectively, p = 0.0123). Conclusions Device-aided therapies such as CLES and DBS are effective in significantly reducing PD-related pill burden. Patients treated with CLES were more likely to achieve pill-free status than patients receiving DBS.

Impact of Infusion Therapies on Quality of Life in Advanced Parkinson’s Disease

“…A retrospective cohort analysis has compared LCIG infusion (34 patients) with DBS (97 patients). 26 After 12 months of treatment, a significantly greater reduction in daily pill burden (p ≤ 0.0001), with more patients being able to discontinue oral medication completely, was observed in the LCIG infusion-treated group. Currently, LCIG and DBS are also being compared in the INfusion VErsus STimulation in Parkinson’s Disease (INVEST; NCT02480803) study in patients with PD.…”

“…In advanced PD, a high pill burden is often associated with poor compliance, a progressively worsening control of motor and non-motor symptoms, and deterioration of QoL. 26 Indeed, studies have shown that up to 67% of Parkinson’s patients take <80% of their prescribed PD medications. 27 As PD progresses, further medication adjustments become necessary in order to adequately manage symptoms.…”

Effects of Levodopa-Carbidopa Intestinal Gel on Dyskinesia and Non-Motor Symptoms Including Sleep: Results from a Meta-Analysis with 24-Month Follow-Up

“…The link between sleep dysfunction and dopamine pathophysiology can also be supported by reduced binding of 11 C-raclopride in the hypothalamus among PD patients, which is a key sleep and autonomic regulatory center [ 38 ]. Switching to LCIG would allow reduction in other anti-parkinsonian medications and potentially achieving monotherapy during the day [ 39 ]. As result, reduction in other dopaminergic medications may lead to improvements in other non-motor symptoms such as insomnia, sedation and urinary urgency [ 25 ].…”

Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson’s Disease

“…There are limited real-world studies directly assessing and comparing the impact of CLES versus DBS on oral PD-related pill burden and resultant LEDD. A prior study of commercial and supplemental Medicare insured patients showed benefit of these device-aided therapies to reduce oral pill burden [ 22 ]. We extend these findings to include assessment of LEDD and focus this work on the 100% Medicare fee-for-service (FFS) population, as PD predominately affects older adults.…”