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      Clinical Evaluation Of Evolocumab For The Treatment Of Homozygous Familial Hypercholesterolemia In Chinese Patients

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          Abstract

          Evolocumab, which can lower low-density lipoprotein (LDL) cholesterol levels by approximately 60% and prevent cardiovascular events in patients with cardiovascular disease, is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Some studies have investigated its efficacy and safety in the treatment of the homozygous form of familial hypercholesterolemia (HoFH), and others have focused on its efficacy and safety in Asians with high cardiovascular risk. Although no direct evolocumab clinical trials have been conducted in Chinese HoFH patients, its efficacy and safety in the Chinese population should be similar to those in other ethnic groups.

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          Most cited references 14

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          Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia.

          Homozygous familial hypercholesterolemia is a rare, serious disorder with a substantial reduction in low-density lipoprotein (LDL) receptor function, severely elevated LDL cholesterol, cardiovascular disease, and often death in childhood. Response to conventional drug therapies is modest. Monoclonal antibodies to proprotein convertase subtilisin/kexin 9 (PCSK9) reduce LDL cholesterol in heterozygous familial hypercholesterolemia. The effect in homozygous familial hypercholesterolemia is unknown and uncertain. We evaluated the efficacy and safety of AMG 145 in an open-label, single-arm, multicenter, dose-scheduling pilot study in patients with homozygous familial hypercholesterolemia. Eight patients with LDL receptor-negative or -defective homozygous familial hypercholesterolemia on stable drug therapy were treated with subcutaneous 420 mg AMG 145 every 4 weeks for ≥12 weeks, followed by 420 mg AMG 145 every 2 weeks for an additional 12 weeks. All patients completed both treatment periods. Mean change from baseline in LDL cholesterol at week 12 was -16.5% (range, 5.2% to -43.6%; P=0.0781) and -13.9% (range, 39.9% to -43.3%; P=0.1484) with 4- and 2-week dosing, respectively. No reduction was seen in the 2 receptor-negative patients. Over the treatment periods, mean±SD LDL cholesterol reductions in the 6 LDL receptor-defective patients were 19.3±16% and 26.3±20% with 4- and 2-week dosing, respectively (P=0.0313 for both values), ranging from 4% to 48% with 2-week dosing. No serious side effects were reported. This study demonstrates significant and dose-related LDL cholesterol lowering with a PCSK9 monoclonal antibody in homozygous familial hypercholesterolemia patients with defective LDL receptor activity but no reduction in those who were receptor negative.
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            Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study.

            Homozygous familial hypercholesterolaemia is a genetic disorder characterised by substantially raised LDL cholesterol, reduced LDL receptor function, xanthomas, and cardiovascular disease before age 20 years. Conventional therapy is with statins, ezetimibe, and apheresis. We aimed to assess the long-term safety and efficacy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab in a subset of patients with homozygous familial hypercholesterolaemia enrolled in an open-label, non-randomised phase 3 trial.
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              Effects of evolocumab (AMG 145), a monoclonal antibody to PCSK9, in hypercholesterolemic, statin-treated Japanese patients at high cardiovascular risk--primary results from the phase 2 YUKAWA study.

              YUKAWA is a 12-week, randomized, double-blind, placebo-controlled, phase 2 study evaluating the efficacy and safety of evolocumab (AMG 145) in statin-treated Japanese patients at high cardiovascular risk.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                TCRM
                tcriskman
                Therapeutics and Clinical Risk Management
                Dove
                1176-6336
                1178-203X
                15 October 2019
                2019
                : 15
                : 1209-1216
                Affiliations
                [1 ]Department of Medical Education, Taipei Veterans General Hospital , Taipei, Taiwan
                [2 ]Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital , Taipei, Taiwan
                [3 ]Faculty of Medicine, School of Medicine, National Yang–Ming University , Taipei, Taiwan
                [4 ]Cardiovascular Research Center, National Yang-Ming University , Taipei, Taiwan
                [5 ]Institute of Pharmacology, National Yang-Ming University , Taipei, Taiwan
                Author notes
                Correspondence: Min-Ji Charng Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital , No. 201, Sec. 2, Shih-Pai Road, Taipei11217, Taiwan, R. O. C.Tel +886 2 28757507Fax +886 2 28756849 Email mjcharng@vghtpe.gov.tw
                Chin-Chou Huang Department of Medical Education, Taipei Veterans General hospital , No. 201, Sec. 2, Shih-Pai Road, Taipei11217, Taiwan, R. O. C.Tel +886 2 28757725Fax +886 2 28757726 Email cchuang4@vghtpe.gov.ytw
                Article
                193971
                10.2147/TCRM.S193971
                6800550
                © 2019 Huang and Charng.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Tables: 2, References: 24, Pages: 8
                Funding
                Funded by: Taiwan’s National Ministry of Science and Technology
                This work was funded by Taiwan’s National Ministry of Science and Technology (Grant number, MOST105-2314-B-075-040) and by Taipei Veterans General Hospital (Grant numbers, V105C-208 and V107C-078).
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