{"title":"Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF","authors":"","doi":"10.1016/j.jchf.2024.04.018","DOIUrl":"10.1016/j.jchf.2024.04.018","url":null,"abstract":"<div><h3>Background</h3><p>The efficacy of sotagliflozin<span> in patients with diabetes and recent worsening of heart failure was shown in the SOLOIST-WHF trial. However, the cost-effectiveness of sotagliflozin in these patients has not been previously investigated.</span></p></div><div><h3>Objectives</h3><p>The authors sought to determine the cost-effectiveness of sotagliflozin in patients with diabetes and recent worsening of heart failure.</p></div><div><h3>Methods</h3><p><span>Based on SOLOIST-WHF trial data (N = 1,222), the authors constructed a Markov model to estimate the lifetime impact of sotagliflozin from a U.S. health care sector perspective. Cost data were sourced from the National Inpatient Sample. Life expectancy was modeled from census data and modified by the </span>mortality rate in SOLOIST-WHF. Fatal and nonfatal event rates were carried forward from the trial data. Utility was assessed from the published reports.</p></div><div><h3>Results</h3><p>Lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in the sotagliflozin and placebo groups, respectively, and lifetime costs were $220,113 and $188,198 in the sotagliflozin and placebo groups, respectively. The point estimate incremental cost-effectiveness ratio was $81,823 per QALY gained. The probability of being cost-effective was 3.6%, 67.5%, and 89.4% at willingness-to-pay thresholds of $50,000, $100,000, and $150,000, respectively, per QALY gained.</p></div><div><h3>Conclusions</h3><p><span>In patients with diabetes and recent worsening of heart failure, sotagliflozin is cost-effective in the U.S. using commonly accepted willingness-to-pay thresholds. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; </span><span><span>NCT03521934</span><svg><path></path></svg></span>)</p></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1600-1610"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327450","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":"Titration of Medications After Acute Heart Failure Is Safe, Tolerated, and Effective Regardless of Risk","authors":"","doi":"10.1016/j.jchf.2024.04.017","DOIUrl":"10.1016/j.jchf.2024.04.017","url":null,"abstract":"<div><h3>Background</h3><p>Guideline-directed medical therapy (GDMT) decisions may be less affected by single patient variables such as blood pressure or kidney function and more by overall risk profile. In STRONG-HF (Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure), high-intensity care (HIC) in the form of rapid uptitration of heart failure (HF) GDMT was effective overall, but the safety, tolerability and efficacy of HIC across the spectrum of HF severity is unknown. Evaluating this with a simple risk-based framework offers an alternative and more clinically translatable approach than traditional subgroup analyses.</p></div><div><h3>Objectives</h3><p>The authors sought to assess safety, tolerability, and efficacy of HIC according to the simple, powerful, and clinically translatable MAGGIC (Meta-Analysis Global Group in Chronic) HF risk score.</p></div><div><h3>Methods</h3><p>In STRONG-HF, 1,078 patients with acute HF were randomized to HIC (uptitration of treatments to 100% of recommended doses within 2 weeks of discharge and 4 scheduled outpatient visits over the 2 months after discharge) vs usual care (UC). The primary endpoint was the composite of all-cause death or first HF rehospitalization at day 180. Baseline HF risk profile was determined by the previously validated MAGGIC risk score. Treatment effect was stratified according to MAGGIC risk score both as a categorical and continuous variable.</p></div><div><h3>Results</h3><p>Among 1,062 patients (98.5%) with complete data for whom a MAGGIC score could be calculated at baseline, GDMT use at baseline was similar across MAGGIC tertiles. Overall GDMT prescriptions achieved for individual medication classes were higher in the HIC vs UC group and did not differ by MAGGIC risk score tertiles (interaction nonsignificant). The incidence of all-cause death or HF readmission at day 180 was, respectively, 16.3%, 18.9%, and 23.2% for MAGGIC risk score tertiles 1, 2, and 3. The HIC arm was at lower risk of all-cause death or HF readmission at day 180 (HR: 0.66; 95% CI: 0.50-0.86) and this finding was robust across MAGGIC risk score modeled as a categorical (HR: 0.51; 95% CI: 0.62-0.68 in tertiles 1, 2, and 3; interaction nonsignificant) for all comparisons and continuous (interaction nonsignificant) variable. The rate of adverse events was higher in the HIC group, but this observation did not differ based on MAGGIC risk score tertile (interaction nonsignificant).</p></div><div><h3>Conclusions</h3><p>HIC led to better use of GDMT and lower HF-related morbidity and mortality compared with UC, regardless of the underlying HF risk profile. (Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies [STRONG-HF]; <span><span>NCT03412201</span><svg><path></path></svg></span>)</p></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1566-1582"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140911784","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":"DOAC Use in Durable Mechanical Circulatory Support","authors":"Sean P. Pinney MD","doi":"10.1016/j.jchf.2024.07.012","DOIUrl":"10.1016/j.jchf.2024.07.012","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1550-1552"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142128236","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":"Dapagliflozin and Timing of Prior Heart Failure Hospitalization","authors":"","doi":"10.1016/j.jchf.2024.01.018","DOIUrl":"10.1016/j.jchf.2024.01.018","url":null,"abstract":"<div><h3>Background</h3><p>Patients recently hospitalized for heart failure (HF) are at a higher risk of adverse clinical outcomes, but they may experience a greater absolute and relative benefit from effective therapies than individuals who are considered more “stable.”</p></div><div><h3>Objectives</h3><p>The authors examined the effects of dapagliflozin according to the timing of prior HF hospitalization in a patient-level pooled analysis of DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure).</p></div><div><h3>Methods</h3><p>A total of 11,007 patients were randomized in DAPA-HF and DELIVER. The primary outcome was the composite of worsening HF or cardiovascular death.</p></div><div><h3>Results</h3><p>In total, 12.4% were hospitalized for HF within 3 months of randomization, 14.2% between 3 and 12 months, and 16.8% more than 1 year before randomization, whereas 56.5% had not been hospitalized. The risk of the primary endpoint was inversely associated with time from prior HF hospitalization, and patients with a recent HF hospitalization had the highest risk. Compared with placebo, dapagliflozin reduced the risk of the primary outcome across HF hospitalization category (0-3 months, HR: 0.66 [95% CI: 0.55-0.81]; 3-12 months, HR: 0.73 [95% CI: 0.59-0.90]; >1 year, HR: 0.91 [95% CI: 0.74-1.12]; and no prior hospitalization, HR: 0.83 [95% CI: 0.73-0.94]; <em>P</em><sub>interaction</sub> = 0.09). The number of patients needed to treat with dapagliflozin to prevent 1 event over the median follow-up of 22 months was 13, 20, 23, and 28, respectively. The beneficial effect was consistent across the range of LVEF regardless of HF hospitalization category.</p></div><div><h3>Conclusions</h3><p>The relative benefits of dapagliflozin were consistent across the range of LVEF regardless of the timing of the most recent HF hospitalization with a greater absolute benefit in patients with recent hospitalization.</p></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1586-1599"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213177924001495/pdfft?md5=b0bcb9df6af7df567d9012ad8bc6c366&pid=1-s2.0-S2213177924001495-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849083","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}
Emily P. Zeitler MD, MHS , Amber E. Johnson MD, MS, MBA , Lauren B. Cooper MD, MHS , Benjamin A. Steinberg MD, MHS , Brian A. Houston MD
{"title":"Atrial Fibrillation and Heart Failure With Reduced Ejection Fraction","authors":"Emily P. Zeitler MD, MHS , Amber E. Johnson MD, MS, MBA , Lauren B. Cooper MD, MHS , Benjamin A. Steinberg MD, MHS , Brian A. Houston MD","doi":"10.1016/j.jchf.2024.06.016","DOIUrl":"10.1016/j.jchf.2024.06.016","url":null,"abstract":"<div><p>Atrial fibrillation (AF) and heart failure (HF)—specifically, heart failure with reduced ejection fraction (HFrEF)—often coexist, and each contributes to the propagation of the other. This relationship extends from the mechanistic and physiological to clinical syndromes, quality of life, and long-term cardiovascular outcomes. The risk factors for AF and HF overlap and create a critical opportunity to prevent adverse outcomes among patients at greatest risk for either condition. Increasing recognition of the linkages between AF and HF have led to widespread interest in designing diagnostic, predictive, and interventional strategies targeting all aspects of disease, from identifying genetic predisposition to addressing social determinants of health. Advances across this spectrum culminated in updated multisociety guidelines for management of AF, which includes specific consideration of comorbid AF and HF. This review expands on these guidelines by further highlighting relevant clinical trial findings and providing additional context for the evolving recommendations for management in this important and growing population.</p></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1528-1539"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995750","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}
Jennifer T. Thibodeau MD, MSCS , Michael M. Givertz MD
{"title":"Rapid Uptitration of Guideline-Directed Medical Therapy Regardless of Risk","authors":"Jennifer T. Thibodeau MD, MSCS , Michael M. Givertz MD","doi":"10.1016/j.jchf.2024.05.028","DOIUrl":"10.1016/j.jchf.2024.05.028","url":null,"abstract":"","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1583-1585"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633535","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}
Joycie Chang, Andrew P Ambrosy, Orly Vardeny, Harriette G C Van Spall, Robert J Mentz, Andrew J Sauer
{"title":"Mineralocorticoid Antagonism in Heart Failure: Established and Emerging Therapeutic Role.","authors":"Joycie Chang, Andrew P Ambrosy, Orly Vardeny, Harriette G C Van Spall, Robert J Mentz, Andrew J Sauer","doi":"10.1016/j.jchf.2024.08.007","DOIUrl":"https://doi.org/10.1016/j.jchf.2024.08.007","url":null,"abstract":"<p><p>The pathophysiology of heart failure (HF) is related to the overactivation of the mineralocorticoid receptor, leading to fluid retention and adverse myocardial remodeling. Although mineralocorticoid receptor antagonists (MRAs) are recommended for the treatment of heart failure with reduced ejection fraction (HFrEF), they remain underused due to adverse effects such as hyperkalemia; and their efficacy is controversial in heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF). Recent trials in people with diabetes and kidney disease have supported the use of nonsteroidal MRAs in reducing HF-related morbidity and mortality and have fewer side effects than their steroidal counterparts. The efficacy and safety of nonsteroidal MRAs have not been tested in HF and are currently being evaluated in additional clinical trials. This review comprehensively examines the current data regarding MRAs for HF and the future direction of nonsteroidal MRA research while exploring the causes of MRA underutilization.</p>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145666","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":"Heart Failure Risk Among African-American Women With an ICAM1 Missense Variant","authors":"","doi":"10.1016/j.jchf.2024.02.002","DOIUrl":"10.1016/j.jchf.2024.02.002","url":null,"abstract":"<div><h3>Background</h3><p><span>A common genetic variant of </span><em>ICAM1</em> among African-American individuals (rs5491; <em>p.K56M</em><span>) is associated with heart failure (HF) hospitalization, but whether this risk is specific to heart failure with preserved ejection fraction (HFpEF) remains unclear. Older women are at high risk for HFpEF, and the relationship between rs5491 and HFpEF across the age spectrum is unknown.</span></p></div><div><h3>Objectives</h3><p>This study assessed risk of HF and its subtypes conferred by <em>ICAM1 p.K56M</em> (rs5491).</p></div><div><h3>Methods</h3><p>Associations of rs5491 with risk of HF and its subtypes were estimated among African American individuals in WHI (Women’s Health Initiative). The study evaluated whether the association between rs5491 and HF hospitalizations was modified by baseline age. Subsequently, African-American women in WHI and MESA (Multi-Ethnic Study of Atherosclerosis) were pooled and analyses were repeated.</p></div><div><h3>Results</h3><p><span>Among 8,401 women in WHI, the minor allele frequency of rs5491 was 20.7%, and 731 HF hospitalizations occurred over 19.2 years. The rs5491 variant was not associated with HF or its subtypes across WHI. Interaction analyses suggested that age as a continuous variable modified the association of rs5491 with HFpEF hospitalization (interaction </span><em>P =</em> 0.04). Upon categorizing women into age decades, rs5491 conferred increased risk of HFpEF among women ≥70 years (HR per additional rs5491 allele: 1.82 [95% CI: 1.25-2.65]; <em>P =</em> 0.002) but was not associated with HFpEF risk among women <70 years. Pooling African-American women in WHI (n = 8,401) and MESA (n = 856) demonstrated that the effect modification by age on the association of rs5491 with HFpEF became more significant (interaction <em>P =</em> 0.009), with consistent HFpEF risk effect estimates among women ≥70 years.</p></div><div><h3>Conclusions</h3><p><em>ICAM1 p.K56M</em> (rs5491) is associated with HFpEF among African-American women ≥70 years.</p></div>","PeriodicalId":14687,"journal":{"name":"JACC. Heart failure","volume":"12 9","pages":"Pages 1614-1624"},"PeriodicalIF":10.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140293515","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}