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更新于：2025-04-26
Albiglutide
阿必鲁肽
更新于：2025-04-26
概要
基本信息
原研机构 |
在研机构- |
最高研发阶段撤市 |
首次获批日期 欧盟 (2014-03-20), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 39861
来源: *****
关联
48
项与 阿必鲁肽 相关的临床试验ChiCTR2400086382
Safety and efficacy of GLP-1RA combined with Banxia Xiexin Decoction in the treatment of type 2 diabetes
开始日期2024-07-15 |
申办/合作机构- |
ChiCTR2300073482
A real-world study of GLP-1RA in the treatment of diabetic nephropathy
开始日期2023-07-15 |
申办/合作机构- |
ChiCTR2300073001
Effect of long-term treatment with GLP-1RA on cardiovascular outcomes in patients with type 2 diabetes mellitus: an ambispective cohort study
开始日期2023-07-01 |
申办/合作机构- |
100 项与 阿必鲁肽 相关的临床结果
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100 项与 阿必鲁肽 相关的转化医学
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100 项与 阿必鲁肽 相关的专利（医药）
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288
项与 阿必鲁肽 相关的文献（医药）2025-05-01·AMERICAN JOURNAL OF KIDNEY DISEASES
Kidney and Cardiovascular Outcomes Among Patients With CKD Receiving GLP-1 Receptor Agonists: A Systematic Review and Meta-Analysis of Randomized Trials
Review
作者: Pan, Heng-Chih ; Hsu, Tsuen-Wei ; Chen, Jui-Yi ; Yang, Shao-Yu ; Liu, Jung-Hua ; Lai, Chun-Fu ; Wu, Vin-Cent
RATIONALE & OBJECTIVE:
Glucagon-like peptide 1 (GLP-1) receptor agonists improve cardiac and kidney outcomes in patients with diabetes; however, their efficacy in individuals with reduced estimated glomerular filtration rate (eGFR) is uncertain. This study evaluated the effects of GLP-1 receptor agonists on kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD).
STUDY DESIGN:
Systematic review and meta-analysis of randomized controlled trials (RCTs) reported through May 25, 2024.
SETTING & STUDY POPULATIONS:
Adult participants in RCTs with baseline eGFR<60mL/min/1.73m2.
SELECTION CRITERIA FOR STUDIES:
RCTs including adults (≥18 years old) with varying degrees of kidney function, including individuals with CKD characterized by a baseline eGFR of<60mL/min/1.73m2, that compared GLP-1 receptor agonists with control treatments with respect to a composite kidney outcome, all-cause mortality, or a composite CV disease outcome. From among 212 screened studies, 12 trials involving that included participants with baseline eGFR<60mL/min/1.73m2 were included.
DATA EXTRACTION:
Two independent investigators extracted the data.
ANALYTICAL APPROACH:
Pooled odds ratios (ORs) for composite kidney outcome, all-cause mortality, and composite CV outcome were estimated using random-effects models. Evidence certainty was assessed using the GRADE system.
RESULTS:
The analyses included 17,996 RCT participants with baseline eGFR<60mL/min/1.73m2. GLP-1 receptor agonists were significantly associated with a reduced risk of the composite kidney outcome (OR, 0.85 [95% CI, 0.77-0.94]; P=0.001) with low heterogeneity (I2<0.01%). GLP-1 receptor agonists were also associated with a reduced the risk of a>30% eGFR decline (OR, 0.78; P=0.004), a>40% decline (OR, 0.76; P=0.01), and a>50% decline (OR, 0.72; P<0.001). Risk of all-cause mortality was also lower in the GLP-1 receptor agonist group (OR, 0.77 [95% CI, 0.60-0.98], P=0.03), though there was high heterogeneity (I2=71.6%). Composite CV outcomes were also lower with the use of a GLP-1 receptor agonist (OR, 0.86 [95% CI, 0.74-0.99], P=0.03; I2=40.3%). Sensitivity analyses restricted to human GLP-1 backbone agents showed enhanced benefits.
LIMITATIONS:
Inconsistent kidney outcome definitions, focus on diabetic populations in most studies, and potential publication bias.
CONCLUSIONS:
GLP-1 receptor agonists improved kidney and CV outcomes, and survival in patients with CKD enrolled in an array of clinical trials.
REGISTRATION:
Registered at PROSPERO with identification number CRD42023449059.
PLAIN-LANGUAGE SUMMARY:
Glucagon-like peptide 1 (GLP-1) receptor agonists reduce body weight and improve glycemic control. They also have been shown to protect the heart and kidney in people with diabetes. However, the extrapolation of these findings to those with chronic kidney disease (CKD) is uncertain. This study meta-analyzed data from clinical trials focusing on patients with CKD and noted that GLP-1 receptor agonists may slow kidney disease progression and lower the risk of heart disease, stroke, and death. These findings suggest that GLP-1 receptor agonists offer multiple kidney and cardiovascular benefits to people with CKD.
2025-03-16·POSTGRADUATE MEDICAL JOURNAL
Effects of new hypoglycemic drugs on patients with heart failure: a systematic review and network meta-analysis
Review
作者: Chen, Jun ; Song, Ruirui ; Gao, Hongmei ; Liu, Fang ; Sun, Songtao ; Shi, Xiaojing
Abstract:
Background:
Currently, there is no relevant study comparing sodium-dependent glucose transporter 2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), and dipeptidyl peptidase inhibitor (DPP4i) head to head to evaluate their comprehensive impact on heart failure patients.
Methods:
We conducted a comprehensive literature search across multiple databases. Utilizing the risk of bias tool from the Cochrane Collaboration, the methodological quality of included studies was critically assessed and potential publication bias was examined via funnel plots.
Results:
All results are presented as mean difference; 95% confidence interval (MD; 95% CI). The network meta-analysis indicated that in regards to left ventricular function, there is a big difference in the left ventricular ejection fraction (LVEF) of Empagliflozin 25 mg (13.64; 0.26, 27.01) compared to Canagliflozin 100 mg; and significant differences in the left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) of Dapagliflozin 10 mg (−0.76; −1.27, −0.25 and −0.95; −1.86, −0.05), Vildagliptin 50 mg (−1.05; −1.47, −0.63 and −1.12; −2.19, −0.05), and Sitagliptin 100 mg (−1.34; −2.31, −0.38 and −1.89; −3.50, −0.27) compared to Empagliflozin 10 mg. In terms of the quality of life, there are significant differences in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) and the Quality of life score of Sitagliptin 100 mg (408.08; 213.59, 602.57 and 3.74; 1.57, 5.92) compared to Dapagliflozin 5 mg. In terms of the cardiovascular outcome events, there is a significant difference in the heart failure rehospitalization rate of Dapagliflozin 10 mg (0.45; 0.25, 0.82) and Empagliflozin 10 mg (0.48; 0.28, 0.81) compared to Liraglutide 1.8 mg. Further significant differences are found in the all-cause mortality of Dapagliflozin 10 mg (0.81; 0.66, 0.98) compared to Vildagliptin 50 mg; the cardiovascular death of Albiglutide 30 mg (0.49; 0.28, 0.86) compared to Exenatide 2 mg; and the arrhythmic events of Liraglutide 1.8 mg (0.49; 0.26, 0.90) compared to Empagliflozin 10 mg. The network meta-analysis of SGLT2i, GLP-1RA, and DPP4i as a class of drugs showed that GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.
Conclusions:
GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.Key message What is already known on this topic—It has been confirmed that three new hypoglycemic drugs have a protective effect on the cardiovascular system. Studies have shown that sodium-dependent glucose transporter 2 inhibitors (SGLT2i) can improve cardiovascular outcomes and enhance the quality of life of heart failure patients. Currently, SGLT2i is widely used in the clinical treatment of heart failure, and related studies have shown that glucagon-like peptide-1 receptor agonists (GLP-1RA) and dipeptidyl peptidase inhibitor (DPP4i) also play important roles in the treatment of heart failure. What this study adds—However, there is no relevant research on whether these drugs’ clinical efficacy is dose-dependent. How this study might affect research, practice, or policy—This study included different doses of hypoglycemic drugs and used a network meta-analysis method to comprehensively evaluate the effects of three hypoglycemic drugs on heart function, quality of life, and prognosis in heart failure patients, providing a basis for clinical practice.
2025-02-19·EUROPEAN HEART JOURNAL SUPPLEMENTS
Oral semaglutide: an innovative paradigm in the management of cardiovascular risk in patients with Type 2 diabetes
Article
作者: Temporelli, Pier Luigi
Abstract:
Cardiovascular (CV) diseases (CVDs) remain a leading global health issue, causing about one-third of all deaths worldwide. Among modifiable CV risk factors (systolic blood pressure, non-HDL cholesterol, diabetes, body mass index, and smoking), diabetes is a leading one, accounting for established CVDs in 34.8% of diabetic patients, with an increasing prevalence of disease. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), like exenatide, liraglutide, albiglutide, dulaglutide, and semaglutide, initially developed for treatment of Type 2 diabetes, have shown CV benefits, and international guidelines recommend now GLP-1 RAs as preferred drugs for CV prevention in diabetic patients regardless of baseline HbA1c or metformin use. Among GLP-1 RAs, subcutaneous semaglutide has demonstrated cardio-metabolic risk factors reduction and efficacy in CV prevention. Development of oral semaglutide represents the evolution of the molecule. The PIONEER study programme confirmed the efficacy of oral semaglutide in reducing HbA1c, body weight, and cardio-metabolic risk factors as well as CV safety. Notably, independently by route of administration, semaglutide showed early CV benefits, suggesting mechanisms beyond glycaemic control or weight reduction. Semaglutide, combining potent cardio-metabolic effects with oral route, emerges as a pivotal treatment for high-risk Type 2 diabetes patients, offering comprehensive CV protection independent of HbA1c levels.
43
项与 阿必鲁肽 相关的新闻（医药）2025-04-13
▎药明康德内容团队编辑胰高血糖素样肽-1受体激动剂（GLP-1RA）已被证实具有很大治疗潜力，包括降糖、减重，以及降低重大心血管不良事件风险和改善糖尿病患者肾脏预后。近期研究证据显示，GLP-1RA或有益于改善射血分数保留型心力衰竭（HFpEF）的患者的肾脏结局。部分大型临床试验亚组分析结果表明，GLP-1RA和钠-葡萄糖共转运蛋白2抑制剂（SGLT-2i）联合治疗，可减少糖尿病患者心力衰竭住院和肾脏疾病复合事件发生率。在此基础上加用非甾体盐皮质激素受体拮抗剂（MRA）非奈利酮，可能进一步强化心肾保护作用，相关研究结果显示，三联治疗预估可将心血管不良事件风险和慢性肾病进展风险分别降低35%和58%。但GLP-1RA+SGLT-2i+非奈利酮三联疗法的临床效益及适用人群仍需更多研究验证。GLP-1RA可降低糖尿病患者主要不良心血管事件发生风险和肾脏不良结局风险糖尿病是心血管疾病和慢性肾病最重要的危险因素之一。相比于无糖尿病患者，糖尿病患者罹患动脉粥样硬化性心血管疾病的风险高出2~4倍。慢性肾病是糖尿病的主要微血管并发症，会增加心血管疾病和死亡的风险。控制血糖水平有助于预防慢性肾病微血管并发症和心血管事件的发生。对于糖尿病合并心血管疾病或存在多种心血管和肾脏风险的患者，GLP-1RA是治疗可选择用药之一。LEADER试验纳入了2型糖尿病合并心血管高风险的患者9340例，研究人员将患者随机分配接受利拉鲁肽或安慰剂治疗。研究结果显示，平均随访3.8年，相比于安慰剂组，利拉鲁肽组患者的主要不良心血管事件（心血管死亡、非致死性心肌梗死或非致死性卒中的复合终点）减少了13%（HR=0.87）。SUSTAIN-6试验则显示，在2型糖尿病合并心血管高风险患者中，相比于安慰剂组，司美格鲁肽组（皮下注射，每周0.5 mg或1 mg）心血管不良事件风险降低26%（HR=0.74），卒中风险降低了26%。后续Harmony Outcomes、REWIND、AMPLITUDE-O等研究也证实了GLP-1RA在降低2型糖尿病合并心血管高风险患者心血管不良事件、心肌梗死和卒中风险方面的作用。GLP-1RA不仅具有降糖的作用，也具有减重效应。SELECT试验在肥胖[体重指数（BMI）≥27 kg/m2]合并心血管疾病但无糖尿病的患者中开展，探索使用GLP-1RA对于预防心血管事件发生的作用。研究结果显示，在平均3.3年的观察期内，相比于安慰剂，皮下注射司美格鲁肽可使患者体重较基线降低9.39%、心血管不良事件风险降低20%（HR=0.80），尤其是心肌梗死风险降低28%（HR=0.72）。该研究结果提示，GLP-1RA心血管保护作用与减重相关，而非降糖作用。荟萃分析结果表明，GLP-1RA可将糖尿病合并心血管高风险患者的心力衰竭住院率降低约10%。但关于GLP-1RA降低心力衰竭住院风险的研究结果并不完全一致。FIGHT试验纳入因急性心力衰竭住院的射血分数降低的心力衰竭患者300例。所有患者中位左心室射血分数为25%；82%患有缺血性心脏病、59%患有2型糖尿病。结果显示，利拉鲁肽组与安慰剂组死亡（HR=1.10）和心力衰竭再住院（HR=1.30）风险无显著差异，不同糖尿病状态亚组分析结果也相似。因此，关于射血分数降低的心力衰竭患者能否从GLP-1RA用药中获益，仍有待更多证据进行验证。GLP-1RA改善肾脏结局获益的证据多来源于次要结局或探索性分析，其机制可能与大量蛋白尿进展抑制有关，但对其他临床重要肾脏终点的影响尚不明确，包括肾小球滤过率（eGFR）下降速度、开始肾脏替代治疗的时间等。FLOW试验评估皮下注射司美格鲁肽对2型糖尿病患者慢性肾病影响，研究纳入患者3533例，随机接受司美格鲁肽或安慰剂治疗。主要结局为首次肾功能衰竭的时间（持续eGFR<15 ml/min/1.73m2或开始慢性肾脏替代治疗）。研究结果显示，司美格鲁肽组eGFR较基线下降≥50%或因肾脏或心血管原因死亡风险较低（HR=0.76）。肾脏替代治疗的开始时间延迟，但未达到统计学意义（HR=0.84）。因此，司美格鲁肽或可影响2型糖尿病合并慢性肾病患者的临床肾脏终点。GLP-1RA和SGLT-2i的潜在互补证据一项比较GLP-1RA与SGLT-2i疗效的荟萃分析中，纳入5项GLP-1RA相关和3项SGLT-2i相关试验，涉及77242例患者。与安慰剂组相比，GLP-1RA组的心血管不良事件风险降低了12%（HR=0.88），SGLT-2i组的心血管不良事件风险降低了11%（HR=0.89），这表明GLP-1RA和SGLT-2i降低心血管不良事件风险的程度相似。此外，多项荟萃分析结果显示，无论是否患有糖尿病，SGLT2i在射血分数降低的心力衰竭和射血分数保留的心力衰竭中都能将心力衰竭住院降低约30%。GLP-1RA联合SGLT-2i能否进一步降低糖尿病患者的心血管和肾脏事件的发生？理论上来说是可行的，但尚缺乏相关试验来直接验证联合疗法的效果。此前，AMPLITUDE-O试验和Harmony Outcomes试验分别有15.2%（n=618）和6.1%（n=575）的患者在基线时使用SGLT-2i。AMPLITUDE-O试验事后分析发现，基线时SGLT-2i使用者和未使用者的心血管不良事件风险分别降低了30%和26%（HR=0.70和0.74，相互作用P=0.70）、心力衰竭住院风险分别降低了77%和30%（HR=0.23和0.70，相互作用P=0.35）、复合肾脏结局风险分别降低了48%和30%（HR=0.52和0.70，相互作用P=0.38）。Harmony Outcomes试验事后分析未对肾脏结局进行探讨，但也观察到了类似的结果。DECLARE-TIMI 58试验中，4.4%患者基线时使用GLP-1RA，结果显示，SGLT-2i（达格列净）可降低心血管不良事件、心力衰竭住院和复合肾脏结局的风险，这种作用与基线是否使用GLP-1RA无关。从现有研究来看，GLP-1RA和SGLT-2i的作用机制基本上是独立的，但仍需要进一步研究，以评估二者联合治疗是否能够带来更大的临床益处。GLP-1RA+SGLT-2i+非奈利酮的三联治疗策略FIDELIO-DKD、FIGARO-DKD及FIDELITY试验表明，非奈利酮可减少慢性肾病合并糖尿病患者的心血管和肾脏事件发生率，这主要得益于非奈利酮可降低心力衰竭住院风险。这3项大型临床试验的FINE-HEART汇总分析中，非奈利酮降低了心力衰竭住院、白蛋白尿进展复合终点（排除心血管事件影响）、心血管不良事件和全因死亡的风险。参与者中，基线分别有5.8%和8.9%的患者使用GLP-1RA和SGLT-2i，无论这些药物的使用情况如何，非奈利酮对心血管死亡的治疗效果都是一致的。非奈利酮对心血管和肾脏事件的临床益处也不太可能受到GLP-1RA或SGLT-2i联合治疗的影响。但关于非奈利酮联合GLP-1RA和SGLT-2i的附加作用的临床证据仍然有限。有学者将GLP-1RA、SGLT-2i和非奈利酮的相关临床试验数据进行交叉试验分析，以估计三联治疗的效果。研究结果显示，在糖尿病和蛋白尿患者中，相比于常规治疗，三联治疗组的心血管不良事件、心力衰竭住院和慢性肾病进展的风险分别降低了35%（HRs=0.65）、55%（HRs=0.45）和58%（HRs=0.42）。从结果来看，潜在原因是GLP-1RA、SGLT-2i和非甾体MRA的作用机制通常互补和独立、可能部分重叠。因此，这三类药物结合时的效果可能相加。此外，研究还发现，对于50岁以上的患者，相比于单独使用常规疗法，采用三联疗法治疗的患者心血管不良事件、心力衰竭住院和慢性肾病的无事件生存期分别延长了3.2年、3.2年和5.5年。这提示，相比传统疗法或单独用药，GLP-1RA、SGLT-2i和非奈利酮的三联疗法具有更强的心肾保护作用。鉴于现有证据，三联疗法有望提供额外的心脏保护，但需要开展进一步的随机对照试验，以明确三联疗法是否具有相加或协同作用。总结和未来前景联合用药可能进一步增强治疗效果，根据患者情况选择合适药物是未来心血管-肾脏代谢综合征领域的精准治疗方向。2型糖尿病和/或肥胖患者可能受益于联合用药，并改善心血管和肾脏结局。GLP-1RA+SGLT-2i+非奈利酮的方案，可能在心血管和肾脏保护方面具有互补作用。但治疗策略的制定仍需考虑到以下几方面的差异：1）明确从联合治疗中获益的人群；2）明确加强治疗的理想时机和优先级，因为目前的证据不足以弥补这一空白；3）患者接受联合治疗如何维持长期依从性和安全性。本文作者：泰达国际心血管病医院 郑刚推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料（可上下滑动查看）[1] Wong ND, Sattar N. 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Does elevated glucose promote atherosclerosis? Pros and Cons Circ Res. 2016;119(2):190–3. [7] Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93. [8] Ueki K, Sasako T, Okazaki Y, et al. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endo crinol. 2017;5(12):951–64. [9] Gaede P, Lund-Andersen H, Parving HH, et al. Effect of a mul tifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–91. [10] Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Associa tion (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–86. [11] Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474–84. [12] Bjorkegren JLM, Lusis AJ. Atherosclerosis: recent developments. Cell. 2022;185(10):1630–45. [13] Abel ED, Gloyn AL, Evans-Molina C, et al. Diabetes mellitus-progress and opportunities in the evolving epidemic. Cell. 2024;187(15):3789–820. [14] Ritchie RH, Abel ED. Basic mechanisms of diabetic heart disease. Circ Res. 2020;126(11):1501–25. [15] van Raalte DH, Bjornstad P, Cherney DZI, et al. Combination therapy for kidney disease in people with diabetes mellitus. Nat Rev Nephrol. 2024;20(7):433–46. [16] Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–22. [17] Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular out comes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–44. [18] Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-con trolled trial. Lancet. 2018;392(10157):1519–29. [19] Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo controlled trial. Lancet. 2019;394(10193):121–30. [20] Gerstein HC, Sattar N, Rosenstock J, et al. Cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes. N Engl J Med. 2021;385(10):896–907. [21] Ussher JR, Drucker DJ. Glucagon-like peptide 1 receptor agonists: cardiovas cular benefits and mechanisms of action. Nat Rev Cardiol. 2023;20(7):463–74. [22] Giugliano D, Scappaticcio L, Longo M, et al. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs. Cardiovasc Diabetol. 2021;20(1):189. [23] Sattar N, Lee MMY, Kristensen SL, et al. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials. Lancet Diabetes Endocrinol. 2021;9(10):653–62. [24] Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247–57. [25] Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221–32. [26] Sawami K, Tanaka A, Node K. Anti-obesity therapy for cardiovascular disease prevention: potential expected roles of glucagon-like peptide-1 receptor agonists. Cardiovasc Diabetol. 2022;21(1):176. [27] Margulies KB, Hernandez AF, Redfield MM, et al. Effects of liraglutide on clinical stability among patients with advanced heart failure and reduced ejection fraction: a randomized clinical trial. JAMA. 2016;316(5):500–8. [28] Jorsal A, Kistorp C, Holmager P, et al. Effect of liraglutide, a glucagon like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial. Eur J Heart Fail. 2017;19(1):69–77. [29] Kosiborod MN, Abildstrom SZ, Borlaug BA, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. N Engl J Med. 2023;389(12):1069–84. [30] Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in patients with obesity-related heart failure and type 2 diabetes. N Engl J Med. 2024;390(15):1394–407. [31] Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. N Engl J Med. 2024;391(2):109–21. [32] Kosiborod MN, Deanfield J, Pratley R, et al. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024;404(10456):949–61. [33] Petrie MC, Borlaug BA, Butler J, et al. Semaglutide and NT-proBNP in obesity-related HFpEF. J Am Coll Cardiol. 2024;84(1):27–40. [34] Verma S, Petrie MC, Borlaug BA, et al. Inflammation in obesity-related HFpEF: The STEP-HFpEF Program. J Am Coll Cardiol. 2024;84(17):1646–62.免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。分享，点赞，在看，传递医学新知
临床结果临床成功
2025-03-18
With decades of experience in pharmaceutical development and extensive genetic medicine expertise, Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, will provide strategic guidance for CAMP4’s multiple drug development efforts CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced the appointments of Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Company’s Board of Directors. “We are delighted to welcome Drs. Williams and Stewart to our Board of Directors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “With their combined expertise spanning critical aspects of R&D and clinical development, we will benefit greatly from their strategic insights as we advance our lead clinical program for urea cycle disorders and our preclinical program for SYNGAP1-related disorders, while continuing to develop additional RNA-targeting medicines designed to upregulate gene expression and meaningfully address diseases where we believe modest increases in protein levels can have a tremendous impact on the lives of patients.” Dr. Williams commented, “CAMP4’s approach is opening exciting possibilities to upregulate gene expression, a long-sought-after and challenging feat in the field of genetic medicine. I look forward to working with the team to unlock the full potential of this approach and ultimately advance novel therapeutics to the clinic.” Dr. Stewart added, “I’m thrilled to join the CAMP4 team and support its mission of advancing programmable RNA therapeutics for genetic diseases where decreased protein expression drives disease pathophysiology. By pioneering new ways to restore gene expression, CAMP4 has the potential to bring life-changing therapies to patients who currently have limited or no disease-modifying treatment options.” With over 30 years in the biopharma industry, Dr. Williams has contributed to the development of several transformative drugs, including LEUKINE®, ENBREL®, ADCETRIS®, TECFIDERA®, APROLIX®, ELOCTATE®, and SPINRAZA®. He was previously President of R&D at Sana Biotechnology and the Founding President & CEO of Codiak BioSciences. Prior to Sana, Dr. Williams served as EVP of R&D at Biogen, and earlier in his career was CEO of ZymoGenetics (acquired by BMS), and held leadership roles at Seattle Genetics, Amgen, and Immunex. Over the course of his career, he has served on the Board of Directors and Advisory Boards of more than two dozen biotech companies. Dr. Stewart currently serves as a Senior Medical Advisor to several biopharma companies, and was most recently the Chief Medical Officer at Rhythm Pharmaceuticals. Prior to this position, he served as Head of R&D at Novelion Therapeutics. Before joining Novelion, he served as corporate Chief Medical Officer at GlaxoSmithKline. With extensive clinical development experience, he has led studies across all stages, from first-in-human trials to large Phase 4 cardiovascular outcome studies. Dr. Stewart has played a key role in the successful registration and launch of multiple therapies, including AVANDIA®, ARIXTRA®, TANZEUM®, and XOLREMDI®. Before transitioning to industry, he served as a Consultant Physician and Head of Clinical Services at the Diabetes Centre in Newcastle upon Tyne, UK, where his research was focused on lipid metabolism and type 2 diabetes. About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of rare and prevalent genetic diseases where increasing healthy protein levels may offer meaningful therapeutic benefits. Our approach allows for targeted gene upregulation by harnessing a fundamental mechanism of how genes are controlled. To increase gene expression, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com
高管变更寡核苷酸
2025-01-08
·梅斯医学
“2024年度中国内分泌领域十大医学研究”正式揭晓。回望2024，我国科学家在内分泌病领域取得了丰硕的研究成果，为世界医学的发展做出了巨大的贡献。
梅斯医学已连续7年发布了年度十大医学进展，研究内容面向中国学者在医学领域取得的重大科学进展和标志性成果，这些研究展现了我国研究实力和学术水平，同时在推进医疗实践、改善医疗质量方面具有重大意义。
在内分泌领域，今年我们依旧甄选出15项研究进入终选，采取网络投票的方式进行评选，得票数排名前10位入选“2024最受瞩目的中国十大医学研究"。（注：本次排名顺序根据线上票选数量进行排名，若出现总分相同的情况，将按照投票序号前后顺序进行依次排列。）
— 01 —
JAMA Network Open：郭立新团队发现5+2轻断食联合代餐饮食方式可大幅降糖减重
doi: 10.1001/jamanetworkopen.2024.16786
代餐是一种预先包装的食品或饮料，可替代1餐或多餐食物，并能提供人体所需的能量。限制饮食，也就是我们日常提到的“轻断食”或“间歇性饮食（IF）”。5：2间歇性饮食是其中的一种饮食方法，即每周有2天断食日（能量摄入为正常饮食能量摄入的1/4），其余5天正常进食。目前尚不明确，超重/肥胖的2型糖尿病患者使用代餐联合5：2间歇性饮食能否带来1+1＞2的效果？
在研究中，5：2代餐组的患者食用低能量的代餐产品，即一周内患者有2天非连续的日子用代餐代替3次正餐。在其余5天，患者可以自行选择早餐和午餐，但晚餐食用1份代餐。研究人员鼓励所有患者监测自己的热量摄入。在这16周期间，饮食摄入量被记录在日记中。在二甲双胍组，患者每天服用二甲双胍0.5 g，早晚各一次。如果初始药物剂量耐受性良好，则将其增加到每天2 g。在恩格列净组，患者服用10 mg恩格列净，每日一次。主要结局是HbA1c水平从基线到16周的变化情况。次要结局包括体重、体重指数（BMI）、腰围、臀围、腰臀比、收缩压和舒张压、空腹血糖（FPG）水平、空腹胰岛素水平等，并对胃肠道反应、尿路和生殖系统感染、低血糖和高血糖等不良事件进行了评估。
结果显示，相比于降糖药物二甲双胍或恩格列净，在16周内，5:2间歇性饮食+代餐饮食方式使2型糖尿病患者的血糖水平下降幅度更大，体重减轻幅度更大，或可作为一种有效的措施来干预早期2型糖尿病。
发表期刊：JAMA Netw Open . 2024 Jun 3;7(6):e2416786
通讯作者/关键作者：郭立新
主要作者单位：北京医院国家老年医学中心
— 02 —
JACC：葛均波/严励团队发现3个月一次新型PCSK9抑制剂，约85%患者“坏胆固醇”达标！
doi: 10.1016/j.jacc.2024.07.035
低密度脂蛋白胆固醇（LDL-C，俗称“坏胆固醇”）是动脉粥样硬化心血管疾病（ASCVD）发生、发展的主要危险因素。目前的临床实践指南建议，将LDL-C作为管理血脂异常的主要目标。他汀类药物是降LDL-C治疗的首选，中等强度的他汀类药物可以降低LDL-C水平约30%~50%。然而，考虑他汀类药物的耐受性以及需要每日用药对患者长期依从性的影响，亟需更长效安全的治疗选择。
瑞卡西单抗（Recaticimab）是一种选择性靶向PCSK9的人源化IgG1型单克隆抗体，拥有较长的半衰期，给药灵活且频率较少。这种方案相较于频繁的给药计划，可能会提高患者的依从性。REMAIN-1是一项随机、双盲、安慰剂对照的3期临床研究，在中国59个医学中心开展，旨在评估瑞卡西单抗在非家族性高胆固醇血症和混合型高脂血症患者中的疗效和安全性。
结果显示，不同剂量的瑞卡西单抗单药治疗方案可使LDL-C较基线降幅达约50%，约85%患者治疗后达到了LDL-C控制目标（<2.6 mmol/L），且具有良好的安全性。此外，瑞卡西单抗给药间隔最长可达12周，有利于改善患者的依从性。
发表期刊：J Am Coll Cardiol . 2024 Nov 12;84(20):2026-2036
通讯作者/关键作者：葛均波，严励
主要作者单位：复旦大学附属中山医院，中山大学孙逸仙纪念医院
— 03 —
NEJM：宁光院士团队发现强化降压可将糖尿病患者心血管事件风险降低21%！
doi: 10.1056/NEJMoa2412006
收缩压升高是糖尿病患者最常见的合并症，增加了糖尿病患者患心血管疾病的风险，并且是这些患者患心血管疾病的最易改变的风险因素。但目前关于2型糖尿病患者有效的收缩压治疗目标的证据尚无定论。因此，研究者进行了糖尿病血压控制目标（Blood Pressure Control Target in Diabetes， BPROAD）试验，以研究在降低2型糖尿病患者发生主要心血管疾病的风险方面，以收缩压小于120mmhg为目标的强化治疗是否比收缩压小于140mmhg的标准治疗更有效。
BPROAD研究是一项随机、开放标签、结局评估者持盲、平行组设计的临床试验，纳入了中国大陆145个二级和三级医院的12821名50岁及以上、收缩压升高合并心血管风险增加的2型糖尿病患者。
结果显示，在2型糖尿病合并高血压患者中，在谨慎监测多种降压药物使用过程中低血压与电解质水平的前提下，与降低收缩压至<140 mm Hg相比，降低收缩压至<120 mm Hg能显著减少21%的主要心血管疾病相对风险。BPROAD研究是继里程碑式ACCORD研究之后，聚焦2型糖尿病合并高血压患者强化与常规降压治疗的临床研究，也是迄今为止样本量最大的评价降压目标的随机对照临床试验。
发表期刊：N Engl J Med . 2024 Nov 16
通讯作者/关键作者：宁光院士，王卫庆，毕宇芳，徐瑜
主要作者单位：上海交通大学医学院附属瑞金医院
— 04 —
Cell：沈中阳/邓宏魁/王树森教授团队使用化学重编程多能干细胞，成功治疗1型糖尿病
doi: 10.1016/j.cell.2024.09.004
多能干细胞（Pluripotent stem cell，PSC）因其具有自我更新和分化成功能细胞类型的能力，因此作为无限的细胞来源，在诸如胰岛移植等细胞替代疗法中显示出巨大潜力。
研究团队将化学重编程多能干细胞分化而来的胰岛（CiPSC-islets）移植到了一名1型糖尿病（T1D）患者的腹直肌前鞘下，获得了可耐受的安全性，并且在1年随访中不再需要外源胰岛素治疗，且恢复了血糖控制。这名患者的治疗效果鼓舞人心，支持了腹直肌前鞘下CiPSC-胰岛移植治疗1型糖尿病（T1D）的可行性。
发表期刊：Cell . 2024 Oct 31;187(22):6152-6164.e18
通讯作者/关键作者：沈中阳、邓宏魁，王树森
主要作者单位：南开大学，天津市第一中心医院，北京大学
— 05 —
STTT：翁建平/侯凡凡院士/纪立农教授团队首次证明早期胰岛素治疗可降低新诊断T2DM患者心脑血管并发症风险
doi: 10.1038/s41392-024-01854-9
新诊断2型糖尿病（T2DM）患者早期胰岛素治疗，可以有效改善血糖控制并恢复β细胞功能，但能否改善患者长期心血管结局，仍缺乏相关证据。这项基于中国人群病例登记大数据库，探索新诊断T2DM患者早期胰岛素治疗对长期心血管结局影响的真实世界研究，客观反映了20多年来我国在T2DM早期防治方面所取得的成绩。研究结果显示，新诊断T2DM患者接受早期胰岛素治疗与未接受该治疗策略相比，卒中风险降低31%，心衰住院风险降低28%，冠心病风险无显著差异。
该研究印证了早期胰岛素治疗可改善新诊断T2DM患者病程，继续夯实了百年经典药物胰岛素在糖尿病治疗中的基石地位。随着国际学术交流进一步深入，这一中国原创成果必将助力全球T2DM治疗策略提质升级。
发表期刊：Signal Transduct Target Ther . 2024 Jun 6;9(1):154
通讯作者/关键作者：翁建平，侯凡凡院士，纪立农
主要作者单位：中国科学技术大学，南方医科大学南方医院，北京大学人民医院
— 06 —
BMJ：李延兵团队提出“强化-简化”糖尿病治疗新策略
doi: 10.1056/NEJMoa2403614
近年来，随着生活方式的转变和肥胖发病率升高，2型糖尿病的发病率居高不下。糖尿病治疗方案是升阶梯式的，即采用降糖药物不断增加、复杂化的方式进行应对进行性的血糖升高和病情进展。但这和患者简化方案的要求背道而驰，长期疗效也无法令人满意，很难避免远期的慢性并发症。
有鉴于此，研究团队设计了“强化－简化”新策略，在胰岛素强化治疗后采用简化的口服降糖药物进行序贯治疗以维持治疗的获益，以期达到优化长期血糖控制的目的。研究团队组织进行了一项全国多中心、随机对照研究，验证这一治疗模式的有效性。该项目获得2018年国家重点研发计划和2019年广东省重点领域研发计划立项，具有重大的临床意义。
该研究为伴有严重高血糖的新诊断T2DM患者提供了一种降阶梯长期管理策略，即通过强化管理充分逆转高血糖后，采用简单易行的口服药方案进行维持，可以获得长期的优化血糖控制。这一方案是对现行“升阶梯”治疗模式的突破，能更直接和主动地打破糖尿病不断恶化的进程。
发表期刊：N Engl J Med 2024;391:1486-1498
通讯作者/关键作者：李延兵；刘烈华，柯伟健，李海
主要作者单位：中山大学附属第一医院，中山大学附属第七医院
JAMA：李小英教授团队利用替尔泊肽助力中国成年人群战胜肥胖
doi: 10.1001/jama.2024.9217
肥胖症已经成为全球性的公共健康问题，而我国的人口数量已达到14.25亿，更是面临着前所未有的肥胖挑战。据权威数据显示，预计到2030年，中国成人中超重和肥胖的患病率将飙升至70.5%，这意味着将有约8.1亿人受到肥胖症的困扰。
近年来，随着对肥胖症发病机制研究的深入，一些新型药物逐渐走入人们的视野。我国研究学者发不了一项研究成果，全面、系统地评估了新型降糖药物替尔泊肽在中国肥胖成人中用于减重的疗效和安全性，并深入探讨了替尔泊肽在减重、改善心血管代谢指标以及安全性方面的表现，为肥胖症治疗提供了新的选择和依据。
本研究通过随机、双盲、安慰剂对照试验，为替尔泊肽在中国肥胖成人中的应用提供了坚实的科学依据。研究不仅证实了替尔泊肽在减重和改善心血管代谢指标方面的显著效果，更通过精细化的剂量调整和干预措施，确保了治疗的安全性和适用性。这些发现不仅为中国肥胖症患者带来了新的治疗希望，也为全球肥胖症治疗研究贡献了宝贵的“中国数据”。
发表期刊：JAMA . 2024 Aug 20;332(7):551-560
通讯作者/关键作者：李小英
主要作者单位：复旦大学附属中山医院
— 07 —
JAMA Network Open：胡盛寿院士团队揭示近380万中国人群最佳“坏胆固醇”水平
doi: 10.1001/jamanetworkopen.2024.22558
低密度脂蛋白胆固醇（LDL-C，俗称“坏胆固醇”）是动脉粥样硬化性心血管疾病（ASCVD）的致病性且可改变危险因素之一。据估计，高LDL-C水平每年导致约430万人死亡，占全球死亡人数的7.7%。降脂治疗，尤其是他汀类药物，已被广泛用作ASCVD一级预防和二级预防的基本策略。在不同ASCVD风险的个体中，LDL-C与死亡率之间的不同关联，决定了临床实践中使用的不同脂质管理策略。那么，对于不同ASCVD风险人群来说，“坏胆固醇”水平控制在多少更合适？
基于中国心血管病高危人群早期筛查与综合干预项目（ChinaHEART）的前瞻性队列研究数据，研究团队纳入了近378.9万例参与者进行数据分析。研究表明，LDL-C水平与死亡率之间的关联，在不同ASCVD分层风险的人群中存在差异。不仅在一级和二级预防中，即使在ASCVD低风险人群中，都需要重视LDL-C水平控制，进行降脂治疗。低风险、一级和二级预防人群中的糖尿病患者，应接受更高频率的血脂监测和降血脂管理。
发表期刊：JAMA Netw Open . 2024 Jul 1;7(7):e2422558
通讯作者/关键作者：胡盛寿
主要作者单位：中国医学科学院阜外医院
— 08 —
The Innovation Medicine：胡盛寿、冯雪团队牵头发表跨学科多维度描绘肥胖全景图
doi: 10.59717/j.xinn-med.2024.100090
本综述横跨生活方式医学、内分泌系统、心血管系统、神经系统、呼吸系统、生殖系统、骨骼肌肉系统、免疫系统、肠道菌群、营养、运动、心理、睡眠等十三个学科领域，综合了大量文献，探讨肥胖的流行病学、病理生理机制、与多种疾病的关系，以及肥胖管理的策略，绘制了一幅当今肥胖研究领域的全景图，为肥胖与健康结果的复杂关系提供了跨学科多维度的视角。
发表期刊：The Innovation Medicine 2(3):100090
通讯作者/关键作者：胡盛寿，冯雪
主要作者单位：中国医学科学院阜外医院
— 09 —
Lancet：李舍予团队关于减肥药利弊的最新证据（Meta分析）
doi: 10.1016/S0140-6736(24)00351-9
超重和肥胖会导致多种健康问题，包括2型糖尿病、心血管疾病、抑郁症和恶性肿瘤等，是全球性的健康问题。越来越受到大众的关注。改变生活方式可能会改善生活质量和健康结果，但只有61%的超重和肥胖患者完成了生活方式规划。除了改变生活方式和减肥手术，药物治疗是减肥的重要替代或辅助治疗。
研究团队总结了有关减肥药利弊的最新证据。结果表明，在超重和肥胖的成年人中，芬特明-托吡酯和 GLP-1 受体激动剂被证明在减肥方面最有效。Semaglutide被证明是GLP-1受体激动剂中最有效的，并且显示出比任何其他药物更大的作用。荟萃分析进一步发现，纳曲酮-安非他酮（OR 2·69，95% CI 2.10至3.44）、芬特明-托吡酯（OR 2·40，1.68至3.44）、GLP-1 受体激动剂（OR 2.22，1.74至2.84) 和奥利司他 (OR 1·72，1.42至2.05) 与停药导致的不良事件增加有关。值得注意的是，GLP-1 受体激动剂中的Semaglutide在体重减轻 ≥5% 以及体重变化百分比方面的获益远大于其他药物，不良事件风险与其他药物相似。
随着人们对身材管理和健康的追求日益增强，对于超重和肥胖的成年人，芬特明-托吡酯和 GLP-1 受体激动剂是减轻体重的最佳药物，其中在众多GLP-1 激动剂中，Semaglutide可能是最有效的。
发表期刊：Lancet . 2024 Apr 6;403(10434):e21-e31
通讯作者/关键作者：李舍予；石清阳，汪洋，李静，田浩明
主要作者单位：四川大学华西医院
— 10 —
BMJ：万瑾毅发文GLP-1药物，谁的降糖效果最好，谁的减重效果最佳？
doi: 10.1136/bmj-2023-075707
GLP-1RA是胰高糖素样肽1的类似物，通过促进胰岛素合成与分泌，抑制胰高血糖素分泌，减缓胃排空和增强饱腹感等机制来调节血糖浓度。短效GLP-1RA可降低夜间和空腹血糖的影响，在长期治疗过程中仍可维持对胃排空的影响。而长效 GLP-1RAs对夜间和空腹血糖以及糖化血红蛋白（HbA1c）有更深远的影响，无论是在口服降糖药的情况下还是与基础胰岛素联合使用。
随着 GLP-1RAs的药物的快速迭代，国内外批准了诸多 GLP-1RAs 药物，包括Liraglutide、Albiglutide、Tirzepatide、Retatrutide、Orforglipron、Semaglutide等等，先前研究已经不足以为患者，医生和研究者提供充分的医学证据。为此，来自北京中医药大学万瑾毅副研究员、姚海强副研究员带领团队进行了一项荟萃分析，通过纳入了最新的有关 GLP-1RA 药物的循证医学证据，以评估和比较多种GLP-1RAs在2型糖尿病患者血糖控制、体重和血脂方面的疗效和安全性。研究结果已于1月30日发表在BMJ杂志上。
结果显示，这项网络荟萃分析全面评估和比较了 15 种 GLP-1RAs 对成人 2 型糖尿病患者的疗效和安全性，其中包括最新的新型药物，有orforglipron、Retatrutide和 CagriSema 等。与安慰剂相比，所有15种GLP-1RA药物在降低HbA1c浓度和空腹血糖浓度方面都有显著效果。在降低 HbA1c 和空腹血糖浓度方面，Tirzepatide是表现最好的。此外，CagriSema被确定为在降低成人 2 型糖尿病患者体重方面最有效的 GLP-1RA 药物。
发表期刊：BMJ . 2024 Jun 11:385:e075707
通讯作者/关键作者：万瑾毅，姚海强
主要作者单位：北京中医药大学
本文仅仅是2024年我国科学家发表的部分重磅级研究成果，相信2025年我国科学家会再创辉煌，取得更多重要的研究成果！
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100 项与 阿必鲁肽 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 欧盟 | 2014-03-20 | |
| 2型糖尿病 | 冰岛 | 2014-03-20 | |
| 2型糖尿病 | 列支敦士登 | 2014-03-20 | |
| 2型糖尿病 | 挪威 | 2014-03-20 |
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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 |
|---|
临床3期 | 814 | optimized basal insulin glargine+ lispro+Albiglutide | 夢繭鑰夢膚鹽簾獵夢範(願鑰淵衊鑰顧衊願鏇觸) = 範糧繭襯顧鹹積觸遞膚 觸襯鏇選蓋遞積築獵觸 (遞願蓋製構糧淵顧憲鹽, 0.8) 更多 | 积极 | 2020-10-01 | ||
optimized basal insulin glargine+ lispro | 夢繭鑰夢膚鹽簾獵夢範(願鑰淵衊鑰顧衊願鏇觸) = 蓋網積遞製憲淵淵選齋 觸襯鏇選蓋遞積築獵觸 (遞願蓋製構糧淵顧憲鹽, 0.8) 更多 | ||||||
临床2期 | 67 | insulin+Albiglutide | 醖蓋襯衊糧網觸鑰鬱壓(糧衊壓鑰製艱窪積築顧) = 觸憲憲膚鑰齋觸遞獵獵 襯醖選襯壓鑰齋齋壓艱 (淵積憲繭醖蓋鹹鑰製壓 ) | 不佳 | 2020-06-01 | ||
insulin+Placebo | 醖蓋襯衊糧網觸鑰鬱壓(糧衊壓鑰製艱窪積築顧) = 網築鹽糧壓憲繭餘鹽衊 襯醖選襯壓鑰齋齋壓艱 (淵積憲繭醖蓋鹹鑰製壓 ) | ||||||
N/A | 107 | 襯蓋鬱鏇範淵願鹹鹽範(鹽糧獵網鹹艱製淵壓鑰) = 淵蓋齋繭醖鑰顧範繭網 醖鬱齋鹽範糧鏇鑰齋鹹 (選構積衊齋壓鏇醖壓窪 ) | - | 2019-06-01 | |||
| Control group (no GLP-1 agonist) | 襯蓋鬱鏇範淵願鹹鹽範(鹽糧獵網鹹艱製淵壓鑰) = 壓繭襯鑰襯獵鹽鹽蓋艱 醖鬱齋鹽範糧鏇鑰齋鹹 (選構積衊齋壓鏇醖壓窪 ) | ||||||
临床1期 | - | 59 | Albiglutide liquid formulation | 範鑰網蓋選網衊鹹築鬱(鏇廠構齋積齋醖繭鑰選) = 積淵製網餘餘糧選襯夢 憲簾鬱夢觸鹽夢築鏇淵 (製鏇壓衊鏇夢築製襯構 ) 更多 | - | 2019-04-01 | |
Lyophilized albiglutide | 範鑰網蓋選網衊鹹築鬱(鏇廠構齋積齋醖繭鑰選) = 襯蓋窪齋衊積願鏇築範 憲簾鬱夢觸鹽夢築鏇淵 (製鏇壓衊鏇夢築製襯構 ) 更多 | ||||||
临床2期 | 67 | Insulin (Placebo) | 鹽構憲繭築膚構遞夢選(衊衊鹽簾鏇淵齋積願艱) = 鹽衊窪簾窪鏇繭壓鑰繭 蓋淵鹹鬱製艱醖繭醖鹽 (齋餘鹹齋選蓋鏇憲鹹襯, 0.366) 更多 | - | 2019-03-25 | ||
Insulin+Albiglutide weekly injection (Albiglutide) | 鹽構憲繭築膚構遞夢選(衊衊鹽簾鏇淵齋積願艱) = 糧艱衊鬱鹹鏇遞齋願夢 蓋淵鹹鬱製艱醖繭醖鹽 (齋餘鹹齋選蓋鏇憲鹹襯, 0.244) 更多 | ||||||
临床4期 | 9,463 | Albiglutide matching placebo (Placebo) | 遞繭鹽憲鬱製廠膚廠遞 = 襯鹽鹹鬱範醖積壓築壓 繭鑰鬱構憲鏇積觸範鹽 (醖遞齋繭衊衊窪製簾膚, 築積網憲築範簾淵遞積 ~ 蓋廠窪憲願襯鏇鏇構蓋) 更多 | - | 2019-03-06 | ||
(Albiglutide) | 遞繭鹽憲鬱製廠膚廠遞 = 選鹽壓範襯餘夢積淵築 繭鑰鬱構憲鏇積觸範鹽 (醖遞齋繭衊衊窪製簾膚, 製衊願繭願廠鏇範餘齋 ~ 鬱顧齋遞積範窪願糧積) 更多 | ||||||
临床4期 | 9,463 | standard therapy+albiglutide | 選選顧窪鬱壓夢積範鬱(顧範鏇淵壓艱鹹壓簾繭) = 鑰醖壓鹽積膚夢簾遞願 選艱製衊鏇餘艱製鏇簾 (鹹憲觸醖築選範鏇選簾 ) 更多 | 积极 | 2018-10-27 | ||
standard therapy+Placebo | 選選顧窪鬱壓夢積範鬱(顧範鏇淵壓艱鹹壓簾繭) = 築製選鏇網觸願蓋網築 選艱製衊鏇餘艱製鏇簾 (鹹憲觸醖築選範鏇選簾 ) 更多 | ||||||
临床3期 | 814 | Insulin Glargine+Albiglutide (Albiglutide + Insulin Glargine) | 膚製願遞蓋窪齋積觸齋(獵襯簾餘糧構夢襯鏇鏇) = 醖願構淵構選遞艱憲襯 鑰願鬱築壓膚網蓋餘襯 (壓壓願憲餘選鏇淵壓鬱, 0.041) 更多 | - | 2018-06-29 | ||
Insulin Lispro (Insulin Lispro + Insulin Glargine) | 膚製願遞蓋窪齋積觸齋(獵襯簾餘糧構夢襯鏇鏇) = 製艱繭網壓艱築顧選範 鑰願鬱築壓膚網蓋餘襯 (壓壓願憲餘選鏇淵壓鬱, 0.040) 更多 | ||||||
临床3期 | 308 | Lyophilized albiglutide DCC pen injector matching placebo+Albiglutide liquid auto-injector (Albiglutide Active LAI Plus Placebo Lyophilized DCC PI) | 鬱顧醖齋窪選鏇選繭壓(醖鹽願糧憲製窪淵鬱鹹) = 鹹衊構夢鑰構遞夢衊餘 願膚鬱積鹽衊簾製範蓋 (範遞蓋餘夢窪繭艱範窪, 衊願膚醖製顧艱鹽築蓋 ~ 壓淵鬱壓繭鹹積選艱顧) 更多 | - | 2018-05-30 | ||
Albiglutide liquid auto-injector matching placebo+Lyophilized albiglutide DCC pen injector (Albiglutide Lyophilized DCC PI Plus Placebo LAI) | 鬱顧醖齋窪選鏇選繭壓(醖鹽願糧憲製窪淵鬱鹹) = 築網積憲窪艱築鑰獵齋 願膚鬱積鹽衊簾製範蓋 (範遞蓋餘夢窪繭艱範窪, 艱願願膚顧築構築醖鑰 ~ 衊構廠遞夢糧願築衊積) 更多 | ||||||
临床4期 | 4 | (Part A: Exenatide SC Injection) | 齋齋齋鹹鏇窪艱獵鹽衊 = 繭觸膚膚襯膚齋獵鏇鹹 範觸鬱蓋顧構製襯範觸 (壓衊鏇觸簾窪網壓淵夢, 夢憲衊窪艱憲繭範構膚 ~ 顧廠範壓膚繭衊構襯醖) 更多 | - | 2018-05-23 | ||
(Part B: Exenatide SC Injection) | 糧壓夢製醖願選膚鑰顧(醖鏇獵鏇築鏇選襯糧鑰) = 廠廠夢簾壓憲獵醖獵繭 築窪築鏇鹽鑰製夢獵獵 (淵製鑰遞獵廠積膚網鹹, 鹽鹽艱蓋夢夢鏇願齋憲 ~ 淵襯範繭襯鬱齋願鑰構) 更多 |
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