Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients

Angelo Antonini, Victor S C Fung, James T. Boyd, John T. Slevin, Coleen Hall, Krai Chatamra, Susan Eaton, Janet A. Benesh

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Objective: The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia. Methods: Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n=11 levodopa-carbidopa intestinal gel, n=12 oral levodopa-carbidopa; open label: n=144 levodopa-carbidopa intestinal gel). The changes in "off" time, "on" time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed. Results: Although not significantly different from oral levodopa treatment (P>.05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in "on" time with troublesome dyskinesia (mean [standard deviation] hours: baseline=3.1 [1.7], change from baseline to final=-1.8 [1.8], P=.014), increase in "on" time without troublesome dyskinesia (baseline=7.4 [2.2], change=4.4 [3.6], P=.004), and decrease in "off" time (baseline=5.5 [1.3], change=-2.7 [2.8], P=.015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased "on" time with troublesome dyskinesia in either study (double blind: r=-.073, P=.842; open label: r=-0.001, P=.992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure. Conclusion: Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.

Original languageEnglish
JournalMovement Disorders
DOIs
Publication statusAccepted/In press - 2016

Fingerprint

Dyskinesias
Parkinson Disease
Gels
Double-Blind Method
Levodopa
levodopa drug combination carbidopa
Small Intestine
Suspensions
Safety
Therapeutics

Keywords

  • Carbidopa-levodopa enteral suspension
  • Dyskinesia
  • Infusion
  • Levodopa-carbidopa intestinal gel
  • Parkinson's disease
  • Percutaneous endoscopic gastrojejunostomy

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Antonini, A., Fung, V. S. C., Boyd, J. T., Slevin, J. T., Hall, C., Chatamra, K., ... Benesh, J. A. (Accepted/In press). Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients. Movement Disorders. https://doi.org/10.1002/mds.26528

Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients. / Antonini, Angelo; Fung, Victor S C; Boyd, James T.; Slevin, John T.; Hall, Coleen; Chatamra, Krai; Eaton, Susan; Benesh, Janet A.

In: Movement Disorders, 2016.

Research output: Contribution to journalArticle

Antonini, A, Fung, VSC, Boyd, JT, Slevin, JT, Hall, C, Chatamra, K, Eaton, S & Benesh, JA 2016, 'Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients', Movement Disorders. https://doi.org/10.1002/mds.26528
Antonini, Angelo ; Fung, Victor S C ; Boyd, James T. ; Slevin, John T. ; Hall, Coleen ; Chatamra, Krai ; Eaton, Susan ; Benesh, Janet A. / Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients. In: Movement Disorders. 2016.
@article{d553c0e1af794d0193ce3212d8d93a67,
title = "Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients",
abstract = "Objective: The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia. Methods: Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of {"}on{"} time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n=11 levodopa-carbidopa intestinal gel, n=12 oral levodopa-carbidopa; open label: n=144 levodopa-carbidopa intestinal gel). The changes in {"}off{"} time, {"}on{"} time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed. Results: Although not significantly different from oral levodopa treatment (P>.05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in {"}on{"} time with troublesome dyskinesia (mean [standard deviation] hours: baseline=3.1 [1.7], change from baseline to final=-1.8 [1.8], P=.014), increase in {"}on{"} time without troublesome dyskinesia (baseline=7.4 [2.2], change=4.4 [3.6], P=.004), and decrease in {"}off{"} time (baseline=5.5 [1.3], change=-2.7 [2.8], P=.015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased {"}on{"} time with troublesome dyskinesia in either study (double blind: r=-.073, P=.842; open label: r=-0.001, P=.992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure. Conclusion: Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.",
keywords = "Carbidopa-levodopa enteral suspension, Dyskinesia, Infusion, Levodopa-carbidopa intestinal gel, Parkinson's disease, Percutaneous endoscopic gastrojejunostomy",
author = "Angelo Antonini and Fung, {Victor S C} and Boyd, {James T.} and Slevin, {John T.} and Coleen Hall and Krai Chatamra and Susan Eaton and Benesh, {Janet A.}",
year = "2016",
doi = "10.1002/mds.26528",
language = "English",
journal = "Movement Disorders",
issn = "0885-3185",
publisher = "John Wiley and Sons Inc.",

}

TY - JOUR

T1 - Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients

AU - Antonini, Angelo

AU - Fung, Victor S C

AU - Boyd, James T.

AU - Slevin, John T.

AU - Hall, Coleen

AU - Chatamra, Krai

AU - Eaton, Susan

AU - Benesh, Janet A.

PY - 2016

Y1 - 2016

N2 - Objective: The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia. Methods: Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n=11 levodopa-carbidopa intestinal gel, n=12 oral levodopa-carbidopa; open label: n=144 levodopa-carbidopa intestinal gel). The changes in "off" time, "on" time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed. Results: Although not significantly different from oral levodopa treatment (P>.05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in "on" time with troublesome dyskinesia (mean [standard deviation] hours: baseline=3.1 [1.7], change from baseline to final=-1.8 [1.8], P=.014), increase in "on" time without troublesome dyskinesia (baseline=7.4 [2.2], change=4.4 [3.6], P=.004), and decrease in "off" time (baseline=5.5 [1.3], change=-2.7 [2.8], P=.015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased "on" time with troublesome dyskinesia in either study (double blind: r=-.073, P=.842; open label: r=-0.001, P=.992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure. Conclusion: Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.

AB - Objective: The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia. Methods: Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n=11 levodopa-carbidopa intestinal gel, n=12 oral levodopa-carbidopa; open label: n=144 levodopa-carbidopa intestinal gel). The changes in "off" time, "on" time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed. Results: Although not significantly different from oral levodopa treatment (P>.05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in "on" time with troublesome dyskinesia (mean [standard deviation] hours: baseline=3.1 [1.7], change from baseline to final=-1.8 [1.8], P=.014), increase in "on" time without troublesome dyskinesia (baseline=7.4 [2.2], change=4.4 [3.6], P=.004), and decrease in "off" time (baseline=5.5 [1.3], change=-2.7 [2.8], P=.015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased "on" time with troublesome dyskinesia in either study (double blind: r=-.073, P=.842; open label: r=-0.001, P=.992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure. Conclusion: Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.

KW - Carbidopa-levodopa enteral suspension

KW - Dyskinesia

KW - Infusion

KW - Levodopa-carbidopa intestinal gel

KW - Parkinson's disease

KW - Percutaneous endoscopic gastrojejunostomy

UR - http://www.scopus.com/inward/record.url?scp=84958211503&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84958211503&partnerID=8YFLogxK

U2 - 10.1002/mds.26528

DO - 10.1002/mds.26528

M3 - Article

AN - SCOPUS:84958211503

JO - Movement Disorders

JF - Movement Disorders

SN - 0885-3185

ER -