Levodopa/carbidopa/entacapone versus levodopa/dopa-decarboxyiase inhibitor for the treatment of Parkinson's disease: systematic review, meta-analysis, and economic evaluation

Therapeutics and Clinical Risk Management, Apr 2018

Levodopa/carbidopa/entacapone versus levodopa/dopa-decarboxyiase inhibitor for the treatment of Parkinson's disease: systematic review, meta-analysis, and economic evaluation Zhan-Miao Yi,1–3 Ting-Ting Qiu,1,4 Yuan Zhang,5 Na Liu,6 Suo-Di Zhai1,3 1Department of Pharmacy, Peking University Third Hospital, 2Department of Pharmacy Administration and Clinical Pharmacy, Peking University School of Pharmaceutical Science, 3Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China; 4Public Health Department, Aix-Marseille University, Marseille, France; 5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; 6Department of Neurology, Peking University Third Hospital, Beijing, China Aims: To review the evidence for efficacy, safety, and cost-effectiveness of levodopa/carbidopa/entacapone (LCE) compared with levodopa/dopa-decarboxyiase inhibitor (DDCI) for Parkinson’s disease (PD).Methods: PubMed, Embase, the Cochrane Library, and Chinese databases WangFang Data, Chinese Sci-tech Journals Database and China National Knowledge Infrastructure, as well as ClinicalTrials.gov, were searched for randomized controlled trials with “levodopa/carbidopa/entacapone” as keywords. The search period was from inception to August 2017. We conducted meta-analyses to synthesize the evidence quantitatively.Results: A total of 5,693 records were obtained. We included seven randomized controlled trials and one cost-effectiveness study after the screening process. Compared with levodopa–DDCI, LCE improved patient Unified Parkinson’s Disease Rating Scale (UPDRS) II score (mean difference [MD] -1.17, 95% CI -1.64 to -0.71), UPDRS III score (MD -1.55, 95% CI -2.29 to -0.81), and Schwab and England daily activity rating (MD 2.05, 95% CI 0.85–3.26). There was no statistically significant difference in the risk of serious adverse events (AEs) or discontinuation due to AEs in patients with LCE, and the risk of total AEs was higher in the LCE group (risk ratio [RR] 1.33, 95% CI 1.05–1.70). The incremental cost-effectiveness ratio of LCE was £3,105 per quality-adjusted life-year (QALY) gained in the UK.Conclusion: LCE can improve PD patients’ motor symptoms and daily living functioning when compared with levodopa/DDCI. Keywords: Unified Parkinson’s Disease Rating Scale, quality of life, wearing off, adverse events, cost-effectiveness, health technology assessment

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Levodopa/carbidopa/entacapone versus levodopa/dopa-decarboxyiase inhibitor for the treatment of Parkinson's disease: systematic review, meta-analysis, and economic evaluation

Therapeutics and Clinical Risk Management levodopa/carbidopa/entacapone versus levodopa/ dopa-decarboxyiase inhibitor for the treatment of Parkinson's disease: systematic review, meta- analysis, and economic evaluation Zhan-Miao Yi 1 3 Ting-Ting Qiu 1 3 6 Yuan Zhang 1 5 0 institute for Drug evaluation, Peking University health science Center , Beijing , China 1 Methods: PubMed , Embase, the Cochrane Library, and Chinese databases WangFang Data 2 Department of Pharmacy administration and Clinical Pharmacy, Peking University s chool of Pharmaceutical science 3 Department of Pharmacy, Peking University Third hospital 4 Department of n eurology, Peking University Third hospital , Beijing , China 5 Department of h ealth Research Methods , evidence, and impact , McMaster University , hamilton, On , Canada 6 Public health Department, aix-Marseille University , Marseille , France 8 1 0 2 - l u J - 2 1 n o 7 0 2 . 6 4 . 9 5 . 7 3 y b / m o c . s s e r p e v o d . w . w ly /w n / o : tsp se th lu a m n fro rso d e ldeao rpoF PowerdbyTCPDF(ww.tcpdf.org) n a liu 6 Aims: To review the evidence for efficacy, safety, and cost-effectiveness of levodopa/carbidopa/ entacapone (LCE) compared with levodopa/dopa-decarboxyiase inhibitor (DDCI) for Parkinson's disease (PD). Chinese Sci-tech Journals Database and China National Knowledge Infrastructure, as well as ClinicalTrials.gov, were searched for randomized controlled trials with “levodopa/carbidopa/ entacapone” as keywords. The search period was from inception to August 2017. We conducted meta-analyses to synthesize the evidence quantitatively. Results: A total of 5,693 records were obtained. We included seven randomized controlled trials and one cost-effectiveness study after the screening process. Compared with levodopaDDCI, LCE improved patient Unified Parkinson's Disease Rating Scale (UPDRS) II score (mean difference [MD] -1.17, 95% CI -1.64 to -0.71), UPDRS III score (MD -1.55, 95% CI -2.29 to -0.81), and Schwab and England daily activity rating (MD 2.05, 95% CI 0.85-3.26). There was no statistically significant difference in the risk of serious adverse events (AEs) or discontinuation due to AEs in patients with LCE, and the risk of total AEs was higher in the LCE group (risk ratio [RR] 1.33, 95% CI 1.05-1.70). The incremental cost-effectiveness ratio of LCE was £3,105 per quality-adjusted life-year (QALY) gained in the UK. Conclusion: LCE can improve PD patients' motor symptoms and daily living functioning when compared with levodopa/DDCI. events, cost-effectiveness, health technology assessment Parkinson's disease (PD) is considered one of the commonest neurodegenerative diseases. Regarding pathophysiology, the primary cause of PD is the degeneration of dopamineproducing neurons in the substantia nigra and the formation of Lewy bodies. PD is usually suspected in patients presenting with bradykinesia, rigidity, tremors, and/or postural instability.1 Furthermore, the risk of PD increases nearly exponentially with age and peaks after 80 years of age.2 Globally, the estimation of incidence of PD is 10-18 per 100,000 person-years,2 which imposes a considerable disease burden on the patient, the family, and society as a whole, due to medication, hospitalization, and productivity loss. Unified Parkinson's Disease Rating Scale; quality of life; wearing off; adverse - open access to scientific and medical research Introduction dopamine replacement and dopamine agonists.3,4 Levodopa is the most efficacious treatment of PD, developed in the late 1960s; however, approximately 70% of oral levodopa is metabolized by aromatic amino-acid decarboxylase in the intestinal mucosa and liver.5 A dopa-decarboxylase inhibitor 8 (DDCI), such as carbidopa or benserazide, is then adminis-012 tered with levodopa to increase drastically the half-life and l-Ju concentration area under the curve of levodopa. Addition1n2 ally, another peripheral route of levodopa metabolism is via 07o catechol-O-methyltransferase (COMT). Finally, entacapone .624 is a peripheral, reversible COMT inhibitor that increases the ..95 half-life of levodopa to make more levodopa sustainable. y73 A series of clinical trials on PD patients suggested that /bm the addition of entacapone to levodopa/DDCI increased .cso the “on” time (when patients experience benefit from rsep levodopa) and meanwhile reduced the mean daily levodopa veo dose.6,7 Moreover, the combination therapy was supposed .dw . to be potentially cost-effective compared with levodopa //:ww lyno monotherapy.8 The combination product of levodopa/ tsp se carbidopa/entacapone (LCE) was approved by the US Food th lu m an and Drug Administration in 2003 and introduced to the frod rsoe Chinese market in 2013.5 However, no systematic review on ldeao rpoF its efficacy and safety has been conducted until now, and due nw to inconsistent evidence on its efficacy, safety, and economy tndo across end points, it has not been covered by medical insureem ance in China.9,1 (...truncated)


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Zhan-Miao Yi, Ting-Ting Qiu, Yuan Zhang, Na Liu, Suo-Di Zhai. Levodopa/carbidopa/entacapone versus levodopa/dopa-decarboxyiase inhibitor for the treatment of Parkinson's disease: systematic review, meta-analysis, and economic evaluation, Therapeutics and Clinical Risk Management, 2018, pp. 709-719, DOI: 10.2147/TCRM.S163190