Masato Uchida, Taisuke Jo, Akira Okada, Hiroki Matsui, Hideo Yasunaga
{"title":"Effectiveness and safety of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation at low risk of stroke in japan: a retrospective cohort study.","authors":"Masato Uchida, Taisuke Jo, Akira Okada, Hiroki Matsui, Hideo Yasunaga","doi":"10.1093/ehjcvp/pvad077","DOIUrl":"10.1093/ehjcvp/pvad077","url":null,"abstract":"<p><strong>Aims: </strong>Contemporary guidelines differ in their recommendations regarding initiating non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) at low risk of stroke. This study aimed to examine the effectiveness and safety of NOACs for low-risk AF in a Japanese cohort.</p><p><strong>Methods and results: </strong>In this retrospective cohort study based on the JMDC Claims Database extracted between April 2011 and November 2022, we identified 13 291 patients with AF at low risk of stroke. We performed inverse probability of treatment weighting Cox regression analyses to compare the embolization and bleeding risks between the nontreatment and NOAC groups. Net clinical benefit was defined as the annual incidence of ischaemic stroke events prevented by NOACs after subtracting intracranial haemorrhage (ICH) events attributable to NOACs, multiplied by a weighting factor. The incidences of stroke and ICH in the nontreatment group were 0.47 and 0.15 per 100 person-years, respectively. The NOAC group had higher incidences of ICH (hazard ratio [HR]: 1.73, 95% confidence interval [CI]: 0.75-4.00) and stroke (HR: 1.41, 95% CI: 0.84-2.36). The net clinical benefit of NOAC treatment was -0.35% per year (95% CI: -0.99-0.29%).</p><p><strong>Conclusion: </strong>Non-vitamin K antagonist oral anticoagulants treatment may be associated with a slightly high risk of ICH, and it yielded a neutral clinical benefit in the present Japanese population, which provides reassurance concerning the role of ethnicity in NOAC treatment for patients with AF and suggests a need to assess comprehensive weighting of the respective risk factors.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49675750","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}
{"title":"Anticoagulation in cancer-associated thrombosis: how long should the therapy be?","authors":"Wei Xiong, Stefan Agewall, Yugo Yamashita","doi":"10.1093/ehjcvp/pvad075","DOIUrl":"10.1093/ehjcvp/pvad075","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41195695","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}
Eirik Ikdahl, Silvia Rollefstad, Amirhossein Kazemi, Sella A Provan, Trine-Lise Larsen, Anne Grete Semb
{"title":"Non-steroidal anti-inflammatory drugs and risk of pulmonary embolism in patients with inflammatory joint disease-results from the nationwide Norwegian Cardio-rheuma registry.","authors":"Eirik Ikdahl, Silvia Rollefstad, Amirhossein Kazemi, Sella A Provan, Trine-Lise Larsen, Anne Grete Semb","doi":"10.1093/ehjcvp/pvad078","DOIUrl":"10.1093/ehjcvp/pvad078","url":null,"abstract":"<p><strong>Aims: </strong>Patients with inflammatory joint diseases (IJD), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) have increased rates of pulmonary embolism (PE). Non-steroidal anti-inflammatory drugs (NSAIDs) use is associated with PE in the general population. Our aim was to evaluate the association between NSAIDs use and PE in IJD patients.</p><p><strong>Methods and results: </strong>Using individual-level registry data from the whole Norwegian population, including data from the Norwegian Patient Registry and the Norwegian Prescription Database, we: (1) evaluated PE risk in IJD compared to non-IJD individuals, (2) applied the self-controlled case series method to evaluate if PE risks were associated with use of traditional NSAIDs (tNSAIDs) and selective cox-2 inhibitors (coxibs). After a one-year wash-out period, we followed 4 660 475 adults, including 74 001 with IJD (RA: 39 050, PsA: 20 803, and axSpA: 18 591) for a median of 9.0 years. Crude PE incidence rates per 1000 patient years were 2.02 in IJD and 1.01 in non-IJD individuals. Age and sex adjusted hazard ratios for PE events were 1.57 for IJD patients compared to non-IJD. Incidence rate ratios (IRR) [95% confidence interval (CI)] for PE during tNSAIDs use were 0.78 (0.64-0.94, P = 0.010) in IJD and 1.68 (1.61-1.76, P < 0.001) in non-IJD. IRR (95% CI) for PE during coxibs use was 1.75 (1.10-2.79, P = 0.018) in IJD and 2.80 (2.47-3.18, P < 0.001) for non-IJD.</p><p><strong>Conclusion: </strong>Pulmonary embolism rates appeared to be higher in IJD than among non-IJD subjects in our study. Traditional NSAIDs may protect against PE in IJD patients, while coxibs may associated with increased PE risk.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10766907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50161207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J Ball, J T Neumann, A M Tonkin, P Kirchhof, B Freedman, A Brodtmann, C Reid, M R Nelson, L J Beilin, S Fitzgerald, D Stub, R L Woods, J J McNeil
{"title":"Low-dose aspirin and incident atrial fibrillation in healthy older individuals: a post-hoc analysis of the ASPREE trial.","authors":"J Ball, J T Neumann, A M Tonkin, P Kirchhof, B Freedman, A Brodtmann, C Reid, M R Nelson, L J Beilin, S Fitzgerald, D Stub, R L Woods, J J McNeil","doi":"10.1093/ehjcvp/pvad082","DOIUrl":"10.1093/ehjcvp/pvad082","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10766903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89717488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanna Osmanska, Katriona Brooksbank, Kieran F Docherty, Stacy Robertson, Kirsty Wetherall, Alex McConnachie, Jerry Hu, Roy S Gardner, Andrew L Clark, Iain B Squire, Paul R Kalra, Pardeep S Jhund, Pieter Muntendam, John J V McMurray, Mark C Petrie, Ross T Campbell
{"title":"A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies.","authors":"Joanna Osmanska, Katriona Brooksbank, Kieran F Docherty, Stacy Robertson, Kirsty Wetherall, Alex McConnachie, Jerry Hu, Roy S Gardner, Andrew L Clark, Iain B Squire, Paul R Kalra, Pardeep S Jhund, Pieter Muntendam, John J V McMurray, Mark C Petrie, Ross T Campbell","doi":"10.1093/ehjcvp/pvad073","DOIUrl":"10.1093/ehjcvp/pvad073","url":null,"abstract":"<p><strong>Aims: </strong>Subcutaneous (SC) furosemide has potential advantages over intravenous (IV) furosemide by enabling self-administration or administration by a lay caregiver, such as facilitating early discharge, preventing hospitalizations, and in palliative care. A high-concentration, pH-neutral furosemide formulation has been developed for SC administration via a small patch infusor pump. We aimed to compare the bioavailability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of a new SC furosemide formulation with conventional IV furosemide and describe the first use of a bespoke mini-pump to administer this formulation.</p><p><strong>Methods and results: </strong>A novel pH-neutral formulation of SC furosemide containing 80 mg furosemide in ∼2.7 mL (infused over 5 h) was investigated. The first study was a PK/PD study of SC furosemide compared with 80 mg IV furosemide administered as a bolus in ambulatory patients with heart failure (HF). The primary outcome was absolute bioavailability of SC compared with IV furosemide. The second study investigated the same SC furosemide preparation delivered by a patch infusor in patients hospitalized with HF. Primary outcome measures were treatment-emergent adverse events, infusion site pain, device performance, and PK measurements.The absolute bioavailability of SC furosemide in comparison to IV furosemide was 112%, resulting in equivalent diuresis and natriuresis. When SC furosemide was administered via the patch pump, there were no treatment-emergent adverse events and 95% of participants reported no/minor discomfort at the infusion site.</p><p><strong>Conclusion: </strong>The novel preparation of SC furosemide had similar bioavailability to IV furosemide. Administration via a patch pump was feasible and well tolerated.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10766906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41108453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alessandro Spirito, Davide Cao, Samantha Sartori, Ashutosh Sharma, Kenneth F Smith, Birgit Vogel, Karim Kamaleldin, Anoop N Koshy, Yihan Feng, David Power, Usman Baber, Parasuram Krishnamoorthy, George Dangas, Annapoorna Kini, Samin K Sharma, Roxana Mehran
{"title":"Predictive value of the thrombotic risk criteria proposed in the 2023 ESC guidelines for the management of ACS: insights from a large PCI registry.","authors":"Alessandro Spirito, Davide Cao, Samantha Sartori, Ashutosh Sharma, Kenneth F Smith, Birgit Vogel, Karim Kamaleldin, Anoop N Koshy, Yihan Feng, David Power, Usman Baber, Parasuram Krishnamoorthy, George Dangas, Annapoorna Kini, Samin K Sharma, Roxana Mehran","doi":"10.1093/ehjcvp/pvad069","DOIUrl":"10.1093/ehjcvp/pvad069","url":null,"abstract":"<p><strong>Aim: </strong>To assess the value of the thrombotic risk criteria proposed in the 2023 guidelines of the European Society of Cardiology (ESC) for the management of acute coronary syndrome (ACS) to predict the ischaemic risk after percutaneous coronary intervention (PCI).</p><p><strong>Methods and results: </strong>Consecutive patients with acute or chronic coronary syndrome undergoing PCI at a large tertiary-care center from 2014 to 2019 were included. Patients were stratified into low, moderate, or high thrombotic risk based on the ESC criteria. The primary endpoint was major adverse cardiovascular events (MACEs) at 1 year, a composite of all-cause death, myocardial infarction (MI), and stroke. Secondary endpoints included major bleeding. Among 11 787 patients, 2641 (22.4%) were at low-risk, 5286 (44.8%) at moderate risk, and 3860 (32.7%) at high-risk. There was an incremental risk of MACE at 1 year in patients at moderate (hazard ratios (HR) 2.53, 95% confidence interval (CI) 1.78-3.58) and high-risk (HR 3.39, 95% CI 2.39-4.80) as compared to those at low-risk, due to higher rates of all-cause death and MI. Major bleeding rates were increased in high-risk patients (HR 1.59, 95% CI 1.25-2.02), but similar between the moderate and low-risk group. The Harrell's C-index for MACE was 0.60.</p><p><strong>Conclusion: </strong>The thrombotic risk criteria of the 2023 ESC guidelines for ACS enable to stratify patients undergoing PCI in categories with an incremental 1 year risk of MACE; however, their overall predictive ability for MACE is modest. Future studies should confirm the value of these criteria to identify patients benefiting from an extended treatment with a second antithrombotic agent.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41120348","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}
{"title":"Risk of hyperkalaemia in patients with type 2 diabetes mellitus prescribed with SGLT2 versus DPP-4 inhibitors.","authors":"Mei-Zhen Wu, Tiew-Hwa Katherine Teng, Christopher Tze-Wei Tsang, Yap-Hang Chan, Chi-Ho Lee, Qing-Wen Ren, Jia-Yi Huang, Iok-Fai Cheang, Yi-Kei Tse, Xin-Li Li, Xin Xu, Hung-Fat Tse, Carolyn S P Lam, Kai-Hang Yiu","doi":"10.1093/ehjcvp/pvad081","DOIUrl":"10.1093/ehjcvp/pvad081","url":null,"abstract":"<p><strong>Aims: </strong>To investigate the risk of hyperkalaemia in new users of sodium-glucose cotransporter 2 (SGLT2) inhibitors vs. dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes mellitus (T2DM).</p><p><strong>Methods and results: </strong>Patients with T2DM who commenced treatment with an SGLT2 or a DPP-4 inhibitor between 2015 and 2019 were collected. A multivariable Cox proportional hazards analysis was applied to compare the risk of central laboratory-determined severe hyperkalaemia, hyperkalaemia, hypokalaemia (serum potassium ≥6.0, ≥5.5, and <3.5 mmol/L, respectively), and initiation of a potassium binder in patients newly prescribed an SGLT2 or a DPP-4 inhibitor. A total of 28 599 patients (mean age 60 ± 11 years, 60.9% male) were included after 1:2 propensity score matching, of whom 10 586 were new users of SGLT2 inhibitors and 18 013 of DPP-4 inhibitors. During a 2-year follow-up, severe hyperkalaemia developed in 122 SGLT2 inhibitor users and 325 DPP-4 inhibitor users. Use of SGLT2 inhibitors was associated with a 29% reduction in incident severe hyperkalaemia [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.58-0.88] compared with DPP-4 inhibitors. Risk of hyperkalaemia (HR 0.81, 95% CI 0.71-0.92) and prescription of a potassium binder (HR 0.74, 95% CI 0.67-0.82) were likewise decreased with SGLT2 inhibitors compared with DPP-4 inhibitors. Occurrence of incident hypokalaemia was nonetheless similar between those prescribed an SGLT2 inhibitor and those prescribed a DPP-4 inhibitor (HR 0.90, 95% CI 0.81-1.01).</p><p><strong>Conclusion: </strong>Our study provides real-world evidence that compared with DPP-4 inhibitors, SGLT2 inhibitors were associated with lower risk of hyperkalaemia and did not increase the incidence of hypokalaemia in patients with T2DM.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71520909","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}
Wayne C Zheng, William Chan, Anthony Dart, James A Shaw
{"title":"Novel therapeutic targets and emerging treatments for atherosclerotic cardiovascular disease.","authors":"Wayne C Zheng, William Chan, Anthony Dart, James A Shaw","doi":"10.1093/ehjcvp/pvad074","DOIUrl":"10.1093/ehjcvp/pvad074","url":null,"abstract":"<p><p>Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality worldwide. Even with excellent control of low-density lipoprotein cholesterol (LDL-C) levels, adverse cardiovascular events remain a significant clinical problem worldwide, including among those without any traditional ASCVD risk factors. It is necessary to identify novel sources of residual risk and to develop targeted strategies that address them. Lipoprotein(a) has become increasingly recognized as a new cardiovascular risk determinant. Large-scale clinical trials have also signalled the potential additive cardiovascular benefits of decreasing triglycerides beyond lowering LDL-C levels. Since CANTOS (Anti-inflammatory Therapy with Canakinumab for Atherosclerotic Disease) demonstrated that antibodies against interleukin-1β may decrease recurrent cardiovascular events in secondary prevention, various anti-inflammatory medications used for rheumatic conditions and new monoclonal antibody therapeutics have undergone rigorous evaluation. These data build towards a paradigm shift in secondary ASCVD prevention, underscoring the value of targeting multiple biological pathways in the management of both lipid levels and systemic inflammation. Evolving knowledge of the immune system, and the gut microbiota may result in opportunities for modifying previously unrecognized sources of residual inflammatory risk. This review provides an overview of novel therapeutic targets for ASCVD and emerging treatments with a focus on mechanisms, efficacy, and safety.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":7.1,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41182372","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}