Waters, Cheryl H. and Nausieda, Paul and Dzyak, Lyudmila and Spiegel, Joerg and Rudzinska, Monika and Silver, Dee E. and Tsurkalenko, Elena S. and Kell, Sherron and Hsu, Ann and Khanna, Sarita and Gupta, Suneel (2015) Long-Term Treatment with Extended-Release Carbidopa– Levodopa (IPX066) in Early and Advanced Parkinson’s Disease: A 9-Month Open-Label Extension Trial. CNS Drugs, Vol.29 (No 4). pp. 341-350. ISSN 1172-7047 (print), 1179-1934 (online)
|
Text
Waters2015_Article_Long-TermTreatmentWithExtended.pdf Download (614kB) | Preview |
Abstract
Background and Objective IPX066 is a multiparticulate extended-release formulation of carbidopa–levodopa, designed to produce prolonged therapeutic levodopa plasma concentrations. This 9-month open-label extension study assessed its long-term safety and clinical utility in early and advanced Parkinson’s disease (PD). Methods Participants were enrolled from two phase III IPX066 studies and one open-label phase II study. Early PD patients were titrated to an appropriate dosing regimen while advanced patients started with regimens established in the antecedent studies. Adjustment was allowed throughout the extension. Clinical utility measures included the Unified Parkinson’s Disease Rating Scale (UPDRS) and Patient Global Impression (PGI) ratings. Results Among 268 early PD patients, 53.4 % reported adverse events (AEs) and 1.1 % (three patients) discontinued due to AEs; the most frequent AEs were nausea (5.6 %) and insomnia (5.6 %). Among 349 advanced patients, 60.2 % reported AEs and 3.7 % (13 patients) discontinued due to AEs; the most frequent AEs were dyskinesia (6.9 %) and fall (6.6 %). At month 9 (or early termination), 78.3 % of early patients were taking IPX066 three times daily (median: 720 mg/day) and 87.7 % of advanced patients were taking IPX066 three or four times daily (median: 1450 mg/day). Adjusting for 70 % bioavailability relative to immediate-release (IR) carbidopa–levodopa, the median dosages correspond to *500 and *1015 mg/day of IR levodopa in early and advanced PD, respectively. Based on the plasma profiles previously observed in PD patients, the IPX066 regimens in the extension can be estimated to provide a levodopa Cmax (maximum plasma drug concentration) similar to or lower than that provided by IR regimens during the antecedent trials. UPDRS and PGI findings showed sustained treatment effects throughout the extension. Conclusion During 9 months of extended use, IPX066 exhibited a safety/tolerability profile consistent with dopaminergic PD therapy.
| Item Type: | Article |
|---|---|
| Additional Information: | DOI 10.1007/s40263-015-0242-2 |
| Uncontrolled Keywords: | Throughout 9 months of extended, open-label treatment, IPX066, an investigational formulation of carbidopa–levodopa, showed acceptable long-term safety and tolerability in early and advanced Parkinson’s disease (PD). |
| Subjects: | Neurological disease |
| Divisions: | Faculty of Postgraduate Education > Department of Neurology and Neurosurgery FPE |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 24 Sep 2018 07:49 |
| Last Modified: | 24 Sep 2018 07:49 |
| URI: | http://repo.dma.dp.ua/id/eprint/3234 |
Actions (login required)
 |
View Item |
