Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To determine whether correcting for “off” time duration improves the selection of the final LD dose when converting to extended-release carbidopa-levodopa capsules (ER CD-LD, RYTARY®).
Background: The prescribing information for ER CD-LD provides a recommendation for converting Parkinson’s disease (PD) patients from immediate-release (IR) CD-LD and CD-LD-entacapone (CLE) to ER CD-LD based on the LD total daily dose.
Methods: We evaluated ER CD-LD dosing data from three studies (ADVANCE-PD, ASCEND-PD, and the long-term open-label extension [OLE]) in patients with advanced PD. For the OLE, the cohort of patients who converted from IR CD-LD to ER CD-LD was examined. A modified conversion (MC) that took into account whether patients had more or less “off” time at baseline (prestudy) than a threshold amount (4 or 5 hours) was compared to the current conversion (CC). In the MC, an additional 95 mg LD was recommended with each ER CD-LD dose when patients had more “off” time. The ratio of the recommended dose to final ER CD-LD dose that patients took for each conversion was estimated.
Results: 393 patients completed conversion to ER CD-LD in ADVANCE-PD, 91 patients completed conversion in ASCEND-PD, and 163 patients converted from IR CD-LD to ER CD-LD during the OLE. The following table summarizes median conversion ratios.[table1] Using the amount of baseline “off” time during IR CD-LD or CLE treatment in selecting the ER CD-LD dose resulted in a better estimate of the final dose. Converting from CLE to ER CD-LD requires an approximately 23-29% increase in LD dose.
Conclusions: Using “off” time in the selection of the ER CD-LD dose resulted in doses that were closer to the actual ER CD-LD doses. Converting from CLE to ER CD-LD requires approximately a 23-29% higher LD dose.
Abstract submitted for presentation at the 2017 meeting of the American Academy of Neurology.
To cite this abstract in AMA style:
N. Modi, S. Khanna, S. Gupta. Post-hoc analyses of the recommended starting dose for Rytary based on “off” time [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/post-hoc-analyses-of-the-recommended-starting-dose-for-rytary-based-on-off-time/. Accessed May 21, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/post-hoc-analyses-of-the-recommended-starting-dose-for-rytary-based-on-off-time/