Unknown

Dataset Information

0

Long-term results of carbidopa/levodopa enteral suspension across the day in advanced Parkinson's disease: Post-hoc analyses from a large 54-week trial.


ABSTRACT:

Introduction

Carbidopa/levodopa enteral suspension (CLES) previously demonstrated reduction in total daily OFF from baseline by over 4 hours in advanced Parkinson's disease patients across 54 weeks. Evidence on CLES's long-term effectiveness on patterns of motor-symptom control throughout the day remains limited.

Methods

We present post-hoc analyses of a large, open-label study of CLES monotherapy (N = 289). Diary data recorded patients' motor states at 30-minute intervals over 3 days at baseline and weeks 4, 12, 24, 36, and 54. Adjusted generalized linear mixed models assessed changes from baseline at each timepoint for four outcome measures: time to ON without troublesome dyskinesia (ON-woTD) after waking, motor-symptom control as measured by motor states' durations throughout the day, number of motor-state transitions, and presence of extreme fluctuations (OFF to ON with TD).

Results

Patients demonstrated short-term (wk4) and sustained (wk54) improvement in all outcomes compared to baseline. At weeks 4 and 54, patients were more likely to reach ON-woTD over the course of their day (HR: 1.86 and 2.51, both P < 0.0001). Across 4-hour intervals throughout the day, patients also experienced increases in ON-woTD (wk4: 58-65 min; wk54: 60-78 min; all P < 0.0001) and reductions in OFF (wk4: 50-61 min; wk54: 56-68 min; all P < 0.0001). At weeks 4 and 54, patients' motor-state transitions were reduced by about half (IRR: 0.53 and 0.49, both P < 0.0001), and fewer patients experienced extreme fluctuations (OR: 0.22 and 0.15, both P < 0.0001).

Conclusion

CLES monotherapy was associated with significant long-term reductions in motor-state fluctuations, faster time to ON-woTD upon awakening, and increased symptom control throughout the day.

SUBMITTER: Pahwa R 

PROVIDER: S-EPMC9803946 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

altmetric image

Publications

Long-term results of carbidopa/levodopa enteral suspension across the day in advanced Parkinson's disease: Post-hoc analyses from a large 54-week trial.

Pahwa Rajesh R   Aldred Jason J   Merola Aristide A   Gupta Niodita N   Terasawa Emi E   Garcia-Horton Viviana V   Steffen David R DR   Kandukuri Prasanna L PL   Bao Yanjun Y   Ladhani Omar O   Yan Connie H CH   Chaudhari Vivek V   Isaacson Stuart H SH  

Clinical parkinsonism & related disorders 20221220


<h4>Introduction</h4>Carbidopa/levodopa enteral suspension (CLES) previously demonstrated reduction in total daily OFF from baseline by over 4 hours in advanced Parkinson's disease patients across 54 weeks. Evidence on CLES's long-term effectiveness on patterns of motor-symptom control throughout the day remains limited.<h4>Methods</h4>We present post-hoc analyses of a large, open-label study of CLES monotherapy (N = 289). Diary data recorded patients' motor states at 30-minute intervals over 3   ...[more]

Similar Datasets

| S-EPMC9095782 | biostudies-literature
| S-EPMC5349373 | biostudies-literature
| S-EPMC7396832 | biostudies-literature
| S-EPMC3798100 | biostudies-literature
| S-EPMC8068706 | biostudies-literature
| S-EPMC9290931 | biostudies-literature
| S-EPMC4559582 | biostudies-other
| S-EPMC4168384 | biostudies-literature
| S-EPMC5066747 | biostudies-literature
| S-EPMC7604637 | biostudies-literature