Exosome analysis in patients with marked hypercholesterolemia or Lp(a) hypercholesterolemia receiving chronic lipoprotein apheresis or PCSK9 inhibitor therapy. - Ex(2)LAPH-Study

开始日期2023-07-12

申办/合作机构-

NCT05457582 / RecruitingN/AIIT

PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions.

开始日期2023-03-30

申办/合作机构

南京医科大学第一附属医院

[+2]

ACTRN12616000871448 / Suspended临床3期

Evaluating the efficacy and adherence of administration of a PCSK9 inhibitor Alirocumab in Aboriginal participants with hypercholesterolaemia

开始日期2017-12-20

申办/合作机构

South Australian Health & Medical Research Institute Ltd.

100 项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的临床结果

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100 项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的转化医学

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100 项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的专利（医药）

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项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的文献（医药）

2024-11-01·AMERICAN HEART JOURNAL

PCSK9 inhibitor added to high-intensity statin therapy to prevent cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention: a randomized, double- blind, placebo-controlled, multicenter SHAWN study

Article

作者: Wang, Xin ; Kan, Jing ; Ge, Zhen ; Lin, Song ; Ji, Hong-Lei ; Zhao, Shou-Ming ; Liu, Li-Jun ; Chen, Shao-Liang ; Wen, Shang-Yu ; Wu, Zhi-Ming ; Chen, Jing ; Zhou, Sheng-Hua ; Luo, Jun ; Li, Rui ; Zhang, Jun-Jie ; Xie, Ping ; Cong, Hong-Liang ; You, Wei ; Zheng, Yong-Hong ; Liu, Zhi-Zhong ; Zhou, Lei ; Wu, Xiang-Qi ; Bo Li, Xiao- ; Zeng, He-Song ; Qian, Xue-Song ; Gao, Xiao-Fei ; Liu, Fan ; Ye, Fei ; Tian, Nai-Liang ; Wang, Yan

BACKGROUND:

It is currently uncertain whether the combination of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and high-intensity statin treatment can effectively reduce cardiovascular events in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) for culprit lesions.

METHODS:

This study protocol describes a double-blind, randomized, placebo-controlled, multicenter study aiming to investigate the efficacy and safety of combining a PCSK9 inhibitor with high-intensity statin therapy in patients with ACS following PCI. A total of 1212 patients with ACS and multiple lesions will be enrolled and randomly assigned to receive either PCSK9 inhibitor plus high-intensity statin therapy or high-intensity statin monotherapy. The randomization process will be stratified by sites, diabetes, initial presentation and use of stable (≥4 weeks) statin treatment at presentation. PCSK 9 inhibitor or its placebo is injected within 4 hours after PCI for the culprit lesion. The primary endpoint is the composite of cardiovascular death, myocardial infarction, stroke, re-hospitalization due to ACS or heart failure, or any ischemia-driven coronary revascularization at one-year follow-up between two groups. Safety endpoints mean PCSK 9 inhibitor and statin intolerance.

CONCLUSION:

The SHAWN study has been specifically designed to evaluate the effectiveness and safety of adding a PCSK9 inhibitor to high-intensity statin therapy in patients who have experienced ACS following PCI. The primary objective of this study is to generate new evidence regarding the potential benefits of combining a PCSK9 inhibitor with high-intensity statin treatment in reducing cardiovascular events among these patients.

2024-10-01·JACC-Basic to Translational Science

PCSK9 Antibodies Treatment Specifically Enhances the Macrophage-specific Reverse Cholesterol Transport Pathway in Heterozygous Familial Hypercholesterolemia

Article

作者: Lee-Rueckert, Miriam ; Santos, David ; Gómez-Coronado, Diego ; Jauhiainen, Matti ; Masana, Luis ; Ribalta, Josep ; Kovanen, Petri T ; Blanco-Vaca, Francisco ; Escolà-Gil, Joan Carles ; Martínez-Botas, Javier ; Revilla, Giovanna ; Borràs, Carla ; Canyelles, Marina ; Girona, Josefa ; Rotllan, Noemí ; Llorente-Cortes, Vicenta ; Kovanen, Petri T. ; Tondo, Mireia ; Ibarretxe, Daiana ; Arrieta, Francisco

We investigated the potential of proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies to restore macrophage cholesterol efflux in subjects with heterozygous familial hypercholesterolemia (FH) and to enhance the macrophage-specific reverse cholesterol transport pathway in mice. Analyses of macrophage-derived cholesterol distribution of plasma from FH patients revealed that low-density lipoprotein (LDL) particles contained less, and high-density lipoprotein particles contained more radiolabeled cholesterol after treatment with either PCSK9 inhibitor. PCSK9 antibodies facilitated the transfer of macrophage-derived cholesterol and LDL-derived cholesterol to feces exclusively in heterozygous LDL receptor-deficient mice expressing human APOB100. PCSK9 inhibitors act as positive regulators of the macrophage-specific reverse cholesterol transport pathway in individuals with heterozygous FH.

2024-08-01·Alternative therapies in health and medicine

PCSK9 Inhibitors in Multi-Branch Lesions in Coronary Artery Disease with Substandard Lipid-Lowering Effects.

Article

作者: Lu, Wei ; Wang, Lijun ; Qin, Liqiang ; Du, Chao ; Li, Juan ; Wang, Hongchao

Objective:

This study was carried out to evaluate the clinical efficacy of proprotein convertase chymotrypsin 9 (PCSK9) inhibitors in multi-branch lesions in coronary artery disease with substandard lipid-lowering effects.

Methods:

This retrospective study collected the clinical data of 100 patients with multiple coronary artery diseases admitted to our hospital between May 2020 and August 2022 for analysis. The eligible patients were assigned to either a PCSK9 inhibitor group or a control group at a ratio of 1:1 by their dosing regimens, with 50 cases in each group. Outcome measures for the clinical efficacy of PCSK9 inhibitors included lipid levels, low-density lipoprotein cholesterol (LDL-C) changes, serum concentrations of coronary artery disease-related inflammatory factors, improvement of angina questionnaire scores, adverse reactions, and major cardiovascular adverse events.

Results:

PCSK9 inhibitors resulted in significantly lower serum concentrations of total cholesterol (TC), LDL-C, and ApoB and higher high-density lipoprotein cholesterol (HDL-C) levels versus conventional lipid-lowering medication (P < .05). The two arms exhibited similar serum concentrations of triglyceride (TG) and ApoA1 after treatment (P > .05). With LDL-C<1.4 mmol/L as the cut-off for desirable blood lipid levels, 47 (94%) patients reached the standard after in the PCSK9 inhibitors group, while no eligible cases were reported in the control group (P < .05). PCSK9 inhibitors provided a marked reduction in the serum concentrations of high-sensitivity C-reactive protein in the patients. Patients had higher angina stability (AS), angina flare (AF), physical limitation (PL), and treatment satisfaction (TS) scores after PCSK9 inhibitor administration versus after conventional medication (P < .05). PCSK9 inhibitors were associated with a significantly lower incidence of adverse cardiovascular events (10%) versus conventional medication (42%) (P < .05).

Conclusion:

PCSK9 inhibitors significantly improve the LDL-C concentrations of patients with multiple lesions of coronary artery disease who have failed to meet lipid-lowering targets, this enables physicians to more effectively manage patients' cholesterol levels, consequently reducing their cardiovascular risk. Moreover, these inhibitors have the potential to enhance patients' quality of life by alleviating relieve angina symptoms. These findings offer valuable insights into managing multi-branch coronary artery disease.

项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的新闻（医药）

2024-09-29

·医药笔记

君实生物：PCSK9抗体上市申请收到通知件

▎Armstrong 2024年9月29日，君实生物PCSK9抗体上市申请的两项受理号收到通知件，意味着未获得批准（可能是主动撤回或暂未批准等情况）。 2023年4月，君实生物PCSK9抗体上市申请4个受理号，此次获得通知件的为其中2个，另外2个尚无结果。 4个受理号涉及2个规格（预充式注射器、预充式自动注射器）和2个适应症。此次2个通知件意味着某个规格或某个适应症未获得批准。总结 PCSK9靶点的竞争尤为激烈，除了安进、赛诺菲的抗体，信达生物的PCSK9抗体、诺华的PCSK9 siRNA都已经获批上市，其中诺华的PCSK9 siRNA只需要每半年给药一次。对于该靶点，还有更多差异化产品在研发中，包括默沙东的PCSK9口服大环肽，礼来等的PCSK9体内基因编辑等。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

抗体药物偶联物

2024-08-31

·药事纵横

和元生物2024 H1：新增CDMO订单超2.1亿元

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2024年8月28日，诺华宣布在III期V-MONO研究中一年两次Leqvio（Inclisiran）取得了积极的初步结果，达到了主要终点。与安慰剂和依折麦布相比，Leqvio单药治疗对动脉粥样硬化性心血管疾病（ASCVD）中低风险且未接受降脂治疗的患者的低密度脂蛋白胆固醇（LDL-C）的降低具有临床意义和统计学意义。 V-MONO是首个评估小干扰RNA (siRNA) 疗法作为单一疗法降低ASCVD低风险或中等风险患者的LDL-C的试验。诺华计划在即将召开的医学会议上介绍这项试验的结果，并与包括美国FDA在内的监管机构分享。 Leqvio原本是由MDCO公司和Alnylam合作开发的。2019年，诺华以97亿美元收购MDCO公司（Alnylam授权）获得。Leqvio是一款first-in-class靶向PCSK9的siRNA药物，每年只需两次皮下给药，该药物是全球首款也是目前唯一一款PCSK9 siRNA降血脂药物。Leqvio在欧美的定价为6500美元/年，约4.7万元/年；国内定价9988元/针，约2万元/年。 Leqvio于2021年12月获FDA批准上市，适用于ASCVD患者和杂合子型家族性高胆固醇血症（HeFH）患者。2023年7月Leqvio的适应症扩大至原发性高脂血症患者的使用。Leqvio已在近100个国家获得批准，包括美国、欧盟、日本和中国。诺华公司开发总裁兼首席医疗官、医学博士Shreeram Aradhye说：“我们很自豪能继续推进对使用siRNA疗法的科学理解，以应对世界上最大的医疗挑战之一，因为太多的人仍在为达到胆固醇目标而挣扎。这项试验为Leqvio治疗各种ASCVD增加了更多的证据，我们将努力帮助更多需要帮助的患者。” 诺华将继续推进多项研究，评估Leqvio在一级和二级预防中的潜在用途。VICTORION-1-PREVENT (V1P) 是根据美国心脏病学会 (ACC) 和美国心脏协会 (AHA) 指南定义的高风险一级预防人群中唯一一项非他汀类降脂疗法的专门研究；这项结果研究预计将于今年晚些时候完成注册。在二级预防方面，ORION-4和 VICTORION-2-PREVENT (V2P) 结果研究仍在按计划进行，将分别于2026年和 2027年公布数据。总结 PCSK9是前蛋白转化酶家族中的第9个蛋白酶K亚家族，主要由肝脏合成的分泌型丝氨酸蛋白酶，可与肝细胞上低密度脂蛋白胆固醇受体( LDL-Ｒ) 结合并使LDL-Ｒ降解，从而减少LDL-R对血液中LDL-C的清除，升高LDL-C的水平。国内已批准上市的三款PCSK9抑制剂包括：PCSK9单抗依洛尤单抗（瑞百安，Evolocumab）和阿利西尤单抗（波立达，Alirocumab）以及一款PCSK9 siRNA英克司兰钠注射液（乐可为，Inclisiran）。目前，国内多家企业看好靶向PCSK9 siRNA药物的巨大市场及研发空间，并开发出多款在研药物：参考资料：公司公告

siRNA临床结果AHA会议临床3期上市批准

2024-08-30

·药融圈

3期临床成功！诺华PCSK9 siRNA计划拓展适应症

▲10月26-27日成都中国临床试验产业发展大会免费报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 2024年8月28日，诺华宣布在III期V-MONO研究中一年两次Leqvio（Inclisiran）取得了积极的初步结果，达到了主要终点。与安慰剂和依折麦布相比，Leqvio单药治疗对动脉粥样硬化性心血管疾病（ASCVD）中低风险且未接受降脂治疗的患者的低密度脂蛋白胆固醇（LDL-C）的降低具有临床意义和统计学意义。 V-MONO是首个评估小干扰RNA (siRNA) 疗法作为单一疗法降低ASCVD低风险或中等风险患者的LDL-C的试验。诺华计划在即将召开的医学会议上介绍这项试验的结果，并与包括美国FDA在内的监管机构分享。 Leqvio原本是由MDCO公司和Alnylam合作开发的。2019年，诺华以97亿美元收购MDCO公司（Alnylam授权）获得。Leqvio是一款first-in-class靶向PCSK9的siRNA药物，每年只需两次皮下给药，该药物是全球首款也是目前唯一一款PCSK9 siRNA降血脂药物。Leqvio在欧美的定价为6500美元/年，约4.7万元/年；国内定价9988元/针，约2万元/年。 Leqvio于2021年12月获FDA批准上市，适用于ASCVD患者和杂合子型家族性高胆固醇血症（HeFH）患者。2023年7月Leqvio的适应症扩大至原发性高脂血症患者的使用。Leqvio已在近100个国家获得批准，包括美国、欧盟、日本和中国。诺华公司开发总裁兼首席医疗官、医学博士Shreeram Aradhye说：“我们很自豪能继续推进对使用siRNA疗法的科学理解，以应对世界上最大的医疗挑战之一，因为太多的人仍在为达到胆固醇目标而挣扎。这项试验为Leqvio治疗各种ASCVD增加了更多的证据，我们将努力帮助更多需要帮助的患者。” 诺华将继续推进多项研究，评估Leqvio在一级和二级预防中的潜在用途。VICTORION-1-PREVENT (V1P) 是根据美国心脏病学会 (ACC) 和美国心脏协会 (AHA) 指南定义的高风险一级预防人群中唯一一项非他汀类降脂疗法的专门研究；这项结果研究预计将于今年晚些时候完成注册。在二级预防方面，ORION-4和 VICTORION-2-PREVENT (V2P) 结果研究仍在按计划进行，将分别于2026年和 2027年公布数据。总结 PCSK9是前蛋白转化酶家族中的第9个蛋白酶K亚家族，主要由肝脏合成的分泌型丝氨酸蛋白酶，可与肝细胞上低密度脂蛋白胆固醇受体( LDL-Ｒ) 结合并使LDL-Ｒ降解，从而减少LDL-R对血液中LDL-C的清除，升高LDL-C的水平。国内已批准上市的三款PCSK9抑制剂包括：PCSK9单抗依洛尤单抗（瑞百安，Evolocumab）和阿利西尤单抗（波立达，Alirocumab）以及一款PCSK9 siRNA英克司兰钠注射液（乐可为，Inclisiran）。目前，国内多家企业看好靶向PCSK9 siRNA药物的巨大市场及研发空间，并开发出多款在研药物：参考资料：公司公告版权声明：本文转自细胞基因治疗前沿，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

siRNAAHA会议临床结果临床3期

100 项与 PCSK9 inhibitor (CG Pharmaceuticals) 相关的药物交易

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