Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10366124" target="_blank" >RIV/00216208:11110/17:10366124 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064165:_____/17:10366124

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.parkreldis.2017.09.018" target="_blank" >http://dx.doi.org/10.1016/j.parkreldis.2017.09.018</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.parkreldis.2017.09.018" target="_blank" >10.1016/j.parkreldis.2017.09.018</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry

Popis výsledku v původním jazyce

Introduction: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson&apos;s disease (PD) patients under routine clinical care. Methods: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naive patients (60% of patients) and partially retrospective for patients with &lt;=12 months of pre-treatment with LCIG (40% of patients). Hours of &quot;On&quot; and &quot;Off&quot; time were assessed with a modified version of the Unified Parkinson&apos;s Disease Rating Scale part IV items 32 and 39. Results: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in &quot;Off&quot; time (hours/day) (mean +- SD = -4.1 +- 3.5, P &lt; 0.001), &quot;On&quot; time with dyskinesia (hours/day) (-1.1 +- 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 +- 43.2, P &lt; 0.001) and individual domains scores, and Parkinson&apos;s Disease Questionnaire-8 item total score (-7.1 +- 21.0, P &lt; 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). Conclusions: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.

Název v anglickém jazyce

Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry

Popis výsledku anglicky

Introduction: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson&apos;s disease (PD) patients under routine clinical care. Methods: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naive patients (60% of patients) and partially retrospective for patients with &lt;=12 months of pre-treatment with LCIG (40% of patients). Hours of &quot;On&quot; and &quot;Off&quot; time were assessed with a modified version of the Unified Parkinson&apos;s Disease Rating Scale part IV items 32 and 39. Results: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in &quot;Off&quot; time (hours/day) (mean +- SD = -4.1 +- 3.5, P &lt; 0.001), &quot;On&quot; time with dyskinesia (hours/day) (-1.1 +- 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 +- 43.2, P &lt; 0.001) and individual domains scores, and Parkinson&apos;s Disease Questionnaire-8 item total score (-7.1 +- 21.0, P &lt; 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). Conclusions: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30103 - Neurosciences (including psychophysiology)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Parkinsonism and Related Disorders

ISSN

1353-8020

e-ISSN

—

Svazek periodika

45

Číslo periodika v rámci svazku

December

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

13-20

Kód UT WoS článku

000419811700003

EID výsledku v databázi Scopus

2-s2.0-85031330718