American Journal of Cardiovascular Drugs最新文献

{"title":"Impact of Newly Diagnosed Cancer on Bleeding Events in Patients with Atrial Fibrillation Treated with Direct Oral Anticoagulants","authors":"Francesco Angeli,&nbsp;Luca Bergamaschi,&nbsp;Matteo Armillotta,&nbsp;Angelo Sansonetti,&nbsp;Andrea Stefanizzi,&nbsp;Lisa Canton,&nbsp;Francesca Bodega,&nbsp;Nicole Suma,&nbsp;Sara Amicone,&nbsp;Damiano Fedele,&nbsp;Davide Bertolini,&nbsp;Andrea Impellizzeri,&nbsp;Francesco Pio Tattilo,&nbsp;Daniele Cavallo,&nbsp;Lorenzo Bartoli,&nbsp;Ornella Di Iuorio,&nbsp;Khrystyna Ryabenko,&nbsp;Marcello Casuso Alvarez,&nbsp;Virginia Marinelli,&nbsp;Claudio Asta,&nbsp;Mariachiara Ciarlantini,&nbsp;Giuseppe Pastore,&nbsp;Andrea Rinaldi,&nbsp;Daniela Paola Pomata,&nbsp;Ilaria Caldarera,&nbsp;Carmine Pizzi","doi":"10.1007/s40256-024-00676-y","DOIUrl":"10.1007/s40256-024-00676-y","url":null,"abstract":"<div><h3>Background</h3><p>In patients with atrial fibrillation (AF), the association between cancer and cardioembolic or bleeding risk during oral anticoagulant therapy still remains unclear.</p><h3>Purpose</h3><p>We aimed to assess the impact of cancer present at baseline (CB) or diagnosed during follow-up (CFU) on bleeding events in patients treated with direct oral anticoagulants (DOACs) for non-valvular AF (NVAF) compared with patients without CB or CFU, respectively.</p><h3>Methods</h3><p>All consecutive patients with NVAF treated with DOACs for stroke prevention were enrolled between January 2017 and March 2019. Primary outcomes were bleeding events or cardiovascular death, non-fatal stroke and non-fatal myocardial infarction, and the composite endpoint between patients with and without CB and between patients with and without CB.</p><h3>Results</h3><p>The study population comprised 1170 patients who were followed for a mean time of 21.6 ± 9.5 months. Overall, 81 patients (6.9%) were affected by CB, while 81 (6.9%) were diagnosed with CFU. Patients with CFU were associated with a higher risk of bleeding events and major bleeding compared with patients without CFU. Such an association was not observed between the CB and no CB populations. In multivariate analysis adjusted for anemia, age, creatinine, CB and CFU, CFU but not CB remained an independent predictor of overall and major bleeding (hazard ratio [HR] 2.67, 95% confidence interval [CI] 1.8–3.89, <i>p</i> &lt; 0.001; HR 3.02, 95% CI 1.6–3.81, <i>p</i> = 0.001, respectively).</p><h3>Conclusion</h3><p>During follow-up, newly diagnosed primitive or metastatic cancer in patients with NVAF taking DOACs is a strong predictor of major bleeding regardless of baseline hemorrhagic risk assessment. In contrast, such an association is not observed with malignancy at baseline. Appropriate diagnosis and treatment could therefore reduce the risk of cancer-related bleeding.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"813 - 821"},"PeriodicalIF":2.8,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00676-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139020","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}

{"title":"SGLT2 Inhibitors and How They Work Beyond the Glucosuric Effect. State of the Art","authors":"David Aristizábal-Colorado,&nbsp;Martín Ocampo-Posada,&nbsp;Wilfredo Antonio Rivera-Martínez,&nbsp;David Corredor-Rengifo,&nbsp;Jorge Rico-Fontalvo,&nbsp;Juan Esteban Gómez-Mesa,&nbsp;John Jairo Duque-Ossman,&nbsp;Alin Abreu-Lomba","doi":"10.1007/s40256-024-00673-1","DOIUrl":"10.1007/s40256-024-00673-1","url":null,"abstract":"<div><p>Type 2 diabetes mellitus (T2DM) is associated with a heightened risk of cardiovascular and renal complications. While glycemic control remains essential, newer therapeutic options, such as SGLT2 inhibitors, offer additional benefits beyond glucose reduction. This review delves into the mechanisms underlying the cardio-renal protective effects of SGLT2 inhibitors. By inducing relative hypoglycemia, these agents promote ketogenesis, optimize myocardial energy metabolism, and reduce lipotoxicity. Additionally, SGLT2 inhibitors exert renoprotective actions by enhancing renal perfusion, attenuating inflammation, and improving iron metabolism. These pleiotropic effects, including modulation of blood pressure, reduction of uric acid, and improved endothelial function, collectively contribute to the cardiovascular and renal benefits observed with SGLT2 inhibitor therapy. This review will provide clinicians with essential knowledge, understanding, and a clear recollection of this pharmacological group’s mechanism of action.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"707 - 718"},"PeriodicalIF":2.8,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046121","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}

{"title":"Differences in Healthcare Resource Use and Cost by Pharmacotherapy Among Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Real-World Analysis of Claims Data","authors":"Michael Butzner,&nbsp;Eros Papademetriou,&nbsp;Ravi Potluri,&nbsp;Xing Liu,&nbsp;Sanatan Shreay","doi":"10.1007/s40256-024-00674-0","DOIUrl":"10.1007/s40256-024-00674-0","url":null,"abstract":"<div><h3>Background</h3><p>For symptomatic obstructive hypertrophic cardiomyopathy (oHCM), limited evidence exists on healthcare resource utilization (HRU) and cost for patients with symptomatic oHCM by treatment categories. We evaluated whether HRU and costs vary by initial treatment in symptomatic oHCM.</p><h3>Methods</h3><p>This is a retrospective study of medical and pharmacy claims from 2016 to 2021 to identify (per International Classification of Disease Tenth Revision diagnosis codes) adult patients in the USA with symptomatic oHCM. Patients included in the study cohort were required to be treatment naïve (≥ 12 months’ activity before first treatment) and symptomatic (fatigue, chest pain, syncope, dyspnea, heart failure, or palpitations within 3 months of index date). Patients were grouped by first index treatment [beta blocker (BB), calcium channel blockers (CCB), disopyramide, combination therapy], and HRU and costs [per person per year (PPPY), in USD] by initial treatment were reported.</p><h3>Results</h3><p>Among 7334 patients with symptomatic oHCM, initial treatment included BB (65.8%), CCB (21.1%), disopyramide (1.2%), or BB + CCB (11.9%). Overall, 87.2% were prescribed monotherapy. Outpatient visits were the main driver of all-cause HRU (mean 11.5 PPPY), and varied by initial treatment (BB: 11.0, CCB: 10.5, disopyramide: 7.2, combination therapy: 12.1). All-cause urgent care visits were more frequent than inpatient visits (means: 5.4 and 0.83 PPPY, respectively). All-cause incurred costs were $46,628 PPPY overall and varied by treatment (BB: $47,029, CCB: $42,124, disopyramide: $27,007, combination therapy: $54,024).</p><h3>Conclusions</h3><p>In this large, US-based cohort of patients with symptomatic oHCM, initial therapy was most commonly BB and CCB monotherapy. Costs and HRU were high for most patients, but greater for those treated initially with combination therapy.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"801 - 811"},"PeriodicalIF":2.8,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00674-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016041","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}

{"title":"A Real‑World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Mavacamten","authors":"Zeynep Yukselen,&nbsp;Arvind Kumar Venkataramana Raju,&nbsp;Pramukh Arun Kumar,&nbsp;Aditi Ujjawal,&nbsp;Mahati Dasari,&nbsp;Shreyash Parajuli,&nbsp;Michael Nakhla,&nbsp;Kannu Bansal,&nbsp;Sarju Ganatra,&nbsp;Sourbha S. Dani","doi":"10.1007/s40256-024-00672-2","DOIUrl":"10.1007/s40256-024-00672-2","url":null,"abstract":"<div><h3>Background</h3><p>Mavacamten is a first-in-class cardiac myosin inhibitor approved by the US Food and Drug Administration (FDA) for symptomatic obstructive hypertrophic cardiomyopathy (HCM). This pharmacovigilance study aimed to assess mavacamten-related adverse drug reactions (ADRs) in the real world as reported in the FDA Adverse Event Reporting System (FAERS).</p><h3>Methods</h3><p>We conducted disproportionality analyses with four signal detection algorithms—reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and the multi-item gamma Poisson shrinker to identify mavacamten-related ADRs.</p><h3>Results</h3><p>Out of 4,500,131 reports from the FAERS database, 1004 mavacamten-related ADRs were identified from 1 January 2022 to 30 September 2023. A total of 26 significant disproportionality preferred terms (PTs) conforming to the four signal detection algorithms were noted. Some of the statistically significant cardiac ADRs at PT level include decreased ejection fraction (EF) [ROR 33.60 (95% confidence interval, CI 21.79–51.82), PRR 32.86 (<i>χ</i>² 615.96), information component (IC) 5.03, IC025 4.61, empirical Bayesian geometric mean (EBGM) 32.77, EBGM05 21.25], cardiac failure [ROR 9.39 (95% CI 6.49–13.60), PRR 9.13 (<i>χ</i>² 202.42), IC 3.19, IC025 2.83, EBGM 9.12, EBGM05 6.30], and atrial fibrillation [ROR 16.63 (95% CI 12.72–21.75), PRR 15.66 (<i>χ</i>² 769.93), IC 3.97, IC025 3.71, EBGM 15.64, EBGM05 11.96].</p><h3>Conclusions</h3><p>The results of our study were consistent with the safety data of clinical trials, including reduced ejection fraction, atrial fibrillation, dyspnea, and syncope. We also found potential new and unexpected ADR signals, such as urinary tract infection, gout, and peripheral edema.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"791 - 799"},"PeriodicalIF":2.8,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008132","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}

{"title":"Time Gained to Cardiovascular Disease by Intensive Lipid-Lowering Therapy: Results of Individual Placebo-Controlled Trials and Pooled Effects","authors":"Folkert H. van Bruggen,&nbsp;Esther C. de Haas,&nbsp;Sytse U. Zuidema,&nbsp;Hendrika J. Luijendijk","doi":"10.1007/s40256-024-00668-y","DOIUrl":"10.1007/s40256-024-00668-y","url":null,"abstract":"<div><h3>Introduction</h3><p>Despite the effect on blood lipid levels, the clinical benefits of intensive versus standard pharmacological lipid-lowering therapy remain unclear. Previous reviews have presented relative effects on the risk of clinical outcomes, but not the absolute risk reductions (ARRs) and the time gained to a clinical outcome, also called outcome postponement (OP). The aim of this study was to estimate the effect of intensive versus standard lipid-lowering therapy in terms of ARR and OP of major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and all-cause mortality.</p><h3>Methods</h3><p>We searched PubMed, Embase, and prior reviews to identify trials comparing intensive versus standard lipid-lowering therapy for the risk of cardiovascular disease. We extracted the number of patients with MACE, MI, stroke, and all-cause mortality. Risk of bias was assessed according to the five domains of the Cochrane Risk of Bias Tool 2.0. We calculated ARRs and OPs to assess the clinical benefits of intensive versus standard therapy for each outcome. We conducted meta-analyses standardizing the results to 2 and 5 years of follow-up.</p><h3>Results</h3><p>We identified 11 double-blind, randomized, controlled trials (<i>n</i> = 101,357). The follow-up period ranged from 1.5 to 7.0 years, with an average follow-up duration of 3.7 years. Risk of bias was generally high. During an estimated 2 years of intensive versus standard lipid-lowering therapy, 1.1% (95% confidence interval [CI] 0.7–1.5) fewer patients had MACE and the OP of MACE was 4.1 days (95% CI 2.6–5.6). The effects were 0.7% (95% CI 0.4–0.8) and 2.5 days (95% CI 1.6–3.3) for MI, 0.2% (95% CI 0.1–0.3) and 0.9 days (95% CI 0.5–1.2) for stroke, and 0.2% (95% CI − 0.1 to 0.4) and 0.6 days (95% CI − 0.4 to 1.5) for all-cause death. During on average 5 years of intensive versus standard lipid-lowering therapy, 2.4% (95% CI 1.5–3.3) fewer patients had MACE and the time gained to MACE was 23.5 days (95% CI 14.9–32.0). The effects were 1.5% (95% CI 1.0–2.1) and 14.6 days (95% CI 9.3–20.0) for MI, 0.6% (95% CI 0.4–0.8) and 5.3 days (95% CI 3.3–7.4) for stroke, and 0.4% (95% CI −0.2 to 0.1) and 3.6 days (95% CI − 2.1 to 9.2) for all-cause death.</p><h3>Conclusion</h3><p>Intensive lipid-lowering therapy during 2 or 5 years did not lead to fewer deaths or lifetime gained, and the effects on MI and stroke were negligible. The largest effect was that MACE did not occur in two of 100 patients and was postponed 3–4 weeks after 5 years of intensive treatment. Given the small effect, patients should receive this information as part of shared decision making.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"743 - 752"},"PeriodicalIF":2.8,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00668-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981493","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}

{"title":"COVID-19 Diagnosis, Oral Anticoagulation, and Stroke Risk in Patients with Atrial Fibrillation","authors":"Lanting Yang,&nbsp;Shangbin Tang,&nbsp;Jingchuan Guo,&nbsp;Nico Gabriel,&nbsp;Walid F. Gellad,&nbsp;Utibe R. Essien,&nbsp;Jared W. Magnani,&nbsp;Inmaculada Hernandez","doi":"10.1007/s40256-024-00671-3","DOIUrl":"10.1007/s40256-024-00671-3","url":null,"abstract":"<div><h3>Background</h3><p>Coronavirus disease 2019 (COVID-19) has been associated with an increased risk of stroke. It remains unclear whether the risk of stroke associated with a diagnosis of COVID-19 differed with oral anticoagulation (OAC) use. The aim of this study was to evaluate the association between COVID-19 infection, OAC use, and stroke in patients with atrial fibrillation (AF).</p><h3>Methods</h3><p>A retrospective cohort study was conducted in individuals with established AF using data from Optum’s deidentified Clinformatics^® Data Mart Database. Cox proportional hazard models with time-dependent variables were employed to assess the association between possession of OAC, COVID-19 diagnosis in both inpatient and outpatient setting, and time to ischemic stroke.</p><h3>Results</h3><p>A total of 561,758 individuals aged 77 ± 10 were included in the study, with a mean follow up time of 1.3 years. OAC use was associated with a reduced stroke risk [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.82–0.88]. COVID-19 infection was associated with an increased risk of stroke (HR 2.11, 95% CI 1.87–2.38); this increased risk was particularly pronounced for patients diagnosed with an inpatient diagnosis of COVID-19 (HR 3.95, 95% CI 3.33–4.68). There was no significant interaction between OAC use and COVID-19 diagnosis (<i>p</i> value = 0.96). As a result, the relative increase in stroke risk associated with COVID-19 did not differ between patients on OAC (HR 2.12; 95% CI 1.71–2.62) and those not on OAC (HR 2.11; 95% CI 1.83–2.43).</p><h3>Conclusion</h3><p>In a nationwide sample of patients with established AF, we found the relative increase in stroke risk associated with COVID-19 was independent of OAC use.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 5","pages":"693 - 702"},"PeriodicalIF":2.8,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970430","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}

{"title":"Clinical Considerations for Healthcare Provider-Administered Lipid-Lowering Medications","authors":"Barry D. Bertolet,&nbsp;Katherine P. Cabral,&nbsp;Lance Sullenberger,&nbsp;Jan L. McAlister,&nbsp;Todd Sandroni,&nbsp;Dharmesh S. Patel","doi":"10.1007/s40256-024-00665-1","DOIUrl":"10.1007/s40256-024-00665-1","url":null,"abstract":"<div><p>Atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality and morbidity, is associated with a substantial healthcare and economic burden. Reduction of low-density lipoprotein cholesterol (LDL-C) to guideline-recommended goals is crucial in the prevention or management of ASCVD, particularly in those at high risk. Despite the availability of several effective lipid-lowering therapies (LLTs), up to 80% of patients with ASCVD do not reach evidence-based LDL-C goals. This nonattainment may be due to poor adherence to, and lack of timely utilization of, LLTs driven by a range of variables, including polypharmacy, side effects, clinical inertia, costs, and access issues. Inclisiran was approved by the US Food and Drug Administration in 2021 as a novel, twice-yearly, healthcare provider (HCP)-administered LLT. In-office administration allows HCPs more control of drug acquisition, administration, and reimbursement, and may allow for more timely care and increased patient monitoring. In the USA, in-office administered drugs are considered a Medical Benefit and can be acquired and reimbursed using the “buy-and-bill” process. Buy-and-bill is a standard system for medication administration already established in multiple therapeutic areas, including oncology, vaccines, and allergy/immunology. Initiating in-office administration will involve new considerations for clinicians in the cardiovascular specialty, such as the implementation of new infrastructure and processes; however, it could ultimately increase treatment adherence and improve cardiovascular outcomes for patients with ASCVD. This article discusses the potential implications of buy-and-bill for the cardiology specialty and provides a practical guide to implementing HCP-administered specialty drugs in US clinical practice.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 6","pages":"729 - 741"},"PeriodicalIF":2.8,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00665-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970429","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}

{"title":"Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data","authors":"Stephen R. Mandt,&nbsp;Noble Thadathil,&nbsp;Christian Klem,&nbsp;Cristina Russ,&nbsp;Patricia L. McNamee,&nbsp;Kevin Stigge,&nbsp;Dong Cheng","doi":"10.1007/s40256-024-00664-2","DOIUrl":"10.1007/s40256-024-00664-2","url":null,"abstract":"<div><p>Chronic kidney disease (CKD) remains a significant global health issue and is a leading cause of mortality worldwide. Patients with CKD have an increased risk of developing atrial fibrillation (AF) and venous thromboembolism (VTE). While direct oral anticoagulants (DOACs) have become a standard of care for anticoagulation (AC) in patients with AF and VTE, the appropriate use of these agents in comorbid kidney impairment warrants detailed discussion. This scientific narrative review summarizes the effectiveness and safety of apixaban use in patients with renal dysfunction by assessing the current published pharmacokinetic, interventional, observational, and guideline data. Apixaban is a highly selective, orally active, direct inhibitor of factor Xa, with well-established pharmacokinetics and consistent clinical outcomes across a broad range of patient populations, including those with kidney impairment. Overall, the scientific literature has shown that apixaban has a favorable clinical efficacy and safety profile compared with vitamin K antagonists for patients with AF or VTE and comorbid kidney impairment. These data support the approved label dosing strategy of apixaban in reducing the risk of stroke/systemic embolism in patients with nonvalvular AF and in treating VTE across all ranges of kidney function. Both clinician experience and knowledge of patient-specific factors may be required in the management of comorbid patients with advanced CKD or those requiring dialysis, as data on these patients are limited.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 5","pages":"603 - 624"},"PeriodicalIF":2.8,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344734/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888201","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}

{"title":"Characteristics and Impact of Randomized Trials on Drugs or Devices in Cardiovascular Medicine","authors":"Marco Spagnolo,&nbsp;Claudio Laudani,&nbsp;Antonio Greco,&nbsp;Daniele Giacoppo,&nbsp;Davide Capodanno","doi":"10.1007/s40256-024-00670-4","DOIUrl":"10.1007/s40256-024-00670-4","url":null,"abstract":"<div><h3>Introduction</h3><p>Clinical trials, essential for medical advancement, vary significantly in methodology and regulatory pathways depending on the type of therapeutic intervention (i.e., drugs or devices). This study aimed to determine whether the drug or device intervention types influence the impact of randomized trials in cardiovascular medicine.</p><h3>Methods</h3><p>We analyzed late-breaking randomized controlled trials presented at major cardiology conferences from 2015 to 2021. The primary endpoint was the total number of citations obtained. Secondary endpoints included the number of citations at 1 and 2 years, number of total and 1-year mentions, and several metrics of study conduct and publication. Statistical analysis included tests for comparisons of continuous or categorical variables, based on their distribution, as appropriate. To adjust the results for potential confounders, univariable and multivariable regression models were utilized. Additionally, sensitivity analyses were conducted to explore both the effect of neutral or positive study outcomes on the comparative impact of drug versus device trials and the impact of the coronavirus disease 2019 (COVID-19) pandemic on the primary endpoint.</p><h3>Results</h3><p>Of 382 eligible randomized trials, 227 (59.4%) were trials of drugs and 155 (40.6%) were trials of devices. Drug trials had a higher median number of total citations compared to device studies (93 [interquartile range {IQR} 48–137] vs. 82 [IQR 39–192]; <i>p</i> = 0.025). This difference was consistent at 1 and 2 years and was also observed in the number of total mentions and mentions at 1 year. All the metrics of study conduct and publication were similar, except for drug studies being more often stopped prematurely (8.8 vs. 1.9%; <i>p</i> = 0.006). After adjusting for multiple potential confounders, the difference in citations and mentions was no longer statistically significant. However, drug trials remained more likely to be stopped prematurely (adjusted odds ratio = 1.15; 95% confidence interval 1.03–1.28; <i>p</i> = 0.009). Positive study outcomes significantly influenced the number of citations and the likelihood of a trial being stopped prematurely.</p><h3>Conclusions</h3><p>Drug trials are often stopped early and receive more citations and mentions than device trials. However, these differences are mainly due to factors other than the treatment itself. Studies published simultaneously tend to get more attention, and drug trials with positive results are cited more often than those with neutral results.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 5","pages":"651 - 661"},"PeriodicalIF":2.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858803","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}

{"title":"Novel Cardiac Myosin Inhibitor Therapy for Hypertrophic Cardiomyopathy in Adults: A Contemporary Review","authors":"Jan K. Kalinski,&nbsp;Bo Xu,&nbsp;Ramone Boyd,&nbsp;Natalie Tasseff,&nbsp;Katy Rutkowski,&nbsp;Susan Ospina,&nbsp;Nicholas Smedira,&nbsp;Maran Thamilarasan,&nbsp;Zoran B. Popovic,&nbsp;Milind Y. Desai","doi":"10.1007/s40256-024-00667-z","DOIUrl":"10.1007/s40256-024-00667-z","url":null,"abstract":"<div><p>Hypertrophic cardiomyopathy (HCM) affects as many as 1 in 200 people in the adult population globally. Patients may present with exertional dyspnea, presyncope or syncope, atrial and ventricular arrhythmias, heart failure, and even sudden cardiac death. Current guideline-based therapy involves medical therapy for treatment of symptoms in milder forms of the disease and surgical or catheter-based septal reduction therapies in obstructive HCM. Until recently, there has existed a gap between these two approaches that is now being filled by a new class of drugs, cardiac myosin inhibitors, which directly target the underlying disease process in HCM. Current investigations examine the effects of two cardiac myosin inhibitors on reported symptoms, echocardiographic evidence of disease, and the associated need for septal reduction. This paper reviews the contemporary evidence for the use of cardiac myosin inhibitors in HCM in adults and highlights future directions for this exciting field of cardiovascular medicine.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"24 5","pages":"591 - 602"},"PeriodicalIF":2.8,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141726749","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}