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

Antonini, Angelo; Poewe, Werner; Chaudhuri, K. Ray; Jech, Robert; Pickut, Barbara A.; Pirtošek, Zvezdan; Szász, József Attila; Valldeoriola, Francesc; Winkler, Christian; Bergmann, Lars; Yegin, Ashley; Onuk, Koray; David, Vincent; Odin, Per; Amalia, Ene; Arnold, G.; Băjenaru, Ovidiu; Bergmans, Bruno; Bjørnarå, Kari Anne; Blackie, Jeff; Bode, Matthias; Bourgeois, Paul; Bohlhalter, Stephan; Buraga, Ioan; Burkhard, Pierre; Busson, P.; Calopa, Matilde; Clausen, Jesper O.; Danielsen, Erik Hvid; Defebvre, Luc; Delvaux, Valérie; Dethy, Sophie; Dietrichs, Espen; Fábregues, Oriol de; Gerhard, Ransmayr; Gusmaroli, Graziano; Hahn, Kirsten; Hauptmann, Björn; Henriksen, Tove; Hernández‐Vara, Jorge; Jeanjean, Anne; Kaiserová, Michaela; Kassubek, Jan; Kimber, Thomas; Konitsiotis, Spyridon; Krüger, Rejko; Kulisevsky, Jaime; Leenders, Jo; Lundqvist, Christofer; Magné, Frédéric; Marano, Pietro; Milanov, Ivan; Modugno, Nicola; Misbahuddin, Anjum; Nevrlý, Martin; Panayiotis, Zikos; Pedersen, Kenn Freddy; Pedersen, Stephen Wørlich; Perju‐Dumbravă, Lăcrămioara; Ponsen, M.M.; Popescu, Bogdan Ovidiu; Rijntjes, Michel; Puente, Víctor; Redecker, Christoph; Schrader, Christoph; Sensi, Mariachiara; Simu, Mihaela; Spanaki, Cleanthe; Storch, Alexander; Storstein, Anette; Tomantschger, Volker; Linden, Chris van der; Laar, Teus van; Viallet, François; Witjas, Tatiana; Wolz, Martin; Zibetti, Maurizio; Zandijcke, M. Van

doi:10.1016/j.parkreldis.2017.09.018

Cited by 166 publications

(251 citation statements)

References 26 publications

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“…Similar observations were reported in another study: the NMSS domains sleep/fatigue, mood/apathy and attention/memory were most significantly predictive of QoL change . Sleep in PD is a complex phenomenon driven by various neurotransmitter system abnormalities . However, a considerable element of sleep dysfunction in PD is dopaminergic and consequently in theory responsive to levodopa therapy.…”

Section: Discussionsupporting

confidence: 86%

“…The analysis of the GLORIA database included assessments of motor and non‐motor symptoms and QoL with results comparable to a number of recent studies . The results of this first, large multinational, long‐term registry demonstrated sustained improvements with LCIG of motor and non‐motor symptoms and in NMSS subdomains (particularly sleep/fatigue, mood/cognition and gastrointestinal domains), as well as QoL in advanced PD patients at 12 and 24 months .…”

Section: Discussionmentioning

confidence: 60%

“…The ADRs have been described in the interim and final publication of the GLORIA registry and did not show any new findings compared to the known safety profile of LCIG.…”

Section: Resultsmentioning

confidence: 97%

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Burden of non‐motor symptoms in Parkinson's disease patients predicts improvement in quality of life during treatment with levodopa‐carbidopa intestinal gel

Antonini

Robieson

Sánchez-Soliño

et al. 2018

Euro J of Neurology

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Background and purpose GLORIA , a registry conducted with 375 advanced Parkinson's disease patients treated with levodopa‐carbidopa intestinal gel ( LCIG ) for 24 months in routine clinical care, demonstrated significant reductions from baseline in ‘off’ time and ‘on’ time with dyskinesia and improvements in the Non‐Motor Symptom Scale ( NMSS ) total and individual domain scores, and in Parkinson's Disease Questionnaire 8 item ( PDQ ‐8) total score. Methods Associations between baseline NMSS burden ( NMSB ), the multi‐domain NMSS total score and the PDQ ‐8 total score were investigated for 233 patients. Baseline NMSB was assigned to five numerical categories defined by the NMSS total cutoff scores (0–20, 21–40, 41–60, 61–80 and >80). Pearson and Spearman correlations were calculated at month 24. Results The response of LCIG was assessed using validated criteria after 24 months. The proportion of patients decreasing ≥ 30 NMSS score points was 47% in the most affected NMSB category ( NMSS total score > 80). A positive association was noted between baseline NMSB and NMSS total score (0.57, P < 0.0001), as well as between NMSS total score and PDQ ‐8 total score (0.46, P < 0.0001). Associations between improvements of the NMSS domain sleep/fatigue and PDQ ‐8 total score (0.32, P = 0.0001) as well as between the NMSS domain mood/cognition and PDQ ‐8 total score (0.37, P < 0.0001) were also shown. Conclusions This analysis demonstrated positive associations between NMSS baseline burden and improvements of non‐motor symptoms. Improvements of non‐motor symptoms were associated with improved quality of life in advanced parkinsonian patients during a 2‐year treatment with LCIG and reflect the long‐term non‐motor efficacy of this treatment.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 60%

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Burden of non‐motor symptoms in Parkinson's disease patients predicts improvement in quality of life during treatment with levodopa‐carbidopa intestinal gel

Antonini

Robieson

Sánchez-Soliño

et al. 2018

Euro J of Neurology

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“…This is supported by several uncontrolled observations that indicate that spontaneous pain may be minimized by strategies such as continuous dopaminergic release and stimulation (e.g. apomorphine/levodopa infusion and deep brain stimulation) that usually improve levodopa‐related motor complications . However, because of the lack of a placebo group, these observations need to be considered with caution.…”

Section: Impact Of Dopaminergic Medication On Pain and Pain‐processinmentioning

confidence: 99%

Pain in Parkinson's disease: facts and uncertainties

Antonini

Tinazzi

Abbruzzese

et al. 2018

Euro J of Neurology

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Pain is one of the most common and troublesome non-motor symptoms of Parkinson's disease (PD). It can appear at any time during the disease and is often present before diagnosis. However, there is little or no consensus on its definition. An expert group of clinicians with relevant research experience met to review the existing evidence and to identify gaps in our understanding leading towards AUTHOR: 'understanding towards' has been changed to 'understanding leading towards'. Please check and confirm that this is appropriate an optimized therapy of pain in PD. Key findings from epidemiologic, neurophysiologic, neuroimaging and clinical studies are reviewed. In each case, the evidence base is limited by wide variations in the definitions of pain applied, study methodologies and populations evaluated. Disease-related and medical conditions trigger spontaneous pain in patients with PD, which is then abnormally processed and results in painful manifestations in specific body parts. Dopaminergic medications, such as rotigotine, as well as opiate analgesics, such as oxycodone, have shown positive results but future studies with more detailed pain characterization at inclusion are warranted.

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“…It is believed that introducing LCIG significantly improves specific nonmotor symptoms in advanced PD patients, enhances quality of life, and facilitates daily living activities (Krüger et al, ). Furthermore, a 2‐year observational study of the clinical safety and effectiveness of LCIG showed that the treatment significantly shortened off‐time, decreased dyskinesia, and improved nonmotor symptom in advanced PD patients (Antonini et al, ).…”

Section: Introductionmentioning

confidence: 99%

Proposition of zinc supplementation during levodopa–carbidopa intestinal gel treatment

et al. 2018

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ObjectivesLevodopa–carbidopa intestinal gel (LCIG) infusion is a useful therapy for the wearing‐off phenomenon of advanced Parkinson's disease (PD) patients. Recently, we found three PD patients that may have had a zinc deficiency after the LCIG infusion, possibly due to the zinc‐chelating action of levodopa. This study aims to evaluate changes in serum zinc levels in three patients that received LCIG treatment and to determine possible remedies for zinc deficiency during treatment.Materials and MethodsWe performed a prospective blood analysis of serum zinc levels before, when possible, and after LCIG treatment in our three PD patients.ResultsThe serum zinc levels of the first patient before treatment and 4 months after beginning LCIG treatment were 69 and 58 μg/dl, respectively. For the second patient, serum zinc levels before treatment and two months after starting LCIG treatment were 87 and 46 μg/dl, respectively. The baseline serum zinc level for the third patient was not examined, but was 48 μg/dl 5 months after starting the LCIG infusion.ConclusionsLevodopa–carbidopa intestinal gel infusion might have caused a zinc deficiency through levodopa zinc chelation. Zinc deficiency with LCIG infusion has not yet been reported, though preventing zinc deficiency may be an important factor in future LCIG treatment strategies.

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

Cited by 166 publications

References 26 publications

Burden of non‐motor symptoms in Parkinson's disease patients predicts improvement in quality of life during treatment with levodopa‐carbidopa intestinal gel

Burden of non‐motor symptoms in Parkinson's disease patients predicts improvement in quality of life during treatment with levodopa‐carbidopa intestinal gel

Pain in Parkinson's disease: facts and uncertainties

Proposition of zinc supplementation during levodopa–carbidopa intestinal gel treatment

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