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Clinical Review Report: Levodopa/Carbidopa (Duodopa): (Abbvie Corporation): Indication: For the treatment of patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper-/dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products, and, for whom the benefits of this treatment may outweigh the risks associated with the insertion and long-term use of the percutaneous endoscopic gastrostomy-jejunostomy (PEG-J) tube required for administration [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Sep.

Cover of Clinical Review Report: Levodopa/Carbidopa (Duodopa)

Clinical Review Report: Levodopa/Carbidopa (Duodopa): (Abbvie Corporation): Indication: For the treatment of patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper-/dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products, and, for whom the benefits of this treatment may outweigh the risks associated with the insertion and long-term use of the percutaneous endoscopic gastrostomy-jejunostomy (PEG-J) tube required for administration [Internet].

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Abbreviations

ADL

activities of daily living

AE

adverse event

ANCOVA

analysis of covariance

AUROC

area under the receiver operating characteristics

CDR

CADTH Common Drug Review

CEDAC

Canadian Expert Drug Advisory Committee

CGI-I

Clinical Global Impression – Improvement

CGI-S

Clinical Global Impression – Severity

CI

confidence interval

CISI-PD

Clinical Impression of Severity Index for Parkinson Disease

COMT

catechol-O-methyltransferase

DB

double-blind

DBS

deep brain stimulation

DPAC-FWG

Drug Policy Advisory Committee Formulary Working Group

EPD

early Parkinson disease

EQ-5D-3L

EuroQol 5-Dimensions 3-Levels questionnaire

EQ VAS

EuroQol visual analogue scale

FAS

full analysis set

GI

gastrointestinal

HRQoL

health-related quality of life

HY

Hoehn and Yahr

ICC

interclass coefficient

IR

immediate-release

LCIG

levodopa/carbidopa intestinal gel

LOCF

last observation carried forward

LS

least squares

LSMD

least squares mean difference

MAO-B

monoamine oxidase type B

MCID

minimal clinically important difference

MDS

Movement Disorder Society

MMRM

mixed-effects models for repeated measures

NJ

nasojejunal

OLC

oral levodopa/carbidopa

PAA

Parkinson Association of Alberta

PBO

placebo

PC

Parkinson Canada

PD

Parkinson disease

PDHD

Parkinson disease home diary

PDQ-39

39-Item Parkinson’s Disease Questionnaire

PDQSI

Parkinson’s Disease Questionnaire — summary index

PEG-J

percutaneous endoscopic gastrostomy with jejunal extension

PGI-S

Patient Global Impression – Severity

PSBC

Parkinson Society British Columbia

QALY

quality-adjusted life-year

QoL

quality of life

RCT

randomized controlled trial

SAE

serious adverse event

SD

standard deviation

SE

standard error

SES

Schwab and England Scale

SF-36

Short Form (36) Health Survey

TEAE

treatment-emergent adverse event

UPDRS

Unified Parkinson’s Disease Rating Scale

VAS

visual analogue scale

ZBI

Zarit Burden Interview

Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK539561
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