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Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone - a FIDELITY analysis. 2 型糖尿病和慢性肾病患者的低钾血症:非诺酮的影响 - FIDELITY 分析。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-08 DOI: 10.1093/ehjcvp/pvae074
Bertram Pitt, Rajiv Agarwal, Stefan D Anker, Peter Rossing, Luis Ruilope, Charles A Herzog, Barry Greenberg, Roberto Pecoits-Filho, Marc Lambelet, Robert Lawatscheck, Andrea Scalise, Gerasimos Filippatos

Aims: Hypokalaemia is associated with cardiovascular events and mortality in patients with chronic kidney disease (CKD). This exploratory FIDELITY analysis, a prespecified pooled patient-dataset from FIDELIO-DKD and FIGARO-DKD, investigated the incidence and effect of hypokalaemia in patients with CKD and type 2 diabetes (T2D) treated with finerenone vs. placebo.

Methods: Outcomes include the incidence of treatment-emergent hypokalaemia (serum potassium < 4.0 or < 3.5 mmol/L) and the effect of finerenone on cardiovascular composite outcome (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure) and arrhythmia composite outcome (new diagnosis of atrial fibrillation/atrial flutter, hospitalization due to arrhythmia, or sudden cardiac death) by baseline serum potassium subgroups.

Results: In the FIDELITY population, treatment-emergent hypokalaemia with serum potassium < 4.0 and < 3.5 mmol/L occurred in 41.1% and 7.5%, respectively. Hazards of cardiovascular and arrhythmia composite outcomes were higher in patients with baseline serum potassium < 4.0 vs. 4.0-4.5 mmol/L (hazard ratio [HR] 1.16; 95% confidence interval [CI] 1.02-1.32, P = 0.022 and HR 1.20; 95% CI 1.00-1.44, P = 0.055, respectively). Finerenone reduced the incidence of hypokalaemia with serum potassium < 4.0 mmol/L (HR 0.63; 95% CI 0.60-0.66) and < 3.5 mmol/L (HR 0.46; 95% CI 0.40-0.53) vs. placebo. Finerenone lessened the hazard of cardiovascular and arrhythmia events vs. placebo, irrespective of baseline serum potassium.

Conclusion: A substantial proportion of patients with CKD and T2D experienced hypokalaemia, which was associated with an increased hazard of adverse cardiovascular outcomes. Finerenone reduced the incidence of hypokalaemia. Finerenone reduced the hazard of cardiovascular and arrhythmia outcomes irrespective of serum potassium subgroups. Clinical trials registration: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).

目的:低钾血症与慢性肾脏病 (CKD) 患者的心血管事件和死亡率有关。这项探索性 FIDELITY 分析是一项来自 FIDELIO-DKD 和 FIGARO-DKD 的预设集合患者数据集,研究了接受非格列酮与安慰剂治疗的 CKD 和 2 型糖尿病(T2D)患者低钾血症的发生率及其影响:结果包括治疗引发的低血钾(血清钾结果)的发生率:结果:在 FIDELITY 研究人群中,治疗引发的低血钾(血清钾)发生率较高:相当一部分慢性肾脏病和终末期糖尿病患者出现低钾血症,这与不良心血管后果的风险增加有关。非格列酮能降低低钾血症的发生率。无论血清钾分组如何,非奈酮都能降低心血管和心律失常的危害。临床试验注册:FIDELIO-DKD 和 FIGARO-DKD 已在 ClinicalTrials.gov 注册,编号分别为 NCT02540993 和 NCT02545049(由拜耳公司资助)。
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引用次数: 0
The impact of sodium-glucose cotransporter 2 inhibitors in post-myocardial infarction management: insights from EMPACT-MI and DAPA-MI trials. SGLT2 抑制剂对心肌梗死后管理的影响:来自 EMPACT-MI 和 DAPA-MI 试验的启示。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae053
Eri Toda Kato, Koji Hasegawa, Koh Ono
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引用次数: 0
New ways of mitigating aldosterone in cardiorenal disease. 减轻心肾疾病中醛固酮的新方法。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae049
Felix Götzinger, Michael Kunz, Lucas Lauder, Michael Böhm, Felix Mahfoud

Steroidal mineralocorticoid receptor antagonists (MRAs) bind to the mineralocorticoid receptor and antagonize the effects of aldosterone, which contributes to the development and progression of cardio- and renovascular diseases. Guidelines recommend steroidal MRAs in patients with heart failure with reduced or mildly reduced ejection fraction, as they reduce morbidity and mortality. In heart failure with preserved ejection fraction, MRAs have not convincingly shown to improve prognosis. Steroidal MRAs delay the progression of chronic kidney disease, reduce proteinuria and lower blood pressure in resistant hypertension but can induce hyperkalaemia. Due to their limited selectivity to the mineralocorticoid receptor, steroidal MRAs can cause significant adverse effects, i.e. libido loss, erectile dysfunction, gynaecomastia, and amenorrhoea, leading to low rates of persistance. Against this background, new avenues for developing non-steroidal, selective (ns)MRAs and aldosterone-synthase inhibitors have been taken. Finerenone has been shown to delay the progression of diabetic nephropathy and lower the incidence of heart failure hospitalizations in patients with chronic kidney disease and diabetes compared with placebo. Finerenone has therefore been recommended by the 2023 European Society of Cardiology Guidelines for the management of diabetes in patients with type 2 diabetes and chronic kidney disease. Further randomized controlled trials assessing the safety and effectiveness of finerenone in patients with heart failure are currently ongoing. Esaxerenone provides antihypertensive effects and has been approved for the treatment of hypertension in Japan. Baxdrostat and lorundostat, novel selective aldosterone-synthase inhibitors, are currently under investigation. In phase II trials, baxdrostat and lorundostat were safe and effective in lowering blood pressure in resistant hypertension. In this review, we summarize and critically discuss the evidence for new drugs mitigating aldosterone in heart failure, hypertension, and chronic kidney disease.

类固醇类矿化皮质激素受体拮抗剂(MRA)与矿化皮质激素受体结合,拮抗醛固酮的作用,而醛固酮会导致心脑血管疾病的发生和发展。对于射血分数降低或轻度降低的心力衰竭患者,指南推荐使用类固醇 MRA,因为它们可以降低发病率和死亡率。对于射血分数保留的心衰患者,MRA 并未令人信服地改善预后。类固醇类 MRA 可延缓慢性肾病的进展,减少蛋白尿,降低抵抗性高血压患者的血压,但会诱发高钾血症。由于类固醇 MRA 对矿物质皮质激素受体的选择性有限,它们可能会引起明显的不良反应,如性欲减退、勃起功能障碍、妇科肿瘤和闭经,导致持续用药率低。在此背景下,开发非甾体、选择性(ns)MRA 和醛固酮合成酶抑制剂的新途径应运而生。与安慰剂相比,非格列酮能延缓糖尿病肾病的进展,降低慢性肾病和糖尿病患者心力衰竭的住院率。因此,《2023 年欧洲心脏病学会指南》推荐使用非格列酮来治疗 2 型糖尿病和慢性肾病患者的糖尿病。目前正在进行进一步的随机对照试验,评估非奈瑞酮对心力衰竭患者的安全性和有效性。依沙萘酮具有降压作用,在日本已被批准用于治疗高血压。目前正在研究新型选择性醛固酮合成酶抑制剂 Baxdrostat 和 lorundostat。在 II 期试验中,Baxdrostat 和 Lorundostat 在降低抵抗性高血压患者的血压方面安全有效。在这篇综述中,我们总结并认真讨论了减轻心力衰竭、高血压和慢性肾病患者醛固酮的新药证据。
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引用次数: 0
The dual endothelin-1 antagonist aprocitentan alleviates mitochondrial oxidative stress in human cardiac fibroblasts. 双重内皮素-1 拮抗剂阿普西坦能缓解人心脏成纤维细胞的线粒体氧化应激
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae050
Fahimeh Varzideh, Stanislovas S Jankauskas, Urja Jain, Lauren Soderquist, Esther Densu Agyapong, Urna Kansakar, Gaetano Santulli
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引用次数: 0
Diltiazem reduces levels of NT-proBNP and improves symptoms compared with metoprolol in patients with permanent atrial fibrillation. 与美托洛尔相比,地尔硫卓能降低永久性心房颤动患者的 NT-proBNP 水平并改善症状。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae032
Katrine Enge, Arnljot Tveit, Steve Enger, Sophia Onarheim, Are Hugo Pripp, Peter Selmer Rønningen, Magnar Gangås Solberg, Rune Byrkjeland, Kristoffer Andresen, Anders Halsen, Hanne Aaserud Aulie, Trude Steinsvik, Christian Hall, Sara Reinvik Ulimoen

Aims: Short-term treatment with calcium channel blockers lowers levels of N-terminal pro B-type natriuretic peptide (NT-proBNP) and reduces rhythm-related symptoms compared to treatment with beta-blockers. The aim of this study was to compare the effects of metoprolol and diltiazem for rate control in patients with permanent atrial fibrillation (AF) after 6 months.

Methods and results: Men and women with permanent AF and preserved left ventricular systolic function were randomized to receive either diltiazem 360 mg or metoprolol 100 mg once daily. The primary endpoint was the level of NT-proBNP after a 6-month treatment period. Secondary endpoints included heart rate, rhythm-related symptoms and exercise capacity. A total of 93 patients (mean age 71 ± 7 years, 28 women) were randomized. After 6-months' treatment, mean levels of NT-proBNP decreased in the diltiazem group and increased in the metoprolol group, with a significant between-group difference (409.8 pg/mL, 95% CI: 230.6-589.1, P < 0.001). Treatment with diltiazem significantly reduced rhythm-related symptoms compared to baseline, but no change was observed in the metoprolol group. Diltiazem and metoprolol had similar effects on heart rate and exercise capacity.

Conclusion: Diltiazem reduced NT-proBNP levels and improved rhythm-related symptoms. Metoprolol increased peptide levels but had no impact on symptoms despite similar heart rate reduction. Non-dihydropyridine calcium channel blockers should be considered more often for rate control in permanent AF.

目的:与β-受体阻滞剂相比,钙通道阻滞剂的短期治疗可降低N-末端前B型钠尿肽(NT-proBNP)的水平并减轻心律相关症状。本研究旨在比较美托洛尔和地尔硫卓在 6 个月后对永久性心房颤动患者进行心率控制的长期效果:对患有永久性心房颤动且左心室收缩功能保留的男性和女性患者进行随机分组,分别给予地尔硫卓 360 毫克或美托洛尔 100 毫克,每天一次。主要终点是治疗 6 个月后的 NT-proBNP 水平。次要终点包括心率、心律相关症状和运动能力。共有 93 名患者(平均年龄 71 ± 7 岁,28 名女性)接受了随机治疗。经过 6 个月的治疗,地尔硫卓组的 NT-proBNP 平均水平有所下降,而美托洛尔组则有所上升,组间差异显著(409.8 pg/mL,95% CI:230.6 - 589.1,PC结论:地尔硫卓降低了NT-proBNP水平,改善了心律相关症状。美托洛尔能提高肽水平,但对症状没有影响,尽管心率降低的情况相似。在控制永久性心房颤动的心率时,应更多地考虑使用非二氢吡啶类钙通道阻滞剂。
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引用次数: 0
Comparative effects of different antiplatelet strategies in carriers of CYP2C19 loss-of-function alleles: a network meta-analysis. 不同抗血小板策略对 CYP2C19 功能缺失等位基因携带者的比较效应:一项网络荟萃分析。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae036
Mattia Galli, Giovanni Occhipinti, Stefano Benenati, Renzo Laborante, Luis Ortega-Paz, Francesco Franchi, Domenico D'Amario, Roberto Nerla, Fausto Castriota, Giacomo Frati, Giuseppe Biondi-Zoccai, Sebastiano Sciarretta, Dominick J Angiolillo

Background: Carriers of cytochrome 2C19 (CYP2C19) loss-of-function (LoF) alleles treated with clopidogrel have impaired drug metabolism, resulting in reduced active metabolite levels, high platelet reactivity (HPR), and an increased risk of thrombotic events. Several alternative antiplatelet therapies have been proposed to overcome HPR in these patients, but their comparative effects remain poorly explored.

Methods: Randomized controlled trials (RCTs) comparing different oral antiplatelet therapies in carriers of CYP2C19 LoF alleles undergoing percutaneous coronary interventions (PCI) were included. A frequentist network meta-analysis was conducted to estimate mean difference (MD) or odds ratios and 95% confidence intervals (CI). The primary outcome was platelet reactivity assessed by VerifyNow and reported as P2Y12 reaction unit (PRU). The secondary outcome was the rate of HPR. Standard dose of clopidogrel (75 mg daily) was used as a reference treatment.

Results: A total of 12 RCTs testing 6 alternative strategies (i.e. clopidogrel 150 mg, prasugrel 3.75 mg, 5 mg, and 10 mg, ticagrelor 90 mg bid, and adjunctive cilostazol 100 mg bid) were included in the network. Compared with standard-dose clopidogrel, the greatest reduction in PRU was observed with prasugrel 10 mg (MD -127.91; 95% CI -141.04; -114.78) and ticagrelor 90 mg bid (MD -124.91; 95% CI -161.78; -88.04), followed by prasugrel 5 mg (MD -76.33; 95% CI -98.01; -54.65) and prasugrel 3.75 mg (MD -73.00; 95% CI -100.28; -45.72). Among other strategies, adjunctive cilostazol (MD -42.64; 95% CI -64.72; -20.57) and high-dose clopidogrel (MD -32.11; 95% CI -51.33; -12.90) were associated with a modest reduction in PRU compared with standard-dose clopidogrel.

Conclusion: Among carriers of CYP2C19 LoF alleles undergoing PCI, standard-dose prasugrel or ticagrelor are most effective in reducing platelet reactivity, while double-dose clopidogrel and additional cilostazol showed modest effects. Reduced-dose of prasugrel may represent a balanced strategy to overcome HPR without a significant increase in bleeding. The clinical implications of these pharmacodynamic findings warrant further investigation.

背景:细胞色素 2C19(CYP2C19)功能缺失(LoF)等位基因携带者在使用氯吡格雷治疗时,药物代谢会受损,导致活性代谢物水平降低、血小板反应性高(HPR)以及血栓事件风险增加。目前已提出了几种替代抗血小板疗法来克服这些患者的高血小板反应性,但对它们的比较效果仍缺乏深入探讨:方法:纳入了在接受经皮冠状动脉介入治疗(PCI)的 CYP2C19 LoF 等位基因携带者中比较不同口服抗血小板疗法的随机对照试验(RCT)。进行了频数网络荟萃分析,以估计平均差(MD)或几率比(OR)和95%置信区间(CI)。主要结果是由 VerifyNow 评估的血小板反应性,并以 P2Y12 反应单位 (PRU) 报告。次要结果是 HPR 发生率。标准剂量的氯吡格雷(每天 75 毫克)作为参考治疗:该网络共纳入了 12 项 RCT,测试了 6 种替代策略(即氯吡格雷 150 毫克、普拉格雷 3.75 毫克、5 毫克和 10 毫克、替卡格雷 90 毫克 bid 和辅助西洛他唑 100 毫克 bid)。与标准剂量氯吡格雷相比,普拉格雷 10 mg(MD -127.91; 95% CI -141.04; -114.78)和替卡格雷 90 mg bid(MD -124.91;95% CI -161.78;-88.04),其次是普拉格雷 5 毫克(MD -76.33;95% CI -98.01;-54.65)和普拉格雷 3.75 毫克(MD -73.00;95% CI -100.28;-45.72)。在其他策略中,与标准剂量氯吡格雷相比,辅助西洛他唑(MD-42.64;95% CI -64.72;-20.57)和大剂量氯吡格雷(MD -32.11;95% CI -51.33;-12.90)与PRU的适度降低有关:结论:在接受PCI治疗的CYP2C19 LoF等位基因携带者中,标准剂量的普拉格雷或替卡格雷能最有效地降低血小板反应性,而双倍剂量的氯吡格雷和额外的西洛他唑效果一般。减少剂量的普拉格雷可能是克服 HPR 的一种平衡策略,同时不会显著增加出血量。这些药效学发现的临床意义值得进一步研究。
{"title":"Comparative effects of different antiplatelet strategies in carriers of CYP2C19 loss-of-function alleles: a network meta-analysis.","authors":"Mattia Galli, Giovanni Occhipinti, Stefano Benenati, Renzo Laborante, Luis Ortega-Paz, Francesco Franchi, Domenico D'Amario, Roberto Nerla, Fausto Castriota, Giacomo Frati, Giuseppe Biondi-Zoccai, Sebastiano Sciarretta, Dominick J Angiolillo","doi":"10.1093/ehjcvp/pvae036","DOIUrl":"10.1093/ehjcvp/pvae036","url":null,"abstract":"<p><strong>Background: </strong>Carriers of cytochrome 2C19 (CYP2C19) loss-of-function (LoF) alleles treated with clopidogrel have impaired drug metabolism, resulting in reduced active metabolite levels, high platelet reactivity (HPR), and an increased risk of thrombotic events. Several alternative antiplatelet therapies have been proposed to overcome HPR in these patients, but their comparative effects remain poorly explored.</p><p><strong>Methods: </strong>Randomized controlled trials (RCTs) comparing different oral antiplatelet therapies in carriers of CYP2C19 LoF alleles undergoing percutaneous coronary interventions (PCI) were included. A frequentist network meta-analysis was conducted to estimate mean difference (MD) or odds ratios and 95% confidence intervals (CI). The primary outcome was platelet reactivity assessed by VerifyNow and reported as P2Y12 reaction unit (PRU). The secondary outcome was the rate of HPR. Standard dose of clopidogrel (75 mg daily) was used as a reference treatment.</p><p><strong>Results: </strong>A total of 12 RCTs testing 6 alternative strategies (i.e. clopidogrel 150 mg, prasugrel 3.75 mg, 5 mg, and 10 mg, ticagrelor 90 mg bid, and adjunctive cilostazol 100 mg bid) were included in the network. Compared with standard-dose clopidogrel, the greatest reduction in PRU was observed with prasugrel 10 mg (MD -127.91; 95% CI -141.04; -114.78) and ticagrelor 90 mg bid (MD -124.91; 95% CI -161.78; -88.04), followed by prasugrel 5 mg (MD -76.33; 95% CI -98.01; -54.65) and prasugrel 3.75 mg (MD -73.00; 95% CI -100.28; -45.72). Among other strategies, adjunctive cilostazol (MD -42.64; 95% CI -64.72; -20.57) and high-dose clopidogrel (MD -32.11; 95% CI -51.33; -12.90) were associated with a modest reduction in PRU compared with standard-dose clopidogrel.</p><p><strong>Conclusion: </strong>Among carriers of CYP2C19 LoF alleles undergoing PCI, standard-dose prasugrel or ticagrelor are most effective in reducing platelet reactivity, while double-dose clopidogrel and additional cilostazol showed modest effects. Reduced-dose of prasugrel may represent a balanced strategy to overcome HPR without a significant increase in bleeding. The clinical implications of these pharmacodynamic findings warrant further investigation.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140956801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CYP2C19 genetic testing for Mavacamten and ischaemic stroke treatment: What does the result mean for cardiovascular prescribers in the UK and Europe? 针对马伐康坦和缺血性中风治疗的 CYP2C19 基因检测:该结果对英国和欧洲的心血管处方者意味着什么?
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae040
Emma F Magavern, John H McDermott, Mark J Caulfield, William G Newman
{"title":"CYP2C19 genetic testing for Mavacamten and ischaemic stroke treatment: What does the result mean for cardiovascular prescribers in the UK and Europe?","authors":"Emma F Magavern, John H McDermott, Mark J Caulfield, William G Newman","doi":"10.1093/ehjcvp/pvae040","DOIUrl":"10.1093/ehjcvp/pvae040","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
All about clinical trials. 关于临床试验
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae055
Anne Grete Semb, Julie Sanders, Juan Carlos Kaski
{"title":"All about clinical trials.","authors":"Anne Grete Semb, Julie Sanders, Juan Carlos Kaski","doi":"10.1093/ehjcvp/pvae055","DOIUrl":"10.1093/ehjcvp/pvae055","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacological management of transthyretin amyloid cardiomyopathy: a scoping review. 转甲状腺素淀粉样变性心肌病的药物治疗:范围综述。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae044
Shafi Rehman, Shameera Shaik Masthan, Ramzi Ibrahim, Hoang Nhat Pham, Danial Hassan, Fahad Ahmad, Mohammad Shahzad Asif, Ahmad Safdar, Zain Anwar, Shahzad Raza, Preethi William

Aims: Transthyretin amyloid cardiomyopathy (ATTR-CM) is characterized by the accumulation of transthyretin (TTR) protein in the myocardium. The aim of this scoping review is to provide a descriptive summary of the clinical trials and observational studies that evaluated the clinical efficacy and safety of various agents used in ATTR-CM, with a goal of identifying the contemporary gaps in literature and to reveal future research opportunities.

Methods and results: The search was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A literature search using several databases for observational and clinical trials investigating the treatment modalities for ATTR-CM was undertaken. We extracted data including study characteristics, primary endpoints, and adverse events from each study. A total of 19 studies were included in our scoping review. Out of which, 8 were clinical trials and 11 were observational analyses. The drugs evaluated included tafamadis, acoramidis, revusiran, doxycycline and tauroursodeoxycholic acid and doxycycline, diflusinil, inotersan, eplontersen, and patisiran. Tafamidis has shown to be efficacious in the management of ATTR-CM, particularly when initiated at earlier stages. RNA interference and antisense oligonucleotide drugs have shown promising impacts on quality of life. Additionally, this review identified gaps in the literature, particularly among long-term outcomes, comparative effectiveness, and the translation of research into economic contexts.

Conclusion: Multiple pharmacological options are potential disease-modifying therapies for ATTR-CM. However, many gaps exist in the understanding of these various drug therapies, warranting further research. The future directions for management of ATTR-CM are promising in regard to improving prognostic implications.

目的:转甲状腺素淀粉样变性心肌病(ATTR-CM)的特征是转甲状腺素(TTR)蛋白在心肌中的蓄积。本范围综述旨在对评估用于 ATTR-CM 的各种药物的临床疗效和安全性的临床试验和观察性研究进行描述性总结,目的是找出文献中的当代空白,并揭示未来的研究机会:检索按照《系统综述和元分析首选报告项目》(PRISMA)指南进行。我们使用多个数据库对研究 ATTR-CM 治疗方法的观察性和临床试验进行了文献检索。我们从每项研究中提取了包括研究特征、主要终点和不良事件在内的数据。共有 19 项研究纳入了我们的范围界定审查。其中 8 项为临床试验,11 项为观察性分析。接受评估的药物包括他法米迪、阿可拉米迪、雷夫西兰、TUDCA 和强力霉素、地氟西尼、依诺他桑、依普隆特生和帕替西兰。他法米迪对治疗 ATTR-CM 有一定疗效,尤其是在早期阶段。RNA 干扰和反义寡核苷酸药物已显示出对生活质量的良好影响。此外,本综述还发现了文献中的不足之处,尤其是在长期疗效、比较效果以及将研究成果转化为经济效益方面:结论:多种药物选择是治疗 ATTR-CM 的潜在疾病改变疗法。结论:多种药物疗法是治疗 ATTR-CM 的潜在疾病改变疗法,但对这些不同药物疗法的认识还存在许多差距,需要进一步研究。未来 ATTR-CM 的治疗方向有望改善预后影响。
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引用次数: 0
Association of PCSK9 inhibitors with mortality: insights from a retrospective cohort analysis. PCSK9 抑制剂与死亡率的关系:回顾性队列分析的启示。
IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-04 DOI: 10.1093/ehjcvp/pvae056
Chi-Hsien Huang, Shiow-Ing Wang, Frank S Fan, Hsueh-Ju Lu, James Cheng-Chung Wei

Aims: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective in reducing cardiovascular events, but their impact on all-cause mortality and medical utilization compared to statins is unclear. This study investigated PCSK9 inhibitor use and its impact on mortality and medical utilization vs. statins, using TriNetX database data with up to 9 years of follow-up.

Methods and results: This retrospective cohort study analysed TriNetX data spanning 1 July 2015, to 31 December 2023, including 79 194 PCSK9 inhibitor users (alirocumab, evolocumab, inclisiran) and 5 437 513 statin users with hyperlipidaemia. The primary outcomes were all-cause mortality and medical utilization, including hospital inpatient services, emergency department visits, critical care, and mechanical ventilation. Propensity score matching showed that PCSK9 inhibitor use was associated with a 28.3% lower risk of all-cause mortality [adjusted hazard ratio (aHR) 0.717, 95% confidence interval (CI): 0.673-0.763] and significant reductions in medical utilization (hospital inpatient services usage: aHR 0.692, 95% CI: 0.664-0.721; emergency department services: aHR 0.756, 95% CI: 0.726-0.788; critical care services: aHR 0.619, 95% CI: 0.578-0.664; and mechanical ventilation: aHR 0.537, 95% CI: 0.484-0.596) compared to statins. These findings were consistent across various demographics and clinical subgroups. The sensitivity analyses supported the robustness of the findings.

Conclusion: PCSK9 inhibitors significantly reduced all-cause mortality and medical utilization compared to statins, suggesting their important role in dyslipidaemia management, particularly for statin-naïve or intolerant patients. Further research, including randomized controlled trials, is needed to confirm these findings and explore the underlying mechanisms.

背景和目的:PCSK9 抑制剂可有效减少心血管事件,但与他汀类药物相比,其对全因死亡率和医疗利用率的影响尚不明确。本研究利用随访长达 9 年的 TriNetX 数据库数据,调查了 PCSK9 抑制剂的使用情况及其对死亡率和医疗利用率的影响:这项回顾性队列研究分析了2015年7月1日至2023年12月31日的TriNetX数据,其中包括79 194名PCSK9抑制剂使用者(阿利珠单抗、依维莫单抗、clisiran)和5 437 513名他汀类药物高脂血症使用者。主要结果是全因死亡率和医疗使用率,包括住院服务、急诊就诊、重症监护和机械通气。倾向得分匹配显示,使用 PCSK9 抑制剂可使全因死亡风险降低 28.3%(调整后危险比 [aHR] 0.717,95% CI:0.673-0.763),并显著降低医疗使用率(住院病人服务使用率:aHR 0.692,95% CI:0.664-0.721;急诊科服务:aHR 0.756,95% CI:0.726-0.788;重症监护服务:aHR 0.619,95% CI:0.578-0.664;机械通气:aHR 0.537,95% CI:0.484-0.596)。这些结果在不同的人口统计学和临床亚组中是一致的。敏感性分析证实了研究结果的稳健性:结论:与他汀类药物相比,PCSK9抑制剂能明显降低全因死亡率和医疗使用率,这表明它在血脂异常管理中发挥着重要作用,尤其是对他汀类药物无效或不耐受的患者。需要进一步研究,包括随机对照试验,以证实这些发现并探索其潜在机制。
{"title":"Association of PCSK9 inhibitors with mortality: insights from a retrospective cohort analysis.","authors":"Chi-Hsien Huang, Shiow-Ing Wang, Frank S Fan, Hsueh-Ju Lu, James Cheng-Chung Wei","doi":"10.1093/ehjcvp/pvae056","DOIUrl":"10.1093/ehjcvp/pvae056","url":null,"abstract":"<p><strong>Aims: </strong>Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective in reducing cardiovascular events, but their impact on all-cause mortality and medical utilization compared to statins is unclear. This study investigated PCSK9 inhibitor use and its impact on mortality and medical utilization vs. statins, using TriNetX database data with up to 9 years of follow-up.</p><p><strong>Methods and results: </strong>This retrospective cohort study analysed TriNetX data spanning 1 July 2015, to 31 December 2023, including 79 194 PCSK9 inhibitor users (alirocumab, evolocumab, inclisiran) and 5 437 513 statin users with hyperlipidaemia. The primary outcomes were all-cause mortality and medical utilization, including hospital inpatient services, emergency department visits, critical care, and mechanical ventilation. Propensity score matching showed that PCSK9 inhibitor use was associated with a 28.3% lower risk of all-cause mortality [adjusted hazard ratio (aHR) 0.717, 95% confidence interval (CI): 0.673-0.763] and significant reductions in medical utilization (hospital inpatient services usage: aHR 0.692, 95% CI: 0.664-0.721; emergency department services: aHR 0.756, 95% CI: 0.726-0.788; critical care services: aHR 0.619, 95% CI: 0.578-0.664; and mechanical ventilation: aHR 0.537, 95% CI: 0.484-0.596) compared to statins. These findings were consistent across various demographics and clinical subgroups. The sensitivity analyses supported the robustness of the findings.</p><p><strong>Conclusion: </strong>PCSK9 inhibitors significantly reduced all-cause mortality and medical utilization compared to statins, suggesting their important role in dyslipidaemia management, particularly for statin-naïve or intolerant patients. Further research, including randomized controlled trials, is needed to confirm these findings and explore the underlying mechanisms.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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European Heart Journal - Cardiovascular Pharmacotherapy
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