Safety and efficacy of levodopa-carbidopa intestinal gel: results from an open-label extension study in Japanese, Korean and Taiwanese patients with advanced Parkinson’s disease

Murata, Miho; Mihara, Masahito; Hasegawa, Kazuko; Jeon, Beomseok; Tsai, Chon Haw; Nishikawa, Noriko; Oeda, Tomoko; Yokoyama, Masayuki; Robieson, Weining; Chatamra, Krai; Facheris, Maurizio; Benesh, Janet

doi:10.1177/1756286418759315

Cited by 9 publications

(8 citation statements)

References 21 publications

(34 reference statements)

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“…Patient populations in four of the six aforementioned studies were predominantly white. However, similar efficacy and safety results have also been reported in Asian patients with PD [ 20 , 21 ].…”

Section: Introductionsupporting

confidence: 68%

A post hoc comparison of levodopa-carbidopa intestinal gel daytime monotherapy vs polytherapy safety and efficacy in patients with advanced Parkinson's disease: Results from 6 phase 3/3b open-label studies

Boyd¹,

Zadikoff²,

Benesh³

et al. 2020

Clinical Parkinsonism & Related Disorders

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Introduction As Parkinson's disease (PD) progresses, the number/frequency of PD medications tend to increase, which is correlated with decreased patient compliance and suboptimal control of PD symptoms. We investigated efficacy and safety of levodopa-carbidopa intestinal gel (LCIG) daytime monotherapy (with or without nighttime oral levodopa-carbidopa) compared with polytherapy (LCIG with ≥1 adjunctive PD therapy) in advanced PD patients. Methods This post hoc descriptive study compared LCIG stable daytime monotherapy with LCIG stable polytherapy in all six phase 3/3b open-label studies from both US and international sites; because of study design variability, pooling data for comparison was not appropriate. Efficacy assessments included PD diary data (mean change from baseline in “Off” time and “On” time with or without troublesome dyskinesia), mean Unified PD Rating Scale scores (Parts II and III), and 39-item Parkinson's Disease Questionnaire (PDQ-39) summary index. Adverse events were also assessed. Results Overall, LCIG daytime monotherapy and polytherapy demonstrated similar efficacy/safety profiles in advanced PD patients, regardless of treatment duration or population. LCIG monotherapy vs. polytherapy groups experienced similar mean decreases in “Off” time (4.6 vs. 4.1 h/day) and similar increases in “On” time without troublesome dyskinesia (4.6 vs. 4.1 h/day). In most studies, PDQ-39 summary index scores were reduced from baseline by ≥5 points, regardless of patient population or study duration. Adverse events not related to the procedure/device were similar in both groups. Conclusion Our data suggest that, for appropriate patients, LCIG monotherapy can provide a more simplified treatment option with similar efficacy and safety.

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Section: Introductionsupporting

confidence: 68%

A post hoc comparison of levodopa-carbidopa intestinal gel daytime monotherapy vs polytherapy safety and efficacy in patients with advanced Parkinson's disease: Results from 6 phase 3/3b open-label studies

Boyd¹,

Zadikoff²,

Benesh³

et al. 2020

Clinical Parkinsonism & Related Disorders

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“…Actually, according to our search results, more studies focusing on LCIG for PD patients were self pre-and post-control observational studies and lack a control group. Most of them confirm the effectiveness and safety profile of LCIG in patients with advanced PD ( 11 , 37 – 42 ), especially in the long-term follow-up ( 43 – 46 ). Zibetti and Kruger et al also found the positive effects of LCIG infusion on sleep quality and quality of life in patients with advanced PD ( 47 , 48 ).…”

Section: Discussionmentioning

confidence: 52%

“…Zibetti and Kruger et al also found the positive effects of LCIG infusion on sleep quality and quality of life in patients with advanced PD ( 47 , 48 ). All included studies in this meta-analysis were performed in the USA and Europe, while Murata et al added that LCIG was also efficacious and tolerable in Japanese, Taiwanese, and Korean advanced PD patients ( 42 ). Interestingly, apart from the efficacy and safety, LCIG is also cost-effective for PD patients ( 49 ).…”

Section: Discussionmentioning

confidence: 99%

Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease: A Systematic Review and Meta-Analysis

Wang

Chen

2018

Front. Neurol.

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Background: Levodopa has been widely used and regarded as the most effective therapy for Parkinson's disease (PD), but long-term treatment with oral levodopa may result in motor fluctuations and involuntary movements (dyskinesias). There is evidence to suggest that Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) can effectively manage motor and non-motor complications in PD, but clinical studies investigating this have yielded inconsistent results. This systematic review and meta-analysis was performed to examine the efficacy and safety of LCIG for patients with PD.Methods: A systematic search was conducted to retrieve published data in the EMBASE, PubMed, and the Cochrane Library up to March 2018. Both efficiency and safety of LCIG were analyzed using pooled standardized mean differences (SMDs) or odds ratio (ORs) with 95% confidence interval (CIs).Results: Eight trials with 384 PD patients were included in the present study. Compared with the control group, LCIG significantly decreased off-time (SMD, −1.19; 95% CI, −2.25 to −0.12; p = 0.003) and increased on-time without troublesome dyskinesia (SMD, 0.55; 95% CI, 0.20 to 0.90; p = 0.002). However, no significant difference of LCIG was found in on-time with troublesome dyskinesia. There were no significant differences in UPDRS, Hoehn & Yahr and PDQ-39 scores. Besides, no significant differences in the drop-out and adverse effects.Conclusions: Continuous delivery of LCIG may offer a promising option for PD patients. More randomized double-blind controlled studies with large sample sizes were needed to further confirm the efficacy and safety of LCIG for PD patients.

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“…Since the publication of the phase III studies, observational studies in Belgium and Romania (Table 2), a small-scale observational study in Australia, a small-scale pilot study in Japan, and a small-scale study in Japanese, Taiwanese and Korean patients with advanced PD have consistently demonstrated reductions in 'off' time and increased 'on' time without troublesome dyskinesia [Pickut et al 2014;Othman et al 2015;Bajenaru et al 2016;Chang et al 2016;Murata et al 2016].…”

Section: Motor Symptomsmentioning

confidence: 99%

Levodopa-carbidopa enteral suspension in advanced Parkinson’s disease: clinical evidence and experience

Virhammar

Nyholm

2016

Ther Adv Neurol Disord

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Abstract:The duration of action of oral levodopa becomes shorter as Parkinson's disease (PD) progresses. Patients with advanced PD may develop potentially disabling motor fluctuations and abnormal involuntary movement (dyskinesia), which cannot be managed with optimized oral or transdermal PD medications. The progressively worsening symptoms can have a substantial impact on the patient quality of life (QoL). Levodopa-carbidopa intestinal gel (LCIG) is delivered continuously via a percutaneous endoscopic gastrostomy with a jejunal extension (PEG-J). LCIG is licensed for the treatment of levodopa-responsive advanced PD in individuals experiencing severe motor fluctuations and dyskinesia when available combinations of antiparkinsonian medications have not given satisfactory results. Initial evidence for the efficacy and tolerability of LCIG came from a number of small-scale studies, but recently, three prospective studies have provided higher quality evidence. A 12-week double-blind comparison of LCIG with standard levodopa therapy, a 52-week open-label study extension of the double-blind study, and a 54-week open-label safety study, demonstrated significant improvements in 'off' time and 'on' time without troublesome dyskinesia, and QoL measures that were maintained in the longer term. There are also observations that LCIG may be effective treatment for nonmotor symptoms (NMS) although the evidence is limited. There is a need for further research on the efficacy of LCIG in reducing NMS, dyskinesia and improving QoL. This review surveys the clinical evidence for the effectiveness and tolerability of LCIG in the management of advanced PD and highlights some practical considerations to help optimize treatment.

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Safety and efficacy of levodopa-carbidopa intestinal gel: results from an open-label extension study in Japanese, Korean and Taiwanese patients with advanced Parkinson’s disease

Cited by 9 publications

References 21 publications

A post hoc comparison of levodopa-carbidopa intestinal gel daytime monotherapy vs polytherapy safety and efficacy in patients with advanced Parkinson's disease: Results from 6 phase 3/3b open-label studies

A post hoc comparison of levodopa-carbidopa intestinal gel daytime monotherapy vs polytherapy safety and efficacy in patients with advanced Parkinson's disease: Results from 6 phase 3/3b open-label studies

Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease: A Systematic Review and Meta-Analysis

Levodopa-carbidopa enteral suspension in advanced Parkinson’s disease: clinical evidence and experience

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