Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease
Robert A Hauser,1 Aaron Ellenbogen,2 Sarita Khanna,3 Suneel Gupta,3 Nishit B Modi3 1Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, FL, USA; 2Quest Research Institute, Bingham Farms, MI, USA; 3Impax Laboratories, Inc., Hayward, CA, USA Backgrou...
Guardado en:
| Autores principales: | , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Dove Medical Press
2018
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/688a03100d9d4bfab5fa1ae90a6dd60d |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:688a03100d9d4bfab5fa1ae90a6dd60d |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:688a03100d9d4bfab5fa1ae90a6dd60d2021-12-02T01:35:39ZOnset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease1178-2021https://doaj.org/article/688a03100d9d4bfab5fa1ae90a6dd60d2018-03-01T00:00:00Zhttps://www.dovepress.com/onset-and-duration-of-effect-of-extended-release-carbidopa-levodopa-in-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Robert A Hauser,1 Aaron Ellenbogen,2 Sarita Khanna,3 Suneel Gupta,3 Nishit B Modi3 1Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, FL, USA; 2Quest Research Institute, Bingham Farms, MI, USA; 3Impax Laboratories, Inc., Hayward, CA, USA Background: In patients with Parkinson’s disease (PD), oral dosing of extended-release carbidopa-levodopa (Rytary, IPX066 [ER CD-LD]) achieves peak levodopa plasma concentrations within 1 hour and maintains them for 4–6 hours. Aims: To compare the onset and duration of ER CD-LD benefit with those of immediate-release carbidopa-levodopa (IR CD-LD) in PD patients with motor fluctuations, using crossover data, and to evaluate which threshold values of improvement in finger-tapping and Unified Parkinson’s Disease Rating Scale (UPDRS) motor scores yield results most similar to those for trained raters’ “on”/“off” assessments. Methods: Patients underwent serial “on”/“off” rating and provided serial finger-tapping and UPDRS motor scores after receiving, in an “off” state, their usual morning IR dose or an ER dose designed to produce a similar levodopa peak concentration. Predefined improvement thresholds for analysis were 10%, 15%, and 20% increases in finger-tapping score and 2.5, 5, 7, and 11-point decreases in UPDRS motor score. Serial plasma samples were assayed for levodopa. Results: Among 27 patients, mean time to onset of an “on” state was similar for ER compared with IR CD-LD (0.83 vs 0.81 hour), but mean duration was significantly longer for ER CD-LD than for IR CD-LD (5.56 vs 2.69 hours; P<0.0001). Duration was best matched by a ≥20% improvement in finger-tapping, a ≥11-point improvement in UPDRS motor score, and a levodopa plasma concentration ≥1,000 ng/mL. Conclusion: For ER CD-LD, observer assessments of “on” state were corroborated by sustained treatment effects. Correlations among “on”-state duration, finger-tapping score, and UPDRS motor score may suggest clinically relevant thresholds for acute assessment of treatment benefit. Keywords: Rytary, carbidopa-levodopa, Parkinson’s disease, treatment, duration of effect, motor fluctuationsHauser RAEllenbogen AKhanna SGupta SModi NBDove Medical Pressarticleextended-releasecarbidopa-levodopaduration of effectUPDRSfinger-tappingmotor fluctuationsNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 14, Pp 839-845 (2018) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
extended-release carbidopa-levodopa duration of effect UPDRS finger-tapping motor fluctuations Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 |
| spellingShingle |
extended-release carbidopa-levodopa duration of effect UPDRS finger-tapping motor fluctuations Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Hauser RA Ellenbogen A Khanna S Gupta S Modi NB Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| description |
Robert A Hauser,1 Aaron Ellenbogen,2 Sarita Khanna,3 Suneel Gupta,3 Nishit B Modi3 1Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, FL, USA; 2Quest Research Institute, Bingham Farms, MI, USA; 3Impax Laboratories, Inc., Hayward, CA, USA Background: In patients with Parkinson’s disease (PD), oral dosing of extended-release carbidopa-levodopa (Rytary, IPX066 [ER CD-LD]) achieves peak levodopa plasma concentrations within 1 hour and maintains them for 4–6 hours. Aims: To compare the onset and duration of ER CD-LD benefit with those of immediate-release carbidopa-levodopa (IR CD-LD) in PD patients with motor fluctuations, using crossover data, and to evaluate which threshold values of improvement in finger-tapping and Unified Parkinson’s Disease Rating Scale (UPDRS) motor scores yield results most similar to those for trained raters’ “on”/“off” assessments. Methods: Patients underwent serial “on”/“off” rating and provided serial finger-tapping and UPDRS motor scores after receiving, in an “off” state, their usual morning IR dose or an ER dose designed to produce a similar levodopa peak concentration. Predefined improvement thresholds for analysis were 10%, 15%, and 20% increases in finger-tapping score and 2.5, 5, 7, and 11-point decreases in UPDRS motor score. Serial plasma samples were assayed for levodopa. Results: Among 27 patients, mean time to onset of an “on” state was similar for ER compared with IR CD-LD (0.83 vs 0.81 hour), but mean duration was significantly longer for ER CD-LD than for IR CD-LD (5.56 vs 2.69 hours; P<0.0001). Duration was best matched by a ≥20% improvement in finger-tapping, a ≥11-point improvement in UPDRS motor score, and a levodopa plasma concentration ≥1,000 ng/mL. Conclusion: For ER CD-LD, observer assessments of “on” state were corroborated by sustained treatment effects. Correlations among “on”-state duration, finger-tapping score, and UPDRS motor score may suggest clinically relevant thresholds for acute assessment of treatment benefit. Keywords: Rytary, carbidopa-levodopa, Parkinson’s disease, treatment, duration of effect, motor fluctuations |
| format |
article |
| author |
Hauser RA Ellenbogen A Khanna S Gupta S Modi NB |
| author_facet |
Hauser RA Ellenbogen A Khanna S Gupta S Modi NB |
| author_sort |
Hauser RA |
| title |
Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| title_short |
Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| title_full |
Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| title_fullStr |
Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| title_full_unstemmed |
Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease |
| title_sort |
onset and duration of effect of extended-release carbidopa-levodopa in advanced parkinson’s disease |
| publisher |
Dove Medical Press |
| publishDate |
2018 |
| url |
https://doaj.org/article/688a03100d9d4bfab5fa1ae90a6dd60d |
| work_keys_str_mv |
AT hauserra onsetanddurationofeffectofextendedreleasecarbidopalevodopainadvancedparkinsonrsquosdisease AT ellenbogena onsetanddurationofeffectofextendedreleasecarbidopalevodopainadvancedparkinsonrsquosdisease AT khannas onsetanddurationofeffectofextendedreleasecarbidopalevodopainadvancedparkinsonrsquosdisease AT guptas onsetanddurationofeffectofextendedreleasecarbidopalevodopainadvancedparkinsonrsquosdisease AT modinb onsetanddurationofeffectofextendedreleasecarbidopalevodopainadvancedparkinsonrsquosdisease |
| _version_ |
1718402962441633792 |