Pub Date : 2025-08-25DOI: 10.1007/s40256-025-00760-x
Donna Shu-Han Lin, Hao-Yun Lo, Chung-Wei Yang, Chih-Cheng Wu
Aim
Our aim was to evaluate the safety of empagliflozin in escalating doses among patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis who also have heart failure.
Methods
This single-arm, open-label, dose-escalation study enrolled patients with ESRD on maintenance hemodialysis with heart failure (reduced or preserved ejection fraction) from June to September 2023. Patients sequentially received empagliflozin at doses of 5 mg, 10 mg, and 25 mg daily for 4 weeks per dose, alongside standard care. Pre-dialysis vital signs, electrocardiograms, complete blood counts, and biochemical profiles were monitored weekly. Dose-dependent changes were assessed using linear mixed models.
Results
A total of 17 patients participated, without significant adverse events. Empagliflozin treatment was associated with a significant shortening of QRS duration (regression coefficient − 3.35 ms, P < 0.001), stable QT intervals, increased serum calcium (regression coefficient 0.02 mg/dL, P = 0.004), and decreased bicarbonate levels (regression coefficient − 0.27 mmol/L, P = 0.019). Additionally, diastolic blood pressures measured pre-dialysis significantly increased over time (regression coefficient 1.70 mmHg, P = 0.025).
Conclusion
Empagliflozin at doses of 5 mg, 10 mg, and 25 mg per day, administered sequentially for 4 weeks each, demonstrated a favorable safety profile in patients with ESRD undergoing maintenance hemodialysis. Further studies are warranted to explore clinical implications of the observed physiological changes.
Registration
This was a single-arm, open-label, dose-escalating safety study required by the institutional review board of the National Taiwan University Hospital before the commencement of two randomized controlled trials registered at ClinicalTrials.gov (EMPA-PRED [NCT06249945] and EMPA-RRED [NCT06249932]).
目的：我们的目的是评估恩格列净在接受维持性血液透析并伴有心力衰竭的终末期肾病（ESRD）患者中剂量递增的安全性。方法：这项单臂、开放标签、剂量递增的研究纳入了2023年6月至9月接受维持性血液透析并心力衰竭（射血分数降低或保留）的ESRD患者。患者依次接受每日5mg、10mg和25mg剂量的恩格列净治疗，每剂量4周，同时接受标准治疗。每周监测透析前生命体征、心电图、全血细胞计数和生化指标。使用线性混合模型评估剂量依赖性变化。结果：共17例患者参与，无明显不良事件。恩格列净治疗与QRS持续时间显著缩短（回归系数为3.35 ms, P < 0.001）、QT间期稳定、血钙升高（回归系数为0.02 mg/dL, P = 0.004）、碳酸氢盐水平降低（回归系数为0.27 mmol/L, P = 0.019）相关。此外，透析前舒张压随时间显著升高（回归系数1.70 mmHg, P = 0.025）。结论：依帕列净剂量分别为5mg、10mg和25mg /天，连续给药4周，在进行维持性血液透析的ESRD患者中显示出良好的安全性。进一步的研究需要探索观察到的生理变化的临床意义。注册：这是一项单组、开放标签、剂量递增的安全性研究，在ClinicalTrials.gov注册的两项随机对照试验（EMPA-PRED [NCT06249945]和EMPA-RRED [NCT06249932]）开始之前，由国立台湾大学医院机构审查委员会要求进行。
{"title":"Safety and Short-Term Effects of Empagliflozin in Patients with Heart Failure and End-Stage Renal Disease","authors":"Donna Shu-Han Lin, Hao-Yun Lo, Chung-Wei Yang, Chih-Cheng Wu","doi":"10.1007/s40256-025-00760-x","DOIUrl":"10.1007/s40256-025-00760-x","url":null,"abstract":"<div><h3>Aim</h3><p>Our aim was to evaluate the safety of empagliflozin in escalating doses among patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis who also have heart failure.</p><h3>Methods</h3><p>This single-arm, open-label, dose-escalation study enrolled patients with ESRD on maintenance hemodialysis with heart failure (reduced or preserved ejection fraction) from June to September 2023. Patients sequentially received empagliflozin at doses of 5 mg, 10 mg, and 25 mg daily for 4 weeks per dose, alongside standard care. Pre-dialysis vital signs, electrocardiograms, complete blood counts, and biochemical profiles were monitored weekly. Dose-dependent changes were assessed using linear mixed models.</p><h3>Results</h3><p>A total of 17 patients participated, without significant adverse events. Empagliflozin treatment was associated with a significant shortening of QRS duration (regression coefficient − 3.35 ms, <i>P</i> < 0.001), stable QT intervals, increased serum calcium (regression coefficient 0.02 mg/dL, <i>P</i> = 0.004), and decreased bicarbonate levels (regression coefficient − 0.27 mmol/L, <i>P</i> = 0.019). Additionally, diastolic blood pressures measured pre-dialysis significantly increased over time (regression coefficient 1.70 mmHg, <i>P</i> = 0.025).</p><h3>Conclusion</h3><p>Empagliflozin at doses of 5 mg, 10 mg, and 25 mg per day, administered sequentially for 4 weeks each, demonstrated a favorable safety profile in patients with ESRD undergoing maintenance hemodialysis. Further studies are warranted to explore clinical implications of the observed physiological changes. </p><h3>Registration</h3><p>This was a single-arm, open-label, dose-escalating safety study required by the institutional review board of the National Taiwan University Hospital before the commencement of two randomized controlled trials registered at ClinicalTrials.gov (EMPA-PRED [NCT06249945] and EMPA-RRED [NCT06249932]).</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"26 1","pages":"83 - 96"},"PeriodicalIF":3.0,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emerging evidence suggests that sodium–glucose co-transporter-2 (SGLT2) inhibitors reduce cardiovascular events in patients with diabetes mellitus (DM) after acute myocardial infarction (AMI), but evidence in Asian populations remains limited.
Objective
We assessed the impact of SGLT2 inhibitors on in-hospital, 30-day, and 30-day to 1-year mortality in a Northern Chinese real-world cohort.
Methods
An electronic health record-based cohort was constructed from the Tianjin Health and Medical Data Platform from January 2013 to December 2022. Statistical analyses, including Kaplan–Meier survival analysis, multivariable regression analysis, and propensity score matching, were undertaken to evaluate the impact of SGLT2 inhibitors on in-hospital, 30-day, and 1-year mortality rates.
Results
A total of 23,486 patients with both AMI and DM were included. Patients treated with SGLT2 inhibitors (n = 5053) were younger (64.2 vs 67.2 years) and had a higher frequency of dyslipidemia (26.4% vs 18.5%) and history of percutaneous coronary intervention (17.1% vs 15.3%) than those who did not receive them. After multivariable adjustment, the use of SGLT2 inhibitors showed a lower mortality rate during hospitalization (odds ratio 0.44; 95% confidence interval [CI] 0.33–0.58), at 30 days (hazard ratio 0.44; 95% CI 0.36–0.53), and at 30 days to 1 year (hazard ratio 0.86; 95% CI 0.73–1.00). These findings were further supported by propensity score matching and subgroup analyses, which consistently confirmed the reduction in mortality across all three time points.
Conclusion
In a real-world electronic health record-based cohort in China, this study confirmed a mortality benefit with the use of SGLT2 inhibitors in patients with combined DM and AMI. Further studies are needed to validate these benefits across broader populations.
背景：新出现的证据表明，钠-葡萄糖共转运蛋白-2 （SGLT2）抑制剂可减少急性心肌梗死（AMI）后糖尿病（DM）患者的心血管事件，但在亚洲人群中的证据仍然有限。目的：我们评估SGLT2抑制剂对中国北方现实世界队列患者住院、30天、30天至1年死亡率的影响。方法：从2013年1月至2022年12月，从天津市卫生医疗数据平台构建基于电子健康档案的队列。统计分析，包括Kaplan-Meier生存分析、多变量回归分析和倾向评分匹配，评估SGLT2抑制剂对住院、30天和1年死亡率的影响。结果：共纳入AMI和DM患者23,486例。与未接受SGLT2抑制剂治疗的患者相比，接受SGLT2抑制剂治疗的患者（n = 5053）更年轻（64.2 vs 67.2岁），血脂异常的频率（26.4% vs 18.5%）和经皮冠状动脉介入治疗史（17.1% vs 15.3%）更高。多变量调整后，使用SGLT2抑制剂显示住院期间（优势比0.44；95%可信区间[CI] 0.33-0.58）、30天（风险比0.44;95% CI 0.36-0.53）和30天至1年（风险比0.86;95% CI 0.73-1.00）的死亡率较低。倾向评分匹配和亚组分析进一步支持了这些发现，一致证实了所有三个时间点的死亡率降低。结论：在中国一项基于电子健康记录的真实世界队列研究中，该研究证实在合并DM和AMI的患者中使用SGLT2抑制剂可降低死亡率。需要进一步的研究在更广泛的人群中验证这些益处。
{"title":"SGLT2 Inhibitors and Improved Survival in Patients with Diabetes and Acute Myocardial Infarction: Evidence from an Electronic Health Record-Based Cohort Study","authors":"Xuefang Yu, Liang Zhao, Hangkuan Liu, Xin Zhou, Guoyan Zhao, Zhiqiang Zhang, Xilong Qian, Bin Sun, Shiyang Fang, Qing Yang, Pengfei Sun","doi":"10.1007/s40256-025-00759-4","DOIUrl":"10.1007/s40256-025-00759-4","url":null,"abstract":"<div><h3>Background</h3><p>Emerging evidence suggests that sodium–glucose co-transporter-2 (SGLT2) inhibitors reduce cardiovascular events in patients with diabetes mellitus (DM) after acute myocardial infarction (AMI), but evidence in Asian populations remains limited.</p><h3>Objective</h3><p>We assessed the impact of SGLT2 inhibitors on in-hospital, 30-day, and 30-day to 1-year mortality in a Northern Chinese real-world cohort.</p><h3>Methods</h3><p>An electronic health record-based cohort was constructed from the Tianjin Health and Medical Data Platform from January 2013 to December 2022. Statistical analyses, including Kaplan–Meier survival analysis, multivariable regression analysis, and propensity score matching, were undertaken to evaluate the impact of SGLT2 inhibitors on in-hospital, 30-day, and 1-year mortality rates.</p><h3>Results</h3><p>A total of 23,486 patients with both AMI and DM were included. Patients treated with SGLT2 inhibitors (<i>n</i> = 5053) were younger (64.2 vs 67.2 years) and had a higher frequency of dyslipidemia (26.4% vs 18.5%) and history of percutaneous coronary intervention (17.1% vs 15.3%) than those who did not receive them. After multivariable adjustment, the use of SGLT2 inhibitors showed a lower mortality rate during hospitalization (odds ratio 0.44; 95% confidence interval [CI] 0.33–0.58), at 30 days (hazard ratio 0.44; 95% CI 0.36–0.53), and at 30 days to 1 year (hazard ratio 0.86; 95% CI 0.73–1.00). These findings were further supported by propensity score matching and subgroup analyses, which consistently confirmed the reduction in mortality across all three time points.</p><h3>Conclusion</h3><p>In a real-world electronic health record-based cohort in China, this study confirmed a mortality benefit with the use of SGLT2 inhibitors in patients with combined DM and AMI. Further studies are needed to validate these benefits across broader populations.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 6","pages":"841 - 850"},"PeriodicalIF":3.0,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-20DOI: 10.1007/s40256-025-00753-w
Stephen J. Nicholls, Kausik K. Ray, A. Michael Lincoff, Evelyn Sarnes, Kristin K. Gillard, LeAnne Bloedon, Kristen Migliaccio-Walle, David Elsea, Steven E. Nissen
Background
In the CLEAR Outcomes study, 13,970 high cardiovascular risk patients with hypercholesterolemia and statin intolerance were randomized to treatment with bempedoic acid or standard of care (placebo). Bempedoic acid reduced the risk of major adverse cardiovascular events by 13%. However, the cost-effectiveness of bempedoic acid in this patient population is unknown.
Methods
Markov modeling estimated cost-effectiveness of bempedoic acid versus standard of care alone to reduce cardiovascular risk from a US third-party payer perspective. Baseline risk was estimated by applying individual patient characteristics from the trial to established risk equations. Treatment benefit was extrapolated over a lifetime horizon using hazard ratios for individual major adverse cardiovascular event (MACE) components from CLEAR Outcomes. Scenario analyses included on-treatment analysis, alternate bempedoic acid costs, and modeling effects of the fixed-dose combination with ezetimibe on low-density lipoprotein cholesterol (LDL-C) reduction and predicted MACE.
Results
Bempedoic acid was estimated to reduce lifetime MACE (1.58 versus 1.95 per patient) versus standard of care. At list price, bempedoic acid was associated with increased costs (+ $22,600) and improved quality-adjusted life-years (QALYs, + 0.14), resulting in an incremental cost-effectiveness ratio (ICER) of $166,830 per QALY. The on-treatment analysis resulted in an ICER of $70,279 per QALY. Reduction in bempedoic acid price by 25% resulted in lower incremental total costs and an ICER of $99,993 per QALY. Modeling the effects of the fixed-dose combination resulted in an ICER of $40,317 per QALY.
Conclusions
Use of bempedoic acid offers improved lifetime cardiovascular (CV) risk reduction over standard of care in patients with or at high risk for CV disease (CVD) at common cost-effectiveness thresholds ($150,000 per QALY).
{"title":"Cost-Effectiveness of Bempedoic Acid in High Cardiovascular Risk Patients with Statin Intolerance: An Analysis of the CLEAR Outcomes Trial","authors":"Stephen J. Nicholls, Kausik K. Ray, A. Michael Lincoff, Evelyn Sarnes, Kristin K. Gillard, LeAnne Bloedon, Kristen Migliaccio-Walle, David Elsea, Steven E. Nissen","doi":"10.1007/s40256-025-00753-w","DOIUrl":"10.1007/s40256-025-00753-w","url":null,"abstract":"<div><h3>Background</h3><p>In the CLEAR Outcomes study, 13,970 high cardiovascular risk patients with hypercholesterolemia and statin intolerance were randomized to treatment with bempedoic acid or standard of care (placebo). Bempedoic acid reduced the risk of major adverse cardiovascular events by 13%. However, the cost-effectiveness of bempedoic acid in this patient population is unknown.</p><h3>Methods</h3><p>Markov modeling estimated cost-effectiveness of bempedoic acid versus standard of care alone to reduce cardiovascular risk from a US third-party payer perspective. Baseline risk was estimated by applying individual patient characteristics from the trial to established risk equations. Treatment benefit was extrapolated over a lifetime horizon using hazard ratios for individual major adverse cardiovascular event (MACE) components from CLEAR Outcomes. Scenario analyses included on-treatment analysis, alternate bempedoic acid costs, and modeling effects of the fixed-dose combination with ezetimibe on low-density lipoprotein cholesterol (LDL-C) reduction and predicted MACE.</p><h3>Results</h3><p>Bempedoic acid was estimated to reduce lifetime MACE (1.58 versus 1.95 per patient) versus standard of care. At list price, bempedoic acid was associated with increased costs (+ $22,600) and improved quality-adjusted life-years (QALYs, + 0.14), resulting in an incremental cost-effectiveness ratio (ICER) of $166,830 per QALY. The on-treatment analysis resulted in an ICER of $70,279 per QALY. Reduction in bempedoic acid price by 25% resulted in lower incremental total costs and an ICER of $99,993 per QALY. Modeling the effects of the fixed-dose combination resulted in an ICER of $40,317 per QALY.</p><h3>Conclusions</h3><p>Use of bempedoic acid offers improved lifetime cardiovascular (CV) risk reduction over standard of care in patients with or at high risk for CV disease (CVD) at common cost-effectiveness thresholds ($150,000 per QALY).</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier: NCT02993406 (CLEAR Outcomes study).</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"26 1","pages":"59 - 70"},"PeriodicalIF":3.0,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-025-00753-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-07DOI: 10.1007/s40256-025-00756-7
Panagiotis I. Georgianos, Ioannis Kontogiorgos, Vasilios Vaios, Konstantinos Leivaditis, Vassilios Liakopoulos
{"title":"Should We Use Renin–Angiotensin-System Inhibitors As a First-Line Therapy for the Management of Hypertension in Patients Receiving Hemodialysis?","authors":"Panagiotis I. Georgianos, Ioannis Kontogiorgos, Vasilios Vaios, Konstantinos Leivaditis, Vassilios Liakopoulos","doi":"10.1007/s40256-025-00756-7","DOIUrl":"10.1007/s40256-025-00756-7","url":null,"abstract":"","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"26 1","pages":"1 - 5"},"PeriodicalIF":3.0,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-01DOI: 10.1007/s40256-025-00752-x
Noel Dasgupta, Steen Hvitfeldt Poulsen, Michele Emdin, Amrut V. Ambardekar, Keyur B. Shah, Liana Hennum, Rohit Marwah, Melissa Allison, Pruthviraj Shivanna, Suresh Siddhanti, Jean-François Tamby, Heather Falvey, Justin L. Grodin
<div><h3>Introduction</h3><p>Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of heart failure (HF), with a higher prevalence in older patients with comorbidities requiring concomitant medical therapy. Acoramidis is a next-generation transthyretin stabilizer with near-complete protein stabilization (≥ 90%) administered orally twice daily (BID) for treatment of ATTR-CM. We report on oral medication use in patients with ATTR-CM using two complementary sources: the ATTRibute-CM trial and real-world claims data.</p><h3>Methods</h3><p>In the ATTRibute-CM study, participants with ATTR-CM were randomly assigned 2:1 to receive 800 mg of acoramidis hydrochloride or matching placebo BID for 30 months. Participants from acoramidis and placebo groups were pooled for this analysis. Baseline oral medication use was collected upon enrollment in the study. Real-world data were obtained from patients with ATTR-CM in Optum’s deidentified Clinformatics Data Mart Database (Optum CDM) who met the stability criteria. Patients meeting the stability criteria had: (1) ≥ 2 years of continuous enrollment with ≥ 3-months look-back and a 12-month look-forward from index diagnosis, during the study period of 2018–2021 and (2) ≥ 28 days of continuous treatment for a given dosing frequency within the 12-month look-forward period.</p><h3>Results</h3><p>The ATTRibute-CM study randomly assigned 632 participants with ATTR-CM (mean [± SD] age: 77.3 [6.6] years). At entry to the study, 407 (64.4%) participants were using a medication that was administered BID, three times daily (TID), or four times daily (QID), and 392 (62.0%) participants were using at least one medication administered BID. The most frequent BID medications were apixaban, furosemide, metformin, metoprolol, and carvedilol. In ATTRibute-CM, accountability to acoramidis was high (97.1%).</p><p>From a pool of 2.46 million patients with HF and cardiomyopathy identified in the Optum CDM, 12,116 patients (mean [± SD] age: 76.3 [9.4] years) met the criteria for ATTR-CM, and 5601 patients met the stability criteria. Analysis from this real-world database demonstrated that 4351 (92.1%) patients were prescribed a medication that was administered BID, TID, or QID and 4166 (88.2%) patients were prescribed at least one BID medication. The most frequent medications regardless of dosing frequency included furosemide, atorvastatin, metoprolol, apixaban, and carvedilol. The most frequent BID medications were apixaban, carvedilol, furosemide, metoprolol, and potassium chloride.</p><h3>Conclusions</h3><p>Patients with ATTR-CM take oral medications administered multiple times a day for the treatment of HF and other comorbidities. As a BID medication, acoramidis does not appear to deviate from non-ATTR-CM pharmacotherapy strategies, and is therefore not expected to impose additional burden in a real-world setting. These data suggest that acoramidis may align with and could possibly be incorporated into p
{"title":"Contemporary Oral Medication Use and Frequency in Patients with Transthyretin Amyloid Cardiomyopathy","authors":"Noel Dasgupta, Steen Hvitfeldt Poulsen, Michele Emdin, Amrut V. Ambardekar, Keyur B. Shah, Liana Hennum, Rohit Marwah, Melissa Allison, Pruthviraj Shivanna, Suresh Siddhanti, Jean-François Tamby, Heather Falvey, Justin L. Grodin","doi":"10.1007/s40256-025-00752-x","DOIUrl":"10.1007/s40256-025-00752-x","url":null,"abstract":"<div><h3>Introduction</h3><p>Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of heart failure (HF), with a higher prevalence in older patients with comorbidities requiring concomitant medical therapy. Acoramidis is a next-generation transthyretin stabilizer with near-complete protein stabilization (≥ 90%) administered orally twice daily (BID) for treatment of ATTR-CM. We report on oral medication use in patients with ATTR-CM using two complementary sources: the ATTRibute-CM trial and real-world claims data.</p><h3>Methods</h3><p>In the ATTRibute-CM study, participants with ATTR-CM were randomly assigned 2:1 to receive 800 mg of acoramidis hydrochloride or matching placebo BID for 30 months. Participants from acoramidis and placebo groups were pooled for this analysis. Baseline oral medication use was collected upon enrollment in the study. Real-world data were obtained from patients with ATTR-CM in Optum’s deidentified Clinformatics Data Mart Database (Optum CDM) who met the stability criteria. Patients meeting the stability criteria had: (1) ≥ 2 years of continuous enrollment with ≥ 3-months look-back and a 12-month look-forward from index diagnosis, during the study period of 2018–2021 and (2) ≥ 28 days of continuous treatment for a given dosing frequency within the 12-month look-forward period.</p><h3>Results</h3><p>The ATTRibute-CM study randomly assigned 632 participants with ATTR-CM (mean [± SD] age: 77.3 [6.6] years). At entry to the study, 407 (64.4%) participants were using a medication that was administered BID, three times daily (TID), or four times daily (QID), and 392 (62.0%) participants were using at least one medication administered BID. The most frequent BID medications were apixaban, furosemide, metformin, metoprolol, and carvedilol. In ATTRibute-CM, accountability to acoramidis was high (97.1%).</p><p>From a pool of 2.46 million patients with HF and cardiomyopathy identified in the Optum CDM, 12,116 patients (mean [± SD] age: 76.3 [9.4] years) met the criteria for ATTR-CM, and 5601 patients met the stability criteria. Analysis from this real-world database demonstrated that 4351 (92.1%) patients were prescribed a medication that was administered BID, TID, or QID and 4166 (88.2%) patients were prescribed at least one BID medication. The most frequent medications regardless of dosing frequency included furosemide, atorvastatin, metoprolol, apixaban, and carvedilol. The most frequent BID medications were apixaban, carvedilol, furosemide, metoprolol, and potassium chloride.</p><h3>Conclusions</h3><p>Patients with ATTR-CM take oral medications administered multiple times a day for the treatment of HF and other comorbidities. As a BID medication, acoramidis does not appear to deviate from non-ATTR-CM pharmacotherapy strategies, and is therefore not expected to impose additional burden in a real-world setting. These data suggest that acoramidis may align with and could possibly be incorporated into p","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 6","pages":"829 - 839"},"PeriodicalIF":3.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-025-00752-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-30DOI: 10.1007/s40256-025-00746-9
Julia M. Umińska, Tomasz Fabiszak
{"title":"Comment on: “Morphine and P2Y12 Inhibitors in ST-Elevation Myocardial Infarction: An Updated Meta-Analysis”","authors":"Julia M. Umińska, Tomasz Fabiszak","doi":"10.1007/s40256-025-00746-9","DOIUrl":"10.1007/s40256-025-00746-9","url":null,"abstract":"","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 5","pages":"727 - 728"},"PeriodicalIF":3.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-27DOI: 10.1007/s40256-025-00744-x
Ana Paula Oliveira Vilela, Flávia Deffert, Fernanda S. Tonin, Roberto Pontarolo
Background
Higher quality scaled-up evidence on pulmonary arterial hypertension (PAH), a rare and life-threatening disease, is needed to support informed decision-making. We aimed to map the current knowledge of PAH treatments and evaluate the methodological quality of published systematic reviews.
Methods
An overview with literature searches in PubMed and Embase (May 2025) was performed (CRD42023414469). The methodological and reporting quality of the eligible records was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist, respectively. Association analyses between tools’ scores with key variables (article publication date, journal impact factor, country/region) were performed (SPSS v.28). An evidence map summarizing the most reported treatments and outcomes was also built.
Results
Overall, 57 systematic reviews (n = 52; 91.2% with meta-analysis) published between 1997 and 2025 (median year 2017), authored mostly by countries from Asia (n = 35; 61.4%) and North America (n = 12; 21.1%), were included. The classes of phosphodiesterase type-5 inhibitors, endothelin receptor antagonists, and prostanoids and combination therapies were each assessed in one-third of the studies each. Over 20 different outcomes were reported, with the most common surrogate endpoints being 6-min walking distance (n = 42; 73.7%) and mean pulmonary arterial pressure (n = 33; 57.9%). Most studies were classified as having critically low methodological quality (n = 48; 84.2%), with only three presenting high-quality methodology according to AMSTAR 2. The mean PRISMA score was 21.3 ± 2.9, indicating an adherence rate of 78.9% to the checklist among authors. Although there was an improvement over time in the quality of the reviews (p = 0.016 for AMSTAR; p = 0.002 for PRISMA), no correlations were found based on country nor journal impact factor.
Conclusions
Methodological weaknesses remain common in systematic reviews of PAH; therefore, enforcing compliance with guidelines and standardizing outcome measurements through a core outcome set is crucial for improving data comparability and clinical application.
{"title":"Overview of Systematic Reviews on Treatments for Pulmonary Arterial Hypertension: Assessing Methodological Quality and Mapping Evidence Gaps","authors":"Ana Paula Oliveira Vilela, Flávia Deffert, Fernanda S. Tonin, Roberto Pontarolo","doi":"10.1007/s40256-025-00744-x","DOIUrl":"10.1007/s40256-025-00744-x","url":null,"abstract":"<div><h3>Background</h3><p>Higher quality scaled-up evidence on pulmonary arterial hypertension (PAH), a rare and life-threatening disease, is needed to support informed decision-making. We aimed to map the current knowledge of PAH treatments and evaluate the methodological quality of published systematic reviews.</p><h3>Methods</h3><p>An overview with literature searches in PubMed and Embase (May 2025) was performed (CRD42023414469). The methodological and reporting quality of the eligible records was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist, respectively. Association analyses between tools’ scores with key variables (article publication date, journal impact factor, country/region) were performed (SPSS v.28). An evidence map summarizing the most reported treatments and outcomes was also built.</p><h3>Results</h3><p>Overall, 57 systematic reviews (<i>n</i> = 52; 91.2% with meta-analysis) published between 1997 and 2025 (median year 2017), authored mostly by countries from Asia (<i>n</i> = 35; 61.4%) and North America (<i>n</i> = 12; 21.1%), were included. The classes of phosphodiesterase type-5 inhibitors, endothelin receptor antagonists, and prostanoids and combination therapies were each assessed in one-third of the studies each. Over 20 different outcomes were reported, with the most common surrogate endpoints being 6-min walking distance (<i>n</i> = 42; 73.7%) and mean pulmonary arterial pressure (<i>n</i> = 33; 57.9%). Most studies were classified as having critically low methodological quality (<i>n</i> = 48; 84.2%), with only three presenting high-quality methodology according to AMSTAR 2. The mean PRISMA score was 21.3 ± 2.9, indicating an adherence rate of 78.9% to the checklist among authors. Although there was an improvement over time in the quality of the reviews (<i>p</i> = 0.016 for AMSTAR; <i>p</i> = 0.002 for PRISMA), no correlations were found based on country nor journal impact factor.</p><h3>Conclusions</h3><p>Methodological weaknesses remain common in systematic reviews of PAH; therefore, enforcing compliance with guidelines and standardizing outcome measurements through a core outcome set is crucial for improving data comparability and clinical application.</p><h3>Registration</h3><p>PROSPERO identifier no. CRD42023414469.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 6","pages":"779 - 802"},"PeriodicalIF":3.0,"publicationDate":"2025-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-25DOI: 10.1007/s40256-025-00755-8
Jiann-Der Lee, Chuan-Pin Lee, Yen-Chu Huang, Meng Lee, Ya-Wen Kuo
Background
Cholinesterase inhibitors (ChEIs) are widely prescribed for dementia, but their effects on cardiovascular outcomes in high-risk populations remain unclear.
Objectives
Our objective was to evaluate the association between ChEI use and the risk of major adverse cardiovascular events (MACE) and all-cause mortality among individuals with high cardiovascular risk.
Methods
We conducted a retrospective cohort study using data from the Chang Gung Research Database in Taiwan from 2001 to 2022. Individuals aged ≥ 50 years with cardiovascular risk factors who received ChEIs were matched 1:1 with non-users based on birth year, sex, history of dementia, and cardiovascular comorbidities. The primary outcome was time to first MACE, defined as hospitalization for acute ischemic stroke, acute myocardial infarction, or cardiovascular death. Secondary outcomes included individual cardiovascular events, heart failure, and all-cause mortality. Competing risk and survival analyses were performed using Fine and Gray subdistribution hazard models and Cox proportional hazards models, respectively.
Results
Among 21,598 matched patients (mean age 77.7 years; 61.1% female), ChEI use was associated with a significantly reduced risk of MACE (adjusted subdistribution hazard ratio 0.79; 95% confidence interval 0.74–0.84; P < 0.001) and acute myocardial infarction (adjusted subdistribution hazard ratio 0.70; 95% confidence interval 0.55–0.90; P = 0.006). ChEI users also had significantly improved overall survival (log-rank P < 0.001).
Conclusions
ChEI use is associated with a lower risk of major cardiovascular events and improved survival in patients at high cardiovascular risk. These findings suggest potential cardiovascular benefits of ChEIs beyond cognitive symptom management.
背景：胆碱酯酶抑制剂（ChEIs）被广泛用于治疗痴呆，但其对高危人群心血管结局的影响尚不清楚。目的：我们的目的是评估ChEI使用与心血管高危人群主要不良事件（MACE）风险和全因死亡率之间的关系。方法：我们使用2001年至2022年台湾长庚研究数据库的数据进行回顾性队列研究。年龄≥50岁且有心血管危险因素的接受ChEIs的个体与未使用ChEIs的个体根据出生年份、性别、痴呆史和心血管合并症进行1:1匹配。主要终点是首次发生MACE的时间，定义为急性缺血性卒中、急性心肌梗死或心血管死亡的住院时间。次要结局包括个体心血管事件、心力衰竭和全因死亡率。竞争风险和生存分析分别使用Fine和Gray亚分布风险模型和Cox比例风险模型进行。结果：21598例匹配患者(平均年龄77.7岁；61.1%女性)，使用ChEI与MACE风险显著降低相关(调整后亚分布风险比0.79；95%置信区间0.74-0.84；P < 0.001)和急性心肌梗死(调整后亚分布风险比0.70；95%置信区间0.55-0.90；P = 0.006)。ChEI使用者的总生存率也显著提高（log-rank P < 0.001）。结论：在心血管高危患者中，使用ChEI可降低主要心血管事件的风险，提高生存率。这些发现表明，ChEIs的潜在心血管益处超出了认知症状管理。
{"title":"Cardiovascular Outcomes Associated with Cholinesterase Inhibitor Use in Individuals at High Cardiovascular Risk","authors":"Jiann-Der Lee, Chuan-Pin Lee, Yen-Chu Huang, Meng Lee, Ya-Wen Kuo","doi":"10.1007/s40256-025-00755-8","DOIUrl":"10.1007/s40256-025-00755-8","url":null,"abstract":"<div><h3>Background</h3><p>Cholinesterase inhibitors (ChEIs) are widely prescribed for dementia, but their effects on cardiovascular outcomes in high-risk populations remain unclear.</p><h3>Objectives</h3><p>Our objective was to evaluate the association between ChEI use and the risk of major adverse cardiovascular events (MACE) and all-cause mortality among individuals with high cardiovascular risk.</p><h3>Methods</h3><p>We conducted a retrospective cohort study using data from the Chang Gung Research Database in Taiwan from 2001 to 2022. Individuals aged ≥ 50 years with cardiovascular risk factors who received ChEIs were matched 1:1 with non-users based on birth year, sex, history of dementia, and cardiovascular comorbidities. The primary outcome was time to first MACE, defined as hospitalization for acute ischemic stroke, acute myocardial infarction, or cardiovascular death. Secondary outcomes included individual cardiovascular events, heart failure, and all-cause mortality. Competing risk and survival analyses were performed using Fine and Gray subdistribution hazard models and Cox proportional hazards models, respectively.</p><h3>Results</h3><p>Among 21,598 matched patients (mean age 77.7 years; 61.1% female), ChEI use was associated with a significantly reduced risk of MACE (adjusted subdistribution hazard ratio 0.79; 95% confidence interval 0.74–0.84; <i>P</i> < 0.001) and acute myocardial infarction (adjusted subdistribution hazard ratio 0.70; 95% confidence interval 0.55–0.90; <i>P</i> = 0.006). ChEI users also had significantly improved overall survival (log-rank <i>P</i> < 0.001).</p><h3>Conclusions</h3><p>ChEI use is associated with a lower risk of major cardiovascular events and improved survival in patients at high cardiovascular risk. These findings suggest potential cardiovascular benefits of ChEIs beyond cognitive symptom management.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 6","pages":"817 - 828"},"PeriodicalIF":3.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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