Long-term real-world effectiveness of carbidopa/levodopa enteral suspension after 36 months of treatment initiation in advanced Parkinson's disease in the US: final results from the PROviDE study.
Long-term real-world effectiveness of carbidopa/levodopa enteral suspension after 36 months of treatment initiation in advanced Parkinson's disease in the US: final results from the PROviDE study.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
US · Author affiliation · country only
University of Kansas Medical Center, Kansas City, KS, USA.Location evidence
Boca Raton, US · Author affiliation
Parkinson's Disease and Movement Disorders Center, Boca Raton, FL, USA.Location evidence
Chicago, US · Author affiliation
Northwestern University, Chicago, IL, USA.Location evidence
Irvine, US · Author affiliation
OC Parkinson's Clinic, Irvine, CA, USA.Location evidence
North Chicago, US · Author affiliation
AbbVie Inc., North Chicago, IL, USA.Location evidence
King of Prussia, US · Author affiliation
United BioSource LLC, King of Prussia, PA, USA.Location evidence
Spokane, US · Author affiliation
Selkirk Neurology, Spokane, WA, USA.Location evidence
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Original abstract
Introduction: Clinical trials and observational studies have demonstrated that carbidopa/levodopa enteral suspension (CLES) significantly improves advanced Parkinson's disease (aPD) symptoms. This study examined the real-world, long-term impact of CLES on patient-reported outcomes (PROs) in people with aPD. Methods: Pursuing Real-World Outcomes via Duopa Ecosystem (PROviDE) was a 36-month prospective, observational study evaluating the effectiveness of CLES in patients with aPD in the US. PROs were collected at baseline, 3 months, and every 6 months after CLES initiation and included OFF-time, Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9), and Parkinson's Disease Questionnaire-8 (PDQ-8) assessing PD-related quality of life (QoL). Longitudinal treatment effects were evaluated using mixed-effect models. Results: Of 104 patients, 47 (45.2%) provided 36 months of data and were evaluated in the final mixed-model analysis. Patients mean standard deviation (SD) age was 67.0 (8.7) years with a mean (SD) PD diagnosis of 11.0 (6.2) years. Compared with baseline, CLES resulted in statistically significant and clinically meaningful improvements in hours of OFF-time as early as month 3 (mean: -2.7 h/day, p < .0001) and sustained at month 36 (-1.7 h/day, p = .004). Improvements were also observed in treatment effectiveness (≥19 points, all p < .0001), global satisfaction with treatment and convenience of therapy (≥10 points each; all p < .001) over 36 months. A statistically significant improvement in PDQ-8 was observed as early as month 3 (-4.1, p = .001) with no worsening over time. Conclusion: Long-term treatment with CLES provides significant and clinically meaningful reduction in OFF-time, patient's treatment satisfaction, and maintained QoL in the real-world setting.