1. Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease.
- Author
-
Tetrud J, Nausieda P, Kreitzman D, Liang GS, Nieves A, Duker AP, Hauser RA, Farbman ES, Ellenbogen A, Hsu A, Kell S, Khanna S, Rubens R, and Gupta S
- Subjects
- Aged, Aged, 80 and over, Antiparkinson Agents adverse effects, Carbidopa adverse effects, Delayed-Action Preparations, Drug Administration Schedule, Drug Combinations, Drug Substitution, Female, Humans, Levodopa adverse effects, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Antiparkinson Agents therapeutic use, Carbidopa therapeutic use, Levodopa therapeutic use, Parkinson Disease drug therapy
- Abstract
Background: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD)., Methods: In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance., Results: Among 43 patients initiated on IPX066, 33 completed conversion. The mean LD conversion ratio was 1.8 among 30 patients previously on CR plus IR (and 1.5 among 3 previously taking CR alone). The mean IPX066 dosing frequency was 3.5times/day compared with 2.6times/day for CR plus 4.6times/day for IR previously (and 4.7times/day for CR alone). By patient and clinician global improvement ratings after 6-month maintenance, ≥43.8% of patients were much or very much improved from their previous treatment, and ≥68.8% were at least minimally improved. Adverse events were consistent with those reported in prior IPX066 studies., Conclusions: These results suggest that advanced PD patients using CR CD-LD±IR can be safely converted to IPX066, with high likelihood of achieving a stable regimen, less frequent LD dosing, and improved overall clinical benefit., Trial Registration: Clinicaltrials.govNCT01411137., (Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2017
- Full Text
- View/download PDF