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

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• 作者：James Tetrud^a ; ¹ ; ^{jtetrud@stanford.edu} ; Paul Nausieda^b ; ^{nausiedamd@parkcent.com} ; David Kreitzman^c ; ^{PDMDCLI@aol.com} ; Grace S. Liang^a ; ² ; ^{graceliangmd@gmail.com} ; Anette Nieves^d ; ^{Anette_Nieves@munroeregional.com} ; Andrew P. Duker^e ; ^{dukeraa@ucmail.uc.edu} ; Robert A. Hauser^f ; ^{rhauser@health.usf.edu} ; Eric S. Farbman^g ; ^{efarbman@medicine.nevada.edu} ; Aaron Ellenbogen^h ; ^{aellenbogen@comcast.net} ; Ann Hsuⁱ ; ^{annhsu@aol.com} ; Sherron Kellⁱ ; ^{skell@impaxlabs.com} ; Sarita Khannaⁱ ; ^{skhanna@impaxlabs.com} ; Robert Rubensⁱ ; ^{rrubens@impaxlabs.com} ; Suneel Guptaⁱ ; ^{sgupta@impaxlabs.com}
• 关键词：AEs ; adverse events ; CD ; carbidopa ; CGI ; Clinical Global Impression ; COMT ; catechol-O-methyltransferase ; CR ; controlled-release ; C-SSRS ; Columbia-Suicide Severity Rating Scale ; IR ; immediate-release ; LD ; levodopa ; MAO ; monoamine oxidase ; OPDM ; Objective Parkinson's Disease Measurement ; PD ; Parkinson's disease ; PDQ-8 ; 8-item Parkinson's Disease Questionnaire ; PGI ; Patient Global Impression ; SAEs ; serious AEs ; SD ; standard deviation ; SE ; standard error ; TID ; 3  ; times/day ; UPDRS ; Unified Parkin
• 刊名：Journal of the Neurological Sciences
• 出版年：2017
• 出版时间：15 February 2017
• 年：2017
• 卷：373
• 期：Complete
• 页码：116-123
• 全文大小：430 K
• 卷排序：373

文摘

IPX066 achieves therapeutic LD plasma concentration by 1 h and maintains them for 4–5 h before declining Open-label conversion of PD patients on CR CD-LD ± IR to IPX066. Treatment was between 6 and 12 m UPDRS Part III scores significantly improved, favoring IPX066 at 4 and 5 h post-dose (p < .05 and p < .01) 65.6% of patients preferred IPX066; 12.5% preferred their previous therapy; 21.9% had no preference PD patients on CR CD-LD ± IR were switched safely to IPX066. By 6-m ≥ 68.8% experienced meaningful clinical benefit