Burkhard Weisser, Sven Wassmann, Hans-Georg Predel, Roland E Schmieder, Anton Gillessen, Thomas Wilke, Jörg Blettenberg, Olaf Randerath, Antje Mevius, Michael Böhm
{"title":"Effect of a single pill concept on clinical and pharmacoeconomic outcomes in cardiovascular diseases.","authors":"Burkhard Weisser, Sven Wassmann, Hans-Georg Predel, Roland E Schmieder, Anton Gillessen, Thomas Wilke, Jörg Blettenberg, Olaf Randerath, Antje Mevius, Michael Böhm","doi":"10.1093/ehjcvp/pvae059","DOIUrl":"10.1093/ehjcvp/pvae059","url":null,"abstract":"<p><strong>Aims: </strong>Our study aimed to assess whether a single pill concept (SPC) is superior to a multi-pill concept (MPC) in reducing cardiovascular (CV) events, all-cause death, and costs in CV patients.</p><p><strong>Method and results: </strong>Anonymized medical claims data covering 2012-2018, including patients with hypertension, dyslipidaemia, and CV diseases who started a drug therapy either as SPC or identical MPC were analysed after 1:1-propensity score matching. Hospitalizations with predefined CV events, all-cause mortality, and costs were studied in 25 311 patients with SPC and 25 311 patients with MPC using incidence rate ratios (IRRs) and non-parametric tests for continuous variables.IRRs were significantly lower for SPC: stroke (IRR = 0.77; 95% CI 0.67-0.88; P < 0.001), transitory ischaemic attack (IRR = 0.61; 95% CI 0.48-0.78; P < 0.001), myocardial infarction (IRR = 0.76; 95% CI 0.63-0.90; P = 0.0016), coronary artery disease (IRR = 0.66; 95% CI 0.57-0.77; P < 0.001), heart failure (IRR = 0.59; 95% CI 0.54-0.64; P < 0.001), acute renal failure (IRR = 0.54; 95% CI 0.56-0.64; P < 0.001), all cause hospitalization (IRR = 0.72; 95% CI 0.71-0.74; P < 0.001), CV hospitalization (IRR = 0.63; 95% CI 0.57-0.69; P < 0.001), and all-cause mortality (IRR = 0.62; 95% CI 0.57-0.68; P < 0.001). Mean time to first events and time to death were also in favour of SPC. Mean total costs were 4708€ for SPC vs. 5.669€ for MPC, respectively (mean ratio 0.830, P < 0.001).</p><p><strong>Conclusion: </strong>SPC is associated with lower incidence rates of CV events, time to CV events, and all-cause death, and is superior regarding pharmacoeconomic parameters and should therefore become standard of care to improve outcomes and reduce healthcare costs.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"686-693"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724138/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859429","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}
Marco Zuin, Alberto Corsini, Chiara Dalla Valle, Catia De Rosa, Alessandro Maloberti, Marco Mojoli, Massimiliano Rizzo, Francesco Ciccirillo, Alfredo Madrid, Carmine Riccio, Massimo Grimaldi, Furio Colivicchi, Fabrizio Oliva, Pier Luigi Temporelli
{"title":"Role of PCSK9 inhibitors in venous thromboembolism: current evidence and unmet clinical needs.","authors":"Marco Zuin, Alberto Corsini, Chiara Dalla Valle, Catia De Rosa, Alessandro Maloberti, Marco Mojoli, Massimiliano Rizzo, Francesco Ciccirillo, Alfredo Madrid, Carmine Riccio, Massimo Grimaldi, Furio Colivicchi, Fabrizio Oliva, Pier Luigi Temporelli","doi":"10.1093/ehjcvp/pvae076","DOIUrl":"10.1093/ehjcvp/pvae076","url":null,"abstract":"<p><p>Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have recently emerged as promising therapeutic agents for lowering low-density lipoprotein cholesterol and reducing the risk of cardiovascular events. Moreover, preliminary evidence from randomized controlled trials (RCTs) suggests that PCSK9i may also offer beneficial effects for patients following venous thromboembolism (VTE), with the most significant reductions in risk appearing over time, particularly beyond the first year of treatment. However, there is a lack of randomized controlled data supporting their efficacy and safety in conjunction with standard anticoagulation therapy. This article aims to critically evaluate the existing evidence for the use of PCSK9i as a complementary therapy for VTE risk reduction, while also identifying unmet clinical and research needs and proposing potential strategies to address these knowledge gaps.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"719-724"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461064","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}
{"title":"Reaping the rewards of a simplified dosing regimen.","authors":"Peter E Penson, Maciej Banach","doi":"10.1093/ehjcvp/pvae073","DOIUrl":"10.1093/ehjcvp/pvae073","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"694-696"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582478","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}
Seung-Jun Lee, Jae Hong Joo, Sohee Park, Choongki Kim, Dong-Woo Choi, Yong-Joon Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Chung-Mo Nam, Myeong-Ki Hong
{"title":"Combination therapy with moderate-intensity atorvastatin and ezetimibe vs. high-intensity atorvastatin monotherapy in patients treated with percutaneous coronary intervention in practice: assessing RACING generalizability.","authors":"Seung-Jun Lee, Jae Hong Joo, Sohee Park, Choongki Kim, Dong-Woo Choi, Yong-Joon Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Chung-Mo Nam, Myeong-Ki Hong","doi":"10.1093/ehjcvp/pvad083","DOIUrl":"10.1093/ehjcvp/pvad083","url":null,"abstract":"<p><strong>Aims: </strong>Using rosuvastatin, the RACING (randomized comparison of efficacy and safety of lipid-lowering with statin monotherapy versus statin/ezetimibe combination for high-risk cardiovascular diseases) trial showed the beneficial effects of combining moderate-intensity statin with ezetimibe compared with high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease. This study investigated whether the beneficial effects of combination lipid-lowering therapy extend to patients treated with atorvastatin, not rosuvastatin, in daily clinical practice.</p><p><strong>Methods and results: </strong>Using stabilized inverse probability of treatment weighting, a total of 31 993 patients who were prescribed atorvastatin after drug-eluting stent (DES) implantation were identified from a nationwide cohort database: 6215 patients with atorvastatin 20 mg plus ezetimibe 10 mg (combination lipid-lowering therapy) and 25 778 patients with atorvastatin 40-80 mg monotherapy. The primary endpoint was the 3-year composite of cardiovascular death, myocardial infarction, coronary artery revascularization, hospitalization for heart failure treatment, or non-fatal stroke in accordance with the RACING trial design. Combination lipid-lowering therapy was associated with a lower incidence of the primary endpoint (12.9% vs. 15.1% in high-intensity atorvastatin monotherapy; hazard ratio [HR] 0.81, 95% confidence interval [CI] 0.74-0.88, P < 0.001). Compared with high-intensity atorvastatin monotherapy, combination lipid-lowering therapy was also significantly associated with lower rates of statin discontinuation (10.0% vs. 8.4%, HR 0.81, 95% CI 0.73-0.90, P < 0.001) and new-onset diabetes requiring medication (8.8% vs. 7.0%, HR 0.80, 95% CI 0.70-0.92, P = 0.002).</p><p><strong>Conclusion: </strong>In clinical practice, a combined lipid-lowering approach utilizing ezetimibe and moderate-intensity atorvastatin was correlated with favourable clinical outcomes, drug compliance, and a reduced incidence of new-onset diabetes requiring medications in patients treated with DES implantation. Trial registration: ClinicalTrial.gov (NCT04715594).</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"676-685"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89717487","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}
Katarina Mars, Sophia Humphries, Philip Leissner, Martin Jonsson, Patric Karlström, Jörg Lauermann, Joakim Alfredsson, Thomas Kellerth, Annica Ravn-Fischer, David Erlinge, Bertil Lindahl, Troels Yndigegn, Tomas Jernberg, Claes Held, Erik M G Olsson, Robin Hofmann
{"title":"Effects of beta-blockers on quality of life and well-being in patients with myocardial infarction and preserved left ventricular function-a prespecified substudy from REDUCE-AMI.","authors":"Katarina Mars, Sophia Humphries, Philip Leissner, Martin Jonsson, Patric Karlström, Jörg Lauermann, Joakim Alfredsson, Thomas Kellerth, Annica Ravn-Fischer, David Erlinge, Bertil Lindahl, Troels Yndigegn, Tomas Jernberg, Claes Held, Erik M G Olsson, Robin Hofmann","doi":"10.1093/ehjcvp/pvae062","DOIUrl":"10.1093/ehjcvp/pvae062","url":null,"abstract":"<p><strong>Aims: </strong>In the Randomized Evaluation of Decreased Usage of Beta-Blockers after Acute Myocardial Infarction (REDUCE-AMI) study, long-term beta-blocker use in patients after acute myocardial infarction (AMI) with preserved left ventricular ejection fraction demonstrated no effect on death or cardiovascular outcomes. The aim of this prespecified substudy was to investigate effects of beta-blockers on self-reported quality of life and well-being.</p><p><strong>Methods and results: </strong>From this parallel-group, open-label, registry-based randomized clinical trial, EQ-5D, and World Health Organization well-being index-5 (WHO-5) questionnaires were obtained at 6-10 weeks and 11-13 months after AMI in 4080 and 806 patients, respectively. We report results from intention-to-treat and on-treatment analyses for the overall population and relevant subgroups using Wilcoxon rank sum test and adjusted ordinal regression analyses. Of the 4080 individuals reporting EQ-5D (median age 64 years, 22% female), 2023 were randomized to beta-blockers. The main outcome, median EQ-5D index score, was 0.94 [interquartile range (IQR) 0.88, 0.97] in the beta-blocker group, and 0.94 (IQR 0.88, 0.97) in the no-beta-blocker group 6-10 weeks after AMI, OR 1.00 [95% CI 0.89-1.13; P > 0.9]. After 11-13 months, results remained unchanged. Findings were robust in on-treatment analyses and across relevant subgroups. Secondary outcomes, EQ-VAS and WHO-5 index score, confirmed these results.</p><p><strong>Conclusion: </strong>Among patients after AMI with preserved left ventricular ejection fraction, self-reported quality of life and well-being was not significantly different in individuals randomized to routine long-term beta-blocker therapy as compared to individuals with no beta-blocker use. These results appear consistent regardless of adherence to randomized treatment and across subgroups which emphasizes the need for a careful individual risk-benefit evaluation prior to initiation of beta-blocker treatment.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"708-718"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105745","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}
{"title":"Editorial on incidence and outcomes of transient new onset atrial fibrillation complicating acute coronary syndromes: results from a systematic review and meta-analysis.","authors":"Ashwin Balu, Ingeborg Welters, Gregory Y H Lip","doi":"10.1093/ehjcvp/pvae067","DOIUrl":"10.1093/ehjcvp/pvae067","url":null,"abstract":"","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"662-664"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544440","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}
Marc P Bonaca, Andrei-Mircea Catarig, Yasemin Hansen, Kim Houlind, Chethana Kalmady Ramesh, Bernhard Ludvik, Joakim Nordanstig, Neda Rasouli, Harald Sourij, Subodh Verma
{"title":"Design and baseline characteristics of the STRIDE trial: evaluating semaglutide in people with symptomatic peripheral artery disease and type 2 diabetes.","authors":"Marc P Bonaca, Andrei-Mircea Catarig, Yasemin Hansen, Kim Houlind, Chethana Kalmady Ramesh, Bernhard Ludvik, Joakim Nordanstig, Neda Rasouli, Harald Sourij, Subodh Verma","doi":"10.1093/ehjcvp/pvae071","DOIUrl":"10.1093/ehjcvp/pvae071","url":null,"abstract":"<p><strong>Background: </strong>People with lower extremity peripheral artery disease (PAD) suffer from a high burden of symptoms and significant functional impairment. There are few therapies that improve function and reduce symptoms in this population. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been shown to improve glycaemic control, reduce body weight, and reduce the risk of major adverse cardiovascular events in people with atherosclerotic cardiovascular disease and type 2 diabetes (T2D).</p><p><strong>Methods and results: </strong>STRIDE (NCT04560998) is a randomized, placebo-controlled, double-blind phase 3b trial evaluating 1 mg once-weekly subcutaneous semaglutide (GLP-1 RA) vs. placebo, in people with symptomatic PAD (Fontaine IIa claudication) and T2D. Eligible participants were ≥18 years, had haemodynamically stable PAD, had no planned intervention, and were not receiving a GLP-1 RA. The primary endpoint is change in maximum walking distance on a constant-load treadmill (CLT). Secondary endpoints include quality of life and cardiometabolic assessments. A total of 792 participants were randomized in 20 countries. Participants' median age was 68 and median T2D duration 12 years. Risk factors included 25.6% current smokers, 87.9% with hypertension, and 42.7% with coronary heart disease. The mean BMI was 29.6 kg/m2 and the mean HbA1C was 7.3%. Participants exhibited baseline functional impairment with a median maximum walking distance of 186 m on a CLT.</p><p><strong>Conclusion: </strong>STRIDE has enrolled participants with symptomatic PAD and T2D, frequent risk factors and comorbidities, and functional impairment. The trial will provide evidence for the functional outcomes with semaglutide in people with PAD and T2D.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":"728-737"},"PeriodicalIF":5.3,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461060","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}
Claudio Laudani, Giovanni Occhipinti, Antonio Greco, Daniele Giacoppo, Marco Spagnolo, Davide Capodanno
{"title":"A Pairwise and Network Meta-analysis of Anti-inflammatory Strategies After Myocardial Infarction: the TITIAN study.","authors":"Claudio Laudani, Giovanni Occhipinti, Antonio Greco, Daniele Giacoppo, Marco Spagnolo, Davide Capodanno","doi":"10.1093/ehjcvp/pvae100","DOIUrl":"https://doi.org/10.1093/ehjcvp/pvae100","url":null,"abstract":"<p><strong>Background and aims: </strong>Multiple anti-inflammatory drugs have been tested for secondary prevention after myocardial infarction (MI), giving mixed results and questioning the efficacy of anti-inflammatory therapy. No head-to-head comparisons between anti-inflammatory drugs have been performed. This study aimed to compare the efficacy and safety of anti-inflammatory drugs for secondary prevention after MI and the relative merits of specific drugs and administration strategies.</p><p><strong>Methods: </strong>Randomized trials of anti-inflammatory therapy for secondary prevention after MI were identified. Primary efficacy and safety endpoints were trial-defined major adverse cardiovascular events (MACE) and serious adverse events. Secondary endpoints included all-cause death, individual MACE components, serious infection, cancer, and gastrointestinal adverse events. Pairwise meta-analyses were conducted with interaction analyses for drug type and timing of administration, in addition to network meta-analyses. Multiple sensitivity and meta-regression analyses were conducted to explore potential heterogeneity sources.</p><p><strong>Results: </strong>Twenty-eight studies, involving 44 406 patients with a mean follow-up of 11 months, were included. Anti-inflammatory therapy reduced the incidence of major adverse cardiovascular events (MACE) (incidence rate ratio [IRR]: 0.92; 95% confidence interval [CI]: 0.86-0.98), without increasing serious adverse events. However, it was associated with a higher incidence of gastrointestinal adverse events (IRR: 1.21; 95% CI: 1.07-1.36). No significant interaction was observed between the effects of anti-inflammatory therapy on MACE and the timing of administration.</p><p><strong>Conclusions: </strong>In secondary prevention for MI, anti-inflammatory therapy significantly reduces MACE without increasing serious adverse events, but it is associated with an increased risk of gastrointestinal adverse events.</p>","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":5.3,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930948","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}