Autosomal dominant polycystic kidney disease (ADPKD), the most commonly inherited kidney disease, is characterized by the development of cysts in the kidney that impair function. Of those affected, half will progress to end-stage kidney disease by age 60, requiring dialysis or kidney transplant. To date, no effective and safe therapies exist for this deadly disease. Tolvaptan (Tol), the only FDA-approved drug for treatment of ADPKD, has some benefit in slowing kidney disease progression, but Tol causes frequent urination and thirst and also injures the liver in a small number of patients. The investigators' goal, therefore, is to develop new strategies to treat ADPKD that are safe and tolerable.
The development of cysts in ADPKD patients results from two main cellular processes. The first is cell growth with an increase in the number of kidney cells that make up the outer surface of the cyst. The second is an increase in fluid secretion into the cysts that develop. The investigators have shown that an enzyme, AMP-activated protein kinase (AMPK), when activated can inhibit both of those processes. Moreover, genetic mutations that cause ADPKD may alter the energy metabolism of the cell, which in turn inhibits AMPK activity. Bempedoic acid (BA), a medication that is FDA-approved for the treatment of individuals with high cholesterol and has a good safety record, activates AMPK. In addition to activating AMPK, BA inhibits a second enzyme called ATP-citrate lyase (ACLY), which is involved in cholesterol synthesis. ACLY has received growing attention as a novel target for cancer treatment. ACLY inhibition blocks increases of cell numbers by inhibiting the lipid synthesis that is required for creation of new cell membranes. This study will test whether targeting these pathways through treatment with BA will help reverse dysfunctional metabolism in individuals with ADPKD and slow disease progression.
The investigators will test this using a phase 2 clinical trial in which 120 individuals with rapidly progressive ADPKD and an estimated glomerular filtration rate of 35 or greater will be treated with either BA or placebo (inactive look-alike pill) for two years. Participants on or off a stable dose of Tol will be included in the study. Participants will be recruited from the U. of Vermont, U. of Maryland, and Tufts University, which have active PKD clinics and are recognized by the PKD Foundation as Centers of Excellence. Through follow-up visits and lab work, the investigators will assess the safety and tolerability of BA in the participants as the primary outcomes. The secondary goals are to assess preliminary efficacy and effects of BA on quality of life in study participants. The growth of cysts results in increased volume or size of the kidneys and liver. Total and cyst volumes of the kidney and liver and visceral abdominal fat content via magnetic resonance imaging (MRI) will be measured to gauge the effectiveness of this drug. The investigators also predict that proteins and small molecules involved in regulating cell energy metabolism, inflammation, and injury, as well as proteins directly involved in AMPK and ACLY function, will be altered in ADPKD patients. Levels of these proteins and small molecules may then subsequently change with BA therapy. Exploratory, mechanistic goals of this study are to identify prognostic and predictive urinary biomarkers in study participants. Successful completion of this study would have a significant impact on individuals with ADPKD by laying the groundwork for a new treatment strategy as well as by providing a new way to help guide treatment decisions.
In summary, the goals of this phase 2 randomized, double-blind, placebo-controlled clinical trial are to test the safety, tolerability and preliminary efficacy of the drug bempedoic acid, FDA-approved to lower cholesterol, when used in ADPKD patients.

开始日期2026-09-21

申办/合作机构

University of Vermont

[+5]

NCT07474649

/ Not yet recruiting临床3期

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

开始日期2026-07-31

申办/合作机构

Daiichi Sankyo Co., Ltd.

NCT07623915

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.

开始日期2026-06-12

申办/合作机构

石药集团欧意药业有限公司

100 项与贝派地酸相关的临床结果

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100 项与贝派地酸相关的转化医学

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100 项与贝派地酸相关的专利（医药）

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362

项与贝派地酸相关的文献（医药）

2026-12-31·RENAL FAILURE

Emerging roles of ATP citrate lyase in kidney diseases: from pathogenic driver to therapeutic target

Review

作者: Chen, Yinyin ; Yang, Yiya ; Tao, Mina ; Wei, Mengjiao ; Tan, Huifang ; Li, Guoli ; Jin, Zhiyuan ; Xiao, Zheng

ATP-citrate lyase (ACLY) is a crucial cytosolic and nuclear enzyme that catalyzes the synthesis of acetyl-CoA from citrate, serving as a central metabolic node linking carbohydrate metabolism to de novo lipogenesis and histone acetylation. Accumulating evidence positions ACLY not merely as a metabolic enzyme but as a key pathogenic driver in various kidney diseases. This review systematically examines the multifaceted roles of ACLY in renal physiology and pathology. During development, ACLY is essential for nephron progenitor cell maintenance and nephrogenesis. In diabetic kidney disease, hyperglycemia upregulates and promotes nuclear translocation of ACLY, fueling histone acetylation and the transcription of pro-fibrotic genes, while also contributing to oxidative stress and lipid peroxidation. In obesity-related kidney injury, ACLY drives renal ectopic lipid accumulation and inflammation by providing substrates for adipogenic enzymes and inducing histone hyperacetylation. ACLY also promotes renal fibrosis in chronic kidney disease via pathways such as AKT/ACLY signaling. In clear cell renal cell carcinoma, ACLY expression is upregulated through HIF-2α/LPCAT1/FBXW7 and VHL/PPARγ axes, promoting lipid synthesis, tumor proliferation, and metastasis. Furthermore, ACLY activity influences hypocitraturia, a key factor in nephrolithiasis, and is upregulated in polycystic kidney disease, where its inhibition attenuates cystic growth. Given its central role across diverse renal pathologies, ACLY emerges as a promising therapeutic target. Several inhibitors, including bempedoic acid, SB-204990, and natural compounds, show potential in modulating ACLY activity. This review consolidates current knowledge on ACLY in kidney diseases, highlighting its mechanistic contributions, and underscoring its significant potential for diagnostic and therapeutic innovation.

2026-09-01·Atherosclerosis plus

Systematic literature review on the real-world effectiveness and safety of bempedoic acid

Review

作者: Gautam, Raju ; Chhabra, Richa ; Anwar, Saeed ; Ghatak, Aishee ; Cannon, Christopher P ; Powell, Heather A ; Sarnes, Evelyn ; Cicero, Arrigo Francesco Giuseppe ; Jawla, Shantanu

Background and aims:

Cardiovascular disease remains a significant global health burden. Bempedoic acid is a novel, oral adenosine triphosphate-citrate lyase inhibitor that lowers low-density lipoprotein cholesterol (LDL-C). While randomized controlled trials (RCTs) have established its efficacy and safety, evidence from real-world clinical practice is needed.

Methods:

A systematic literature review (SLR) was conducted to identify studies reporting real-world use of bempedoic acid as monotherapy, in fixed dose combination with ezetimibe, or in combination with any other lipid lowering therapy (LLT). MEDLINE, EMBASE, and Cochrane Library were searched from inception to February 19, 2025. Two reviewers independently screened studies, with discrepancies resolved by a third. Data extraction and validation were conducted, and the risk of bias assessed using the Newcastle-Ottawa Scale.

Results:

Of 269 records, 28 reports on 22 unique studies met the eligibility criteria. Most studies evaluated LDL-C changes from baseline after initiation of bempedoic acid; one pragmatic randomized trial was identified. Bempedoic acid achieved LDL-C reductions of 15% to 39% when added to maximally tolerated statins, 22% to 38% in statin intolerant cohorts, and 18% to 42% in mixed statin intolerant cohorts. Safety data was limited; treatment discontinuation ranged from 9% to 36%, with higher rates in cohorts with greater statin-intolerance.

Discussion:

This SLR shows bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with RCTs. Data suggests it may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.

2026-07-01·CLINICAL MEDICINE

Lipid lowering in coronary artery disease – not just statins

Review

作者: Wang, Timothy ; Masmanian, Eva ; Chua, Tuan Peng ; Han, Jennie

Coronary artery disease has a high degree of morbidity and mortality internationally and, after a cardiovascular event, patients require intensified management of modifiable risk factors, with optimal lipid control being an important cornerstone of secondary prevention. This is both a primary and a secondary care responsibility. Familiarity with indications for and prescription of non-statin medications, including injectables, is vital for patient outcomes. Fewer than 30% of patients reach LDL-c targets with statins alone. This is a public health matter, and non-statin therapies that all clinicians need to be aware of are oral therapies such as ezetimibe and bempedoic acid, and injectable therapies such as inclisiran and PCKS9 inhibitors. Icosapent ethyl is also available in those with high fasting triglycerides with specific LDL-c values. Understanding when to refer to the lipid clinic enables patients to be managed appropriately in the correct setting. Future therapies under development include cholesterol ester transfer protein inhibitors, oral PCSK9 inhibitors, and gene editing therapy targeting ANGPTL3 and PCSK9. Lipid optimisation leads to significant reduction in major adverse cardiac events, and familiarity with all available treatment options - including non-statins and injectables - will facilitate best primary and secondary care.

375

项与贝派地酸相关的新闻（医药）

2026-07-31

·BioSpace

Daiichi Sankyo Reports First Quarter Fiscal Year 2026 Financial Results

Revenue increased 21.1% to 574.7 billion yen year-over-year driven by Enhertu ® and Datroway ® Fiscal year 2026 guidance for revenue and operating profit revised upward Conference call to take place on Friday, July 31 at 5:30 pm Japan Standard Time TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) reported financial results for the first quarter of fiscal year 2026, ending June 30, 2026. “Daiichi Sankyo delivered strong revenue growth in the first quarter of fiscal year 2026 as we began execution of our new Five-Year Business Plan,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “Three new U.S. approvals for Enhertu and Datroway were received in a single week in May, underscoring the continued strength of our portfolio where we anticipate delivering more than 20 new indications across five medicines by 2030. These results reinforce the durability of our growth trajectory and support our outlook for fiscal 2026 and beyond.” Q1 FY2026 Results Global revenue increased 21.1% year-over-year to 574.7 billion yen, driven by the company’s global oncology products. Operating profit decreased 12.0% year-over-year to 85.1 billion yen, primarily due to EU Specialty Business restructuring expenses. Global revenue from oncology products was driven by Enhertu ® and Datroway ® , the company's flagship antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 239.8 billion yen, a 48.9% increase. Datroway revenue, including milestone payments, was 23.9 billion yen, a 176.4% increase. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Revenue from the Japan Business was 120.0 billion yen, driven by Lixiana ® and Tarlige ® . ASCA (Asia, South and Central America) Business revenue was 68.7 billion yen, driven by Enhertu. EU Specialty Business revenue was 74.7 billion yen, driven by Lixiana and Nilemdo ® /Nustendi ® . Full fiscal year 2026 guidance has been revised upward from the forecast issued in May 2026. Global revenue is anticipated to increase from 2.28 to 2.34 trillion yen, driven by stronger sales anticipated in the U.S. and favorable foreign exchange rates. Operating profit is anticipated to increase from 315.0 to 320.0 billion yen. Further details on financial performance can be found in the Financial Results Presentation Material . Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q1 FY2026 results on Friday, July 31 at 5:30 pm Japan Standard Time. Q4 FY2025 Results Revision Operating profit has increased from 229.1 billion yen to 258.0 billion yen. Following the announcement of the Q4 FY2025 financial results on May 11, 2026, the Company identified an error in the aggregation process for selling, general and administrative (SG&A) expenses. As a result of the decrease in SG&A expenses, operating profit has been revised upward. Portfolio and Pipeline Highlights Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030. Three new breast cancer indications were approved within one week in the U.S. for Enhertu and Datroway in May 2026, including simultaneous approval of two new indications for Enhertu in the neoadjuvant and adjuvant HER2 positive early breast cancer setting based on the DESTINY-Breast11 and DESTINY-Breast05 phase 3 trials, followed by one new indication for Datroway in the first-line metastatic triple negative breast cancer (TNBC) setting for patients not candidates for immunotherapy based on the TROPION-Breast02 phase 3 trial. Datroway received approval in the EU for the same TNBC indication and Enhertu received a positive CHMP opinion for the first-line treatment of HER2 positive metastatic breast cancer based on the DESTINY-Breast09 phase 3 trial in July 2026. A Biologics License Application (BLA) was accepted and granted priority review in the U.S. in April 2026 for ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy, with a Prescription Drug User Fee Act (PDUFA) date of October 10, 2026. Additional regulatory approvals were received in June 2026 for medicines in other major countries/regions. Enhertu received approval in the EU for a HER2 positive metastatic tumor agnostic indication and Vanflyta ® was approved in China in the newly diagnosed setting of FLT3 -ITD positive acute myeloid leukemia (AML). Data from more than 25 abstracts across multiple cancers were presented at the 2026 American Society of Clinical Oncology (#ASCO26) in June 2026. Medicine Indication Q1 FY2026 Update Enhertu Breast Enhertu Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer ( May 2026 ) Enhertu Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer ( July 2026 ) Tumor Agnostic Enhertu Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors ( June 2026 ) Datroway Breast Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates ( May 2026 ) Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy ( July 2026 ) I-DXd Lung Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy ( April 2026 ) Vanflyta AML Vanflyta Approved in China as First and Only FLT3 Inhibitor for Patients with Newly Diagnosed FLT3 -ITD Positive AML ( June 2026 ) Pipeline Various Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO ( May 2026 ) Corporate Highlights Daiichi Sankyo announced its next Five-Year Business Plan (FY2026 - FY2030) in May 2026 outlining how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a “trusted healthcare innovator transforming the lives of people through our science and technology.” As part of the company’s continued transformation into a global oncology company, Daiichi Sankyo announced in April 2026 that it will transfer in stages all of its shares of Daiichi Sankyo Healthcare Co., Ltd, its over-the-counter drug business in Japan, to Suntory Holdings Limited. The deal is estimated to be completed by June 2029. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements, including words such as “anticipate,” “estimated,” “favorable,” “goal,” “momentum,” “outlook,” “trajectory,” were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from the outlook of Daiichi Sankyo or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantees that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof. The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain. This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com Japan: DS-PR_jp@daiichisankyo.com

上市批准免疫疗法临床3期ASCO会议财报

2026-07-30

·CVDAILY

全球血脂速递（第211期）｜他汀优化、药师主导、儿童脂蛋白、肥胖影响、糖尿病血脂、区域证据

*本资料仅供医疗卫生专业人士参考，请勿向非医疗卫生专业人士发放截至07月30日15点59分，近期共有 616 本期刊发布了 1405 篇文章，其中血脂相关的文章共 76 篇，覆盖 17 个领域的内容。中国专家参与发表的文章有 2 篇。今日，影响因子最高的文章刊登在 Nature genetics (IF: 29.000) 期刊上。今日头条 Headlines 01 GeroScience IF: 05.400 老年人他汀治疗优化：药师主导药学服务的随机对照试验中期结果 Anna Artner, Ágnes Szélvári, Ilona Oláh, Irén Ballya, Balázs Hankó, Romána Zelkó, etc. 一项发表在GeroScience上的随机对照试验中期分析评估了药师主导的药学服务对社区老年人血脂结局和他汀依从性的影响。研究纳入99例65岁及以上长期接受他汀治疗的患者，随机分配至常规护理组或每3个月接受一次结构化药师主导药学服务的干预组。主要终点为6个月时低密度脂蛋白胆固醇的变化，次要终点包括其他血脂参数和基于配药的依从性（用药天数比例）。结果显示，两组在低密度脂蛋白胆固醇降低方面无统计学显著差异（调整后差异-0.129 mmol/L，p=0.385）。他汀依从性在两组中均保持高水平且稳定，84-87%的患者达到依从性阈值，约75-77%实现完全配药，提示存在天花板效应。探索性性别分层分析发现血脂反应可能存在差异，但未达到统计学稳健性。研究结论指出，在这些基线依从性高的老年人群中，药师主导的药学服务并未带来额外的短期低密度脂蛋白胆固醇或依从性改善。该发现强调了在评估针对老年人的依从性干预措施时，考虑基线依从水平的重要性。本文由郑思思编辑扫描二维码查看源文 GeroScience | Ahead of Print. 10.1007/s11357-026-02445-y 02 Biomolecules IF: 04.800 超重/肥胖儿童与正常体重儿童不同脂蛋白的组成与特征 Jose Cuenca-Alcocel, Lorena Villalba-Heredia, Daiana Ibarretxe, Jose A Casajús, Jose M Arbonés-Mainar, Pilar Calmarza, etc. 儿童超重和肥胖在全球范围内日益严重，已成为重大公共卫生问题。在西班牙，儿童超重和肥胖的患病率居高不下，不同地区存在差异。最新发表在Biomolecules上的一项研究旨在通过先进的脂蛋白分析技术，比较超重/肥胖儿童与正常体重儿童在脂蛋白亚类、颗粒大小、颗粒数量和脂质组成方面的差异。研究纳入58例超重/肥胖儿童（根据IOTF标准）和45名正常体重儿童，年龄8-12岁，均处于青春期前。采用Liposcale®测试（基于1H-NMR技术）对脂蛋白颗粒进行详细分析。结果显示，超重/肥胖儿童组中，极低密度脂蛋白胆固醇、极低密度脂蛋白甘油三酯、中间密度脂蛋白甘油三酯和高密度脂蛋白甘油三酯的浓度显著高于正常体重组。同时，极低密度脂蛋白颗粒总数及其所有亚类（大、中、小）的数量也显著增加。相反，正常体重儿童的低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白颗粒（总和中、小亚类）以及高密度脂蛋白颗粒（总和小亚类）浓度更高。在颗粒大小方面，超重/肥胖儿童的低密度脂蛋白平均粒径显著小于正常体重儿童。此外，残余胆固醇和甘油三酯/高密度脂蛋白胆固醇比值在超重/肥胖组中显著升高。多变量回归分析显示，体重指数Z评分与大多数脂蛋白参数显著相关，而年龄和性别的影响较小。这些结果表明，超重/肥胖儿童在青春期前就已出现早期代谢异常，表现为更致动脉粥样硬化的脂蛋白谱。先进脂蛋白分析能够提供传统血脂谱之外的额外信息，有助于更准确地评估心血管风险。研究建议，应通过均衡饮食、限制简单糖和饱和脂肪摄入、增加体力活动以及减少腹围等措施，改善这些儿童当前和未来的心血管健康。本文由郑思思编辑扫描二维码查看源文 Biomolecules | Volume 16, Issue 7 10.3390/biom16070927 03 Frontiers in medicine IF: 03.000 2型糖尿病诊断时糖化血红蛋白与血脂参数的关系：来自区域人群的证据 Raquel Sainz-Prado, Beatriz Rodríguez-Roca, Miren Idoia Pardavila-Belio, Paula Rojas-García, Félix Rivera-Sanz, Elena Andrade-Gómez, etc. 一项发表在《Frontiers in Medicine》上的回顾性横断面研究，基于西班牙拉里奥哈地区2019年至2025年间新诊断的3501例2型糖尿病患者的电子健康记录数据，分析了诊断时糖化血红蛋白与血脂参数的关系。研究结果显示，在校正年龄、性别和体重指数后，糖化血红蛋白与总胆固醇（β=4.25, p<0.001）和甘油三酯（β=15.65, p<0.001）呈显著正相关，与高密度脂蛋白胆固醇呈显著负相关（β=-1.40, p<0.001）。但糖化血红蛋白与低密度脂蛋白胆固醇的关联未达到统计学意义（β=1.67, p=0.080）。患者平均年龄67.9岁，男性占56.2%。在糖化血红蛋白≥7%的患者中，甘油三酯水平显著升高。研究指出，即使在疾病早期，血糖控制不佳也与更致动脉粥样硬化的血脂谱相关，提示临床应重视新诊断患者的综合心血管风险评估。本文由郑思思编辑扫描二维码查看源文 Frontiers in medicine | Volume 13, Issue 10.3389/fmed.2026.1833588 中国发表（2） China JCTS IF: 01.500Ahead of Print.No.01Application of multi-omics analysis in atherosclerosis多组学分析在动脉粥样硬化中的应用DOI: 10.1186/s13019-026-04648-y Cardiovascular Toxicology IF: 03.700Volume 26, Issue 8, Page 82- 82No.02The ApoE-Null Golden Hamster: A Novel Model of AtherosclerosisApoE基因敲除金仓鼠：一种新型动脉粥样硬化模型DOI: 10.1007/s12012-026-10164-1 其他发布内容（71） More Published Articles Journal of ultrasound IF: 01.400Ahead of Print.No.01Incremental value of ultrasound-based carotid plaque-RADS beyond stenosis degree in discriminating symptomatic carotid atherosclerosis基于超声的颈动脉斑块RADS在狭窄程度之外鉴别症状性颈动脉粥样硬化的增量价值DOI: 10.1007/s40477-026-01197-x SoinsVolume 71, Issue 907No.02[Care for a patient who has undergone a vascular amputation]血管截肢患者的护理DOI: 10.1016/j.soin.2026.06.012 Autoimmunity reviews IF: 08.300Ahead of Print.No.03Effects of statin therapy on atherosclerosis progression, inflammation and lipid profiles in patients with systemic lupus erythematosus: A systematic review and meta-analysis of randomized controlled trials他汀类药物治疗对系统性红斑狼疮患者动脉粥样硬化进展、炎症和血脂谱的影响：随机对照试验的系统评价和荟萃分析DOI: 10.1016/j.autrev.2026.104153 Angiology IF: 02.200Ahead of Print.No.04Exploring the Potential Role of SLC25A25-AS1 in Acute Coronary Syndrome探索SLC25A25-AS1在急性冠脉综合征中的潜在作用DOI: 10.1177/00033197261471988 Cerebrovascular Diseases. Extra IF: 02.100Ahead of Print.No.05Dual Antiplatelet Therapy and Very Early Neurological Deterioration After Non-cardioembolic Stroke According to Stroke Etiology双联抗血小板治疗与非心源性栓塞性卒中后极早期神经功能恶化：基于卒中病因的分析DOI: 10.1159/000552952 Comput Methods Biomech Biomed Engin IF: 01.600Ahead of Print.No.06A preliminary study of an interpretable ensemble learning framework for atherosclerosis detection: algorithm development and exploratory feature analysis可解释集成学习框架用于动脉粥样硬化检测的初步研究：算法开发与探索性特征分析DOI: 10.1080/10255842.2026.2708886 Nature genetics IF: 29.000Ahead of Print.No.07Translating genomic data into healthcare practice with the Singapore National Precision Medicine program新加坡国家精准医学计划将基因组数据转化为医疗实践DOI: 10.1038/s41588-026-02687-8 Heart & Lung IF: 02.600Ahead of Print.No.08Detection rate and risk factors of carotid atherosclerotic plaque in patients with obstructive sleep apnea syndrome: A systematic review and meta-analysis阻塞性睡眠呼吸暂停综合征患者颈动脉粥样硬化斑块的检出率及危险因素：系统评价与荟萃分析DOI: 10.1016/j.hrtlng.2026.102902 Int J Med Sci IF: 03.200Volume 23, Issue 8No.09Risk of Peripheral Artery Disease and Venous Thromboembolism in Patients with Neuromyelitis Optic Spectrum Disorder: A Nationwide Population-Based Cohort Study视神经脊髓炎谱系疾病患者外周动脉疾病和静脉血栓栓塞风险：一项全国性人群队列研究DOI: 10.7150/ijms.130836 Naunyn Schmiedebergs Arch Pharmacol IF: 03.100Ahead of Print.No.10Transition to generic dolutegravir: immunologic, virologic, and metabolic outcomes in a resource-limited setting转换为仿制多替拉韦：资源有限环境下的免疫学、病毒学和代谢结局DOI: 10.1007/s00210-026-05766-z Journal of fish biology IF: 02.000Ahead of Print.No.11Integrated digestive and metabolic traits underlie trophic differentiation in juvenile fish assemblages消化与代谢特征整合驱动幼鱼群落的营养分化DOI: 10.1111/jfb.70594 Zhonghua erke zazhiVolume 64, Issue 8No.12[Construction of a risk prediction model for vascular function damage in children with primary hypertension]原发性高血压儿童血管功能损伤风险预测模型的构建DOI: 10.3760/cma.j.cn112140-20251119-01039 Food and chemical toxicology IF: 03.500Ahead of Print.No.13Perinatal exposure to polystyrene microplastics: biometric, hormonal and behavioral parameters of male and female Wistar rats at weaning, puberty and adulthood围产期暴露于聚苯乙烯微塑料：断奶期、青春期和成年期雄性和雌性Wistar大鼠的生物特征、激素和行为参数DOI: 10.1016/j.fct.2026.116305 Journal of critical care IF: 02.900Ahead of Print.No.14Immune cell death in sepsis: Linking resilience, dysbiosis, and EGFR signaling脓毒症中的免疫细胞死亡：连接恢复力、菌群失调与EGFR信号DOI: 10.1016/j.jcrc.2026.155698 Animal IF: 04.200Ahead of Print.No.15Effect of essential oil supplementation on growth and health in preweaning dairy calves: a meta-analysis精油补充对断奶前犊牛生长和健康影响的荟萃分析DOI: 10.1016/j.animal.2026.101892 Veterinary medicine and science IF: 01.700Volume 12, Issue 5No.16Effects of Prenatal Ursodeoxycholic Acid and Probiotic Supplementation on Stress Parameters, Immune Response and Lamb Survival Rates in Ewes产前熊去氧胆酸和益生菌补充对母羊应激参数、免疫反应和羔羊存活率的影响DOI: 10.1002/vms3.70859 Am J Case Rep IF: 01.000Volume 27, Issue No.17Coronary Artery Embolism From Atrial Flutter Presenting as Cardiac Arrest and ST-Elevation Myocardial Infarction: Diagnostic and Therapeutic Challenges心房扑动致冠状动脉栓塞表现为心脏骤停和ST段抬高型心肌梗死：诊断与治疗挑战DOI: 10.12659/AJCR.952062 South Dakota journal of medicineVolume 79, Issue suppl 5No.18Abstract: Expanding Access to Vascular Care Using BlueDop Vascular Expert: A Prospective Cohort Study使用BlueDop血管专家扩大血管护理的可及性：一项前瞻性队列研究https://pubmed.ncbi.nlm.nih.gov/42526018 JMIR formative research IF: 02.100Volume 10, Issue No.19Evaluating the Impact and Practicality of a National Digital Intervention for Type 2 Diabetes Mellitus: Single-Arm Nonrandomized Pilot Trial评估全国性2型糖尿病数字干预的影响和实用性：单臂非随机试点试验DOI: 10.2196/94551 JCTS IF: 01.500Ahead of Print.No.20Cerebrovascular stenosis and mortality after isolated off-pump coronary artery bypass grafting孤立性非体外循环冠状动脉旁路移植术后脑血管狭窄与死亡率的关系DOI: 10.1186/s13019-026-04664-y Eur J Gastroenterol Hepatol IF: 01.800Ahead of Print.No.21Development of a machine learning-based noninvasive diagnostic model for liver fibrosis in metabolic-associated steatotic liver disease基于机器学习的代谢相关脂肪性肝病肝纤维化无创诊断模型的开发DOI: 10.1097/MEG.0000000000003206 Ther Apher Dial IF: 01.200Ahead of Print.No.22Factors Associated With Dietary Attitudes in Hemodialysis Patients: A Mixed-Methods Study血液透析患者饮食态度相关因素：一项混合方法研究DOI: 10.1002/1744-9987.70203 Research squareVolume 0, Issue No.23Perturbed Inflammatory, Proliferation, Regulatory, And Neurodegeneration Signaling Pathways Are Associated With Trait Anxiety In Cancer Survivors癌症幸存者中与特质焦虑相关的炎症、增殖、调节和神经退行性信号通路扰动DOI: 10.21203/rs.3.rs-9383360/v1 Curēus IF: 01.300Volume 18, Issue 6No.24Workplace Environment and Lifestyle Factors Associated With Hyperuricemia Risk Among Male Manufacturing Workers: A Cross-Sectional Study at a Single Company in Japan日本某制造企业男性工人高尿酸血症风险相关的工作环境与生活方式因素：一项单公司横断面研究DOI: 10.7759/cureus.111627 Frontiers in endocrinology IF: 04.600Volume 17, Issue No.25Tuber intake is independently associated with reduced risk of Hashimoto's thyroiditis: a community-based cross-sectional study块茎类食物摄入与桥本甲状腺炎风险降低独立相关：一项社区横断面研究DOI: 10.3389/fendo.2026.1890093 Research squareVolume 0, Issue No.26Workplace Interventions to Improve Physical Activity, Reduce Sedentary Behavior, and Promote Healthy Diet Among Employees in Low- and Middle- Income Countries: A Systematic Review中低收入国家员工体力活动改善、久坐行为减少及健康饮食促进的工作场所干预：一项系统综述DOI: 10.21203/rs.3.rs-9730653/v1 EJPC IF: 07.500Ahead of Print.No.27Global Trends in Key Modifiable Cardiovascular Risk Factors: A Joinpoint Analysis Across WHO Regions (1990-2022)全球主要可改变心血管危险因素趋势：世界卫生组织区域的连接点分析（1990-2022）DOI: 10.1093/eurjpc/zwag401 bioRxivVolume 0, Issue No.28Site-specific cholesterol depletion therapy for gastric cancer胃癌位点特异性胆固醇耗竭疗法DOI: 10.64898/2026.07.15.738777 bioRxivVolume 0, Issue No.29Absolute quantitative proteomics guides patient-stratified drug repurposing in clear cell and papillary renal cell carcinoma绝对定量蛋白质组学指导透明细胞和乳头状肾细胞癌的患者分层药物再利用DOI: 10.64898/2026.07.17.738718 Expert Opin Biol Ther IF: 04.000Ahead of Print.No.30Twelve-month changes in lipid-derived cardiovascular risk indices among patients with psoriasis receiving biologic therapy: a multicenter real-world retrospective cohort study银屑病患者接受生物制剂治疗12个月后脂源性心血管风险指标的变化：一项多中心真实世界回顾性队列研究DOI: 10.1080/14712598.2026.2712432 CNS neuroscience & therapeutics IF: 05.000Volume 32, Issue 8No.31Prediction Model for Mild Cognitive Impairment in Older Chinese Patients With Cerebral Small Vessel Disease Based on XGBoost Algorithms and Shapley Additive Explanations基于XGBoost算法和Shapley加法解释的中国老年脑小血管病患者轻度认知障碍预测模型DOI: 10.1002/cns.71044 Health science reports IF: 02.100Volume 9, Issue 8No.32Associations of C-Reactive Protein-Triglyceride Glucose Index and Estimated Pulse Wave Velocity With All-Cause Mortality: A Nationwide Prospective Cohort StudyC反应蛋白-甘油三酯葡萄糖指数与估算脉搏波传导速度与全因死亡率的关联：一项全国性前瞻性队列研究DOI: 10.1002/hsr2.72870 BioTechnologiaVolume 107, Issue 2No.33Acne vaccine targeting Cutibacterium acnes secretory lipase suppresses the bacteria-induced pro-inflammatory interleukin-6 and macrophage inflammatory protein-2 production靶向痤疮皮肤杆菌分泌性脂肪酶的痤疮疫苗抑制细菌诱导的促炎性白细胞介素-6和巨噬细胞炎性蛋白-2的产生DOI: 10.5114/bta/221530 Reproduction IF: 03.700Ahead of Print.No.34AI-derived oocyte morphology and follicular fluid biomarkers in donors供卵者中AI衍生的卵母细胞形态与卵泡液生物标志物DOI: 10.1093/reprod/xaag092 Small IF: 12.100Ahead of Print.No.35Reverse-Engineered Lipid Nanoparticles Harness Protein Corona Formation for Cytokine Sequestration and Combination Immunomodulatory Therapy逆向工程脂质纳米颗粒利用蛋白冠形成实现细胞因子捕获与联合免疫调节治疗DOI: 10.1002/smll.74914 BJR|open IF: 02.100Volume 8, Issue 1No.36Imaging-based detection and prediction of radiation-induced cardiac toxicity: a narrative review基于影像的放射性心脏毒性检测与预测：叙述性综述DOI: 10.1093/bjro/tzag008 Int J Biol Sci IF: 10.000Volume 22, Issue 12No.37High density-lipoprotein regulates liquid-liquid phase separation of heat shock protein β-1 by lncRNA HDRACA to affect vascular inflammation and atherosclerosis高密度脂蛋白通过长链非编码RNA HDRACA调控热休克蛋白β-1的液-液相分离影响血管炎症和动脉粥样硬化DOI: 10.7150/ijbs.135145 Acta Cardiologica Sinica IF: 01.800Volume 42, Issue 4No.38Bortezomib Suppresses Abnormal Proliferation, Migration, and Phenotypic Switching of Aortic Smooth Muscle Cells硼替佐米抑制主动脉平滑肌细胞的异常增殖、迁移和表型转换DOI: 10.6515/ACS.202607_42(4).20251121A Journal of sleep research IF: 03.900Ahead of Print.No.39The Relative Contributions of Arousal Presence and Arousal Intensity to Post-Respiratory-Event Ventilation in Obstructive Sleep Apnea阻塞性睡眠呼吸暂停中觉醒存在和觉醒强度对呼吸事件后通气的相对贡献DOI: 10.1111/jsr.70412 Journal of cellular biochemistry IF: 02.800Volume 127, Issue 8No.40Notoginsenoside R1 Alleviates Macrophage Inflammatory Responses via Modulating the JAK1/STAT3 Pathway三七皂苷R1通过调节JAK1/STAT3通路减轻巨噬细胞炎症反应DOI: 10.1002/jcb.70112 Frontiers in pharmacology IF: 04.800Volume 17, Issue No.41Descriptive analysis of prescription interception patterns: characterizing medication safety risks in an outpatient setting处方拦截模式的描述性分析：门诊环境中用药安全风险的特征描述DOI: 10.3389/fphar.2026.1826012 Research squareVolume 0, Issue No.42Reduced LACTB expression in myeloid cells is associated with elevated succinylcarnitine and reduced Alzheimer's disease risk髓系细胞中LACTB表达降低与琥珀酰肉碱升高及阿尔茨海默病风险降低相关DOI: 10.21203/rs.3.rs-10216155/v1 AIDS and behavior IF: 02.400Ahead of Print.No.43Physician Education and Peer Comparisons to Reduce Cardiovascular Risk Among People Living with HIV: A Stepped-Wedge Cluster Randomized Trial医生教育与同行比较对降低HIV感染者心血管风险的影响：一项阶梯楔形整群随机试验DOI: 10.1007/s10461-026-05243-x Osteoporosis international IF: 05.400Ahead of Print.No.44Author response to OSIN-D-26-01484: "Clarifying statistical methods in a TriNetX analysis of statins and osteoporosis in CKD patients"作者对OSIN-D-26-01484的回复："阐明他汀类药物与CKD患者骨质疏松症TriNetX分析中的统计方法"DOI: 10.1007/s00198-026-08167-3 Osteoporosis international IF: 05.400Ahead of Print.No.45Clarifying statistical methods in a TriNetX analysis of statins and osteoporosis in CKD patientsTriNetX分析中他汀类药物与CKD患者骨质疏松关系的统计方法澄清DOI: 10.1007/s00198-026-08166-4 JACC IF: 22.300Ahead of Print.No.46Cross-Ancestry Proteogenomic Analyses Identified New Therapeutic Insights for Ischemic Heart Disease跨祖先蛋白质基因组分析为缺血性心脏病提供新的治疗见解DOI: 10.1016/j.jacc.2026.05.049 JACC IF: 22.300Ahead of Print.No.47Preventive Cardiovascular Care Delivery and Medicaid Accountable Care Organizations: A Difference-in-Differences Analysis预防性心血管护理服务与医疗补助责任医疗组织：一项双重差分分析DOI: 10.1016/j.jacc.2026.06.021 J Diabetes Metab Disord IF: 01.600Volume 25, Issue 2No.48Statin Use Patterns among hypertensive Patients in a population-based study基于人群的高血压患者他汀类药物使用模式研究DOI: 10.1007/s40200-026-02018-y EJPC IF: 07.500Ahead of Print.No.49Long-term exposure to bushfire-related fine particulate matter and coronary plaque burden in asymptomatic adults长期暴露于丛林火灾相关细颗粒物与无症状成人冠状动脉斑块负荷的关系DOI: 10.1093/eurjpc/zwag399 Einstein IF: 01.100Volume 24, Issue No.50Telecardiology assessment of patients undergoing non-cardiac surgery非心脏手术患者的远程心脏病学评估DOI: 10.31744/einstein_journal/2026AO1949 GeroScience IF: 05.400Ahead of Print.No.51Longitudinal association between dietary quality trajectories and cognitive frailty in older adults: a 12-year study of the TIGER cohort老年人膳食质量轨迹与认知衰弱的前瞻性关联：TIGER队列12年研究DOI: 10.1007/s11357-026-02413-6 Arquivos de gastroenterologiaVolume 63, Issue No.52USE OF THE FIBROSIS-4 INDEX FOR SCREENING LIVER FIBROSIS IN PEOPLE LIVING WITH HUMAN IMMUNODEFICIENCY VIRUS AND GLUCOSE METABOLISM DISORDERS纤维化-4指数在人类免疫缺陷病毒感染合并糖代谢异常患者中筛查肝纤维化的应用DOI: 10.1590/S0004-2803.24612026-003 Acta Cardiologica Sinica IF: 01.800Volume 42, Issue 4No.53PCSK9 Inhibitor Attenuates Platelet TLR4 in ACS and TLR4 Blockers Prevent PCSK9-Mediated Platelet ActivationPCSK9抑制剂减弱ACS患者血小板TLR4表达，TLR4阻断剂阻止PCSK9介导的血小板活化DOI: 10.6515/ACS.202607_42(4).20260126A Frontiers in public health IF: 03.400Volume 14, Issue No.54Burden of metabolic diseases in mainland China from 1990 to 2021: results from the global burden of disease study 20211990年至2021年中国大陆代谢性疾病负担：基于2021年全球疾病负担研究的结果DOI: 10.3389/fpubh.2026.1846594 Asian Pac J Cancer PrevVolume 27, Issue 7No.55The Synergistic Effects of Metformin with Pitavstatin Against MDA-MB-468 Breast Cancer Cells二甲双胍与匹伐他汀联合对MDA-MB-468乳腺癌细胞的协同作用DOI: 10.31557/APJCP.2026.27.7.2705 J Clin Biochem Nutr IF: 01.700Volume 79, Issue 1No.56Trace elements in relation to glycemic control and disease complications in children living with type 1 diabetes mellitus微量元素与1型糖尿病儿童血糖控制和并发症的关系DOI: 10.3164/jcbn.26-3 Ophthalmology retina IF: 05.700Ahead of Print.No.57Sustained High-Intensity Lipophilic Statin Use and Risk of Age-Related Macular Degeneration: A Target Trial Emulation持续高强度亲脂性他汀类药物使用与年龄相关性黄斑变性风险：一项目标试验模拟研究DOI: 10.1016/j.oret.2026.07.014 Annals of Vascular Surgery IF: 01.600Ahead of Print.No.58Uric Acid-to-High-Density Lipoprotein Cholesterol Ratio and Peripheral Arterial Disease: A Cross-Sectional Study from the National Health and Nutrition Examination Survey 1999-2004尿酸与高密度脂蛋白胆固醇比值与外周动脉疾病：来自1999-2004年美国国家健康与营养调查的横断面研究DOI: 10.1016/j.avsg.2026.07.032 Microcirculation IF: 02.000Volume 33microcirculation, Issue 6, Page e70066-e70080No.59Plantar Foot Microvascular Reactivity and Oxygenation in Type 2 Diabetes and Peripheral Artery Disease: An Exploratory Study2型糖尿病和外周动脉疾病患者足底微血管反应性与氧合：一项探索性研究DOI: 10.1111/micc.70078 PloS one IF: 02.600Volume 21, Issue 7No.60The effect of a multimodal multicomponent Prehabilitation program in Older adults with Chronic limb-threatening Ischemia (POCI-study): A study protocol for a multicenter randomized controlled trial多模式多组分预康复计划对老年慢性肢体威胁性缺血患者的效果（POCI研究）：一项多中心随机对照试验的研究方案DOI: 10.1371/journal.pone.0354344 Int J Geriatr Psychiatry IF: 02.800Volume 41, Issue 8No.61Dementia Risk With Combined Statin and Antihypertensive Drugs That Increase Versus Decrease Angiotensin-II Formation: Findings From the 45 and Up Study联合使用他汀与增加或减少血管紧张素II形成的降压药对痴呆风险的影响：来自45 and Up研究的结果DOI: 10.1002/gps.70243 Clinical Cardiology IF: 02.300Volume 49, Issue 8No.62Dynamic Co-Evolution of Obesity-Metabolic-Inflammatory for Cardiovascular Disease Risk Stratification in Middle-Aged and Older Adults: A Data-Driven Joint Trajectory Analysis肥胖-代谢-炎症动态共演化对中老年人心血管疾病风险分层：一项数据驱动的联合轨迹分析DOI: 10.1002/clc.70429 Development IF: 03.600Ahead of Print.No.63ATGL-mediated lipid droplet lipolysis promotes collective migration in DrosophilaATGL介导的脂滴脂解促进果蝇集体迁移DOI: 10.1242/dev.205486 Renal failure IF: 03.000Volume 48, Issue 1No.64Association between estimated glucose disposal rate and nephrolithiasis: a propensity score matching study in US adults: results from the National Health and Nutrition Examination Survey 2011-2020估计葡萄糖利用率与肾结石的关联：一项基于美国成年人的倾向评分匹配研究——2011-2020年国家健康与营养调查结果DOI: 10.1080/0886022X.2026.2684346 Chemical biology & drug design IF: 03.300Volume 108, Issue 2No.65Jiuwei Xiaozhi Decoction Alleviates High-Fat Diet-Induced MASLD by Suppressing Hepatic SREBP2-Driven Cholesterogenesis and Restoring PPARα-Mediated Fatty Acid Oxidation九味消脂汤通过抑制肝脏SREBP2驱动的胆固醇生成和恢复PPARα介导的脂肪酸氧化减轻高脂饮食诱导的代谢功能障碍相关脂肪性肝病DOI: 10.1111/cbdd.70371 Shengwu gongcheng xuebaoVolume 42, Issue 7No.66[Influences of hydroxylated recombinant human type III collagen on the functional characteristics of vascular smooth muscle cells]羟基化重组人III型胶原对血管平滑肌细胞功能特性的影响DOI: 10.13345/j.cjb.250718 Circulation Research IF: 16.200Ahead of Print.No.67Soluble TREM2 Drives Atherosclerosis via HSP90β-Dependent Myeloid Inflammation可溶性TREM2通过HSP90β依赖性髓系炎症驱动动脉粥样硬化DOI: 10.1161/CIRCRESAHA.125.327491 Acta Obstet Gynecol Scand IF: 03.100Ahead of Print.No.68Angiogenic biomarker concentrations and their relation to coronary atherosclerosis in women with a history of preeclampsia: Findings from the CPH-PRECIOUS study有先兆子痫病史女性血管生成生物标志物浓度及其与冠状动脉粥样硬化的关系：CPH-PRECIOUS研究结果DOI: 10.1111/aogs.70322 J Med Imaging Radiat Oncol IF: 01.400Ahead of Print.No.69Vertebral Bone Mineral Density Measured on Coronary CT Angiography as a Marker of Coronary Artery Disease Severity冠状动脉CT血管成像测量的椎体骨密度作为冠状动脉疾病严重程度的标志物DOI: 10.1111/1754-9485.70157 Biophysical journal IF: 03.100Ahead of Print.No.70Mechanosensitive ion channels in immunity from biophysics to mechanomedicine免疫中的机械敏感离子通道：从生物物理到机械医学DOI: 10.1016/j.bpj.2026.07.024 Angiology IF: 02.200Ahead of Print.No.71Bilateral Anterior Tragal Crease Is Associated With Coronary Revascularization in Patients With Stable Angina Pectoris双侧耳屏前皱褶与稳定型心绞痛患者冠状动脉血运重建的相关性DOI: 10.1177/00033197261474644 27 Atherosclerosis(AS) 动脉粥样硬化 24 Triglycerides(TG) 甘油三酯 14 Statins 他汀 13 Total Cholesterol(TC) 总胆固醇 5 Hyperlipidemias 高脂血症 3 Atorvastatin 阿托伐他汀 2 Dyslipidemias 血脂异常 2 Simvastatin 辛伐他汀 2 Hypercholesterolemia 高胆固醇血症 1 Evolocumab 依洛尤单抗 1 Ezetimibe 依折麦布 1 Bempedoic acid Bempedoic acid 1 Mipomersen 米泊美生 1 Lipoprotein(a)(Lp(a)) 脂蛋白a 1 PCSK9 Inhibitors(PCSK9i) 前蛋白转化酶枯草溶菌素9抑制剂 1 Rosuvastatin 瑞舒伐他汀 1 Pitavastatin 匹伐他汀编辑：郑思思审校：郑思思

2026-07-30

·云雀医站

全球首款口服PCSK9抑制剂获批！降脂进入口服时代

2026年7月16日，美国FDA正式批准默沙东（Merck）研发的Enlicitide上市，作为饮食控制和运动的辅助疗法，用于降低成人高胆固醇血症（包括杂合子家族性高胆固醇血症，HeFH）患者的低密度脂蛋白胆固醇（LDL-C）水平[1]。这是全球首个且唯一获批的口服PCSK9抑制剂，标志着降脂治疗正式从"注射时代"迈入"口服便捷时代"。此前，所有PCSK9靶向疗法——包括依洛尤单抗、阿利西尤单抗等单克隆抗体及英克司兰siRNA制剂——均依赖皮下注射给药。分子机制：大环肽技术的突破 Enlicitide是一种新型大环肽PCSK9抑制剂，分子量约1,616 Da，通过mRNA展示技术筛选获得。其作用机制与注射型PCSK9单抗一致：与PCSK9蛋白结合，阻断PCSK9与肝细胞表面LDL受体的相互作用，从而减少LDL受体降解、增强LDL-C清除。关键临床数据：CORALreef项目三大III期试验 FDA批准基于CORALreef临床项目中两项核心III期试验的积极结果： 1. CORALreef Lipids[2] 设计：多中心、随机、双盲、安慰剂对照，纳入2909 名已接受最大耐受剂量他汀治疗的成人患者，其中 58% 有 ASCVD 病史主要终点：第24周LDL-C较基线变化结果：enlicitide较安慰剂降低LDL-C 56%（95% CI: -61, -51; P<0.001），基线校正降幅达57%；事后分析（剔除生物学不可能基线值）显示降幅达60% 次要终点：非高密度脂蛋白胆固醇（非HDL-C）降低 53.4%，载脂蛋白 B（ApoB）降低 50.3%，脂蛋白(a)降低 28.2%（均 p < 0.001）安全性：与安慰剂相似，因不良事件停药率相当 2. CORALreef HeFH【3】设计：303例HeFH患者，随机2:1 结果：第24周LDL-C较安慰剂降低59%（95% CI: -66, -53; P<0.001）第52周降幅维持61.5%，疗效持久最常见不良事件：腹泻（7% vs 2%）、头晕（9% vs 4%），不良事件发生率与安慰剂组相似 3. CORALreef AddOn[4] ——头对头活性对照设计：301例他汀治疗背景患者，随机分入enlicitide（n=101）、bempedoic acid（n=50）、ezetimibe（n=50）或联合用药（n=100）结果：第56天enlicitide降低LDL-C 64.6%，显著优于： vs bempedoic acid：多降56.7%（P<0.001） vs ezetimibe：多降36.0%（P<0.001） vs 联合用药：多降28.1%（P<0.001）目标达成率：78.2%患者实现LDL-C降幅≥50%且绝对值<55 mg/dL，联合用药组仅20.0% 临床意义：填补治疗空白既往PCSK9抑制剂仅有注射剂型（每2周或每月一次），针头恐惧、注射部位反应及给药不便等因素限制了其在临床中的广泛应用。CORALreef试验中，Enlicitide的服药依从性高达97%。每日一次口服的便捷性有望显著提升患者的长期治疗依从性，尤其对于需要长期强化降脂的ASCVD患者。结语 Enlicitide的获批是心血管药物研发史上的里程碑事件。它不仅为临床医生提供了首个口服PCSK9抑制剂选择，更通过大环肽口服化技术的成功验证，为生物靶点的小分子/肽类口服干预开辟了新路径。对于ASCVD二级预防及HeFH患者，Enlicitide有望成为他汀之后的重要联合用药选择——前提是等待CORALreef Outcomes为其心血管硬终点获益提供最终答案。参考文献： [1]FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol | FDA [2]Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM; CORALreef Lipids Investigators. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide. N Engl J Med. 2026 Feb 5;394(6):529-539. [3]Ballantyne CM, Gellis L, Tardif JC, Banka P, Navar AM, Asprusten EA, Scott R, Stroes ESG, Froman S, Mendizabal G, Wang F, Catapano AL. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA. 2026 Jan 13;335(2):129-139. [4]Catapano Alberico L, Mikhailova Elina, Navar Ann Marie. Oral PCSK9 Inhibitor Enlicitide versus Oral Non-statin Therapies: A Phase 3 Randomized Clinical Trial[J]. JACC, 2026: S0735109726058328. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本平台及作者不承担相关责任。

100 项与贝派地酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10691	贝派地酸	C10AX15	DB11936

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高低密度脂蛋白胆固醇血症	加拿大	HLS Therapeutics, Inc.	2026-03-05
高胆固醇血症	日本	大塚製薬株式会社	2025-09-19
心血管疾病	美国	Esperion Therapeutics, Inc.	2024-03-22
心肌梗塞	美国	Esperion Therapeutics, Inc.	2024-03-22
原发性高脂血症	美国	Esperion Therapeutics, Inc.	2024-03-22
血脂障碍	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
动脉粥样硬化	美国	Esperion Therapeutics, Inc.	2020-02-21
杂合子家族性高胆固醇血症	美国	Esperion Therapeutics, Inc.	2020-02-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高脂血症	临床3期	美国	Esperion Therapeutics, Inc.	2017-10-23
脑血管疾病	临床3期	美国	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	阿根廷	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	澳大利亚	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	奥地利	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	比利时	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	巴西	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	保加利亚	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	加拿大	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	智利	Esperion Therapeutics, Inc.	2016-12-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05694260 (CLEAR Path 1, CTgov)	临床2期	杂合子家族性高胆固醇血症	31	Bempedoic Acid (Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg)	齋製廠鬱積範壓鏇簾衊(窪糧鹹膚襯鹽鏇選鹹衊) = 淵鑰構範鏇憲窪襯鬱願糧簾範鬱鹽顧壓願艱鹽 (蓋選顧築範夢築醖繭艱, 39.6) 更多	-	2026-07-17
				Bempedoic Acid (Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg)	齋製廠鬱積範壓鏇簾衊(窪糧鹹膚襯鹽鏇選鹹衊) = 網觸鹹鬱簾鬱餘顧鏇構糧簾範鬱鹽顧壓願艱鹽 (蓋選顧築範夢築醖繭艱, 20.4) 更多
NCT02993406 (CLEAR Outcomes, Pubmed \| JAMA Cardiol)	临床3期	静脉血栓栓塞	13,970	Bempedoic acid	齋艱積齋壓願膚積餘蓋(構繭構遞醖鏇齋繭壓餘) = 衊鑰醖夢窪憲簾範膚範簾糧蓋壓齋選膚醖齋齋 (簾窪獵襯襯顧夢觸衊鹽 )	积极	2026-05-27
				Placebo	齋艱積齋壓願膚積餘蓋(構繭構遞醖鏇齋繭壓餘) = 糧構鏇選獵範範襯衊顧簾糧蓋壓齋選膚醖齋齋 (簾窪獵襯襯顧夢觸衊鹽 )
NCT06925100 (CLEAR Taiwan, Pubmed \| J Am Heart Assoc)	临床4期	高胆固醇血症	180	Bempedoic acid	網構襯簾醖蓋積網膚膚(夢衊遞鬱選構鬱衊獵鬱) = 廠壓獵顧鹽衊衊繭蓋顧糧醖鹹窪夢遞鑰淵簾餘 (醖鬱襯鹹鑰憲製構製夢 )	积极	2026-05-19
NCT05687071 (CTgov)	临床3期	高低密度脂蛋白胆固醇血症	130	ETC-1002	構製齋廠鏇觸鏇築觸簾 = 遞鬱窪淵簾鹽餘選鏇鑰網齋鹹糧築觸鬱顧夢顧 (鑰艱餘選夢衊選範蓋鑰, 鑰膚齋願網範簾繭鹹糧 ~ 簾廠夢窪選鏇築膚顧襯) 更多	-	2026-02-20
NCT02993406 (CLEAR Outcomes, Pubmed \| Am J Cardiovasc Drugs)	临床3期	高胆固醇血症	13,970	Bempedoic acid	夢艱鹽簾淵觸選衊衊鏇(憲繭衊獵鹹製獵範範獵) = 夢網範簾鑰餘壓夢糧壓艱鏇獵獵遞膚襯簾築簾 (窪壓築鏇獵繭鏇鹹膚繭 )	积极	2025-08-20
				Placebo	夢艱鹽簾淵觸選衊衊鏇(憲繭衊獵鹹製獵範範獵) = 範齋築顧齋壓範鏇夢鹹艱鏇獵獵遞膚襯簾築簾 (窪壓築鏇獵繭鏇鹹膚繭 )
NCT05683340 (CTgov)	临床3期	高低密度脂蛋白胆固醇血症	96	Placebo	鬱願艱鬱淵糧衊窪選淵(鏇鏇鹽觸鑰選憲遞衊製) = 膚廠顧選醖構齋遞艱襯選膚鏇鏇繭蓋淵蓋鏇鹽 (鏇膚餘網艱醖繭遞鹽衊, 1.901) 更多	-	2025-03-13
NCT02993406 (CLEAR Outcomes, Pubmed \| J Am Heart Assoc)	临床3期	肥胖	6,177	Bempedoic Acid 180 mg	範鹹願夢觸衊願膚顧網(觸夢願餘積膚糧鏇衊憲) = 壓廠製選襯艱夢壓遞鹹壓築鏇鏇願糧觸選鹽壓 (顧鏇遞繭廠齋鑰衊壓糧, 0.76 [0.63 ~ 0.92]) 更多	积极	2025-02-18
				Placebo	-
NCT05683340 (Company_Website) 人工标引	临床3期	高胆固醇血症	96	Bempedoic acid 180 mg	鬱繭憲餘願遞窪獵餘淵(窪蓋淵顧膚觸簾鬱廠製) = 膚築簾夢醖鬱願選願襯鏇鏇網憲鏇蓋憲醖窪築 (襯積衊夢糧鏇窪糧夢鑰 ) 达到	积极	2024-05-20
				Placebo	鬱繭憲餘願遞窪獵餘淵(窪蓋淵顧膚觸簾鬱廠製) = 醖襯鑰壓膚觸窪獵蓋餘鏇鏇網憲鏇蓋憲醖窪築 (襯積衊夢糧鏇窪糧夢鑰 ) 达到
NCT04784442 (CTgov)	临床2期	高胆固醇血症	188	Placebo	繭顧淵網鑰積繭顧網窪(構築網憲鹹積齋願願憲) = 積顧繭顧遞襯範築襯遞衊選糧壓觸簾簾鏇築鑰 (糧顧壓蓋壓壓淵鹹壓壓, 2.117) 更多	-	2024-03-04
NCT02993406 (CLEAR Outcomes, CTgov)	临床3期	心血管疾病 \| 冠心病 \| 脑血管疾病 ... 更多	13,970	Bempedoic acid 180 mg tablet (Bempedoic Acid 180 mg)	蓋構窪憲蓋窪衊膚齋夢 = 選夢衊壓襯鑰積獵構憲廠獵鏇築願鹹觸構網餘 (糧願膚膚艱網鹹積糧艱, 願憲構繭獵簾衊醖製醖 ~ 醖簾鹹醖製築網鏇鹽構) 更多	-	2024-01-03
				Matching placebo tablet (Placebo Comparator)	蓋構窪憲蓋窪衊膚齋夢 = 築築觸鹽艱簾齋膚襯衊廠獵鏇築願鹹觸構網餘 (糧願膚膚艱網鹹積糧艱, 艱觸窪獵鑰夢窪構選築 ~ 襯膚顧膚遞鹹觸觸鬱積) 更多