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
James Tetrud, Paul Nausieda, David Kreitzman, Grace S Liang, Anette Nieves, Andrew P Duker, Robert A Hauser, Eric S Farbman, Aaron Ellenbogen, Ann Hsu, Sherron Kell, Sarita Khanna, Robert Rubens, Suneel Gupta, James Tetrud, Paul Nausieda, David Kreitzman, Grace S Liang, Anette Nieves, Andrew P Duker, Robert A Hauser, Eric S Farbman, Aaron Ellenbogen, Ann Hsu, Sherron Kell, Sarita Khanna, Robert Rubens, Suneel Gupta
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.
Keywords: Carbidopa; Carbidopa and levodopa controlled-release; Carbidopa and levodopa extended-release; Dose conversion; IPX066; Levodopa; Parkinson's disease.
Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.
Source: PubMed