Francisca Augusto, Patrícia Paiva, Carolina Félix, Inês Jordão, Miguel Costa, Patrícia Dias, Francisco Parente, Lino Gonçalves, Francisco Machado, Natália António
{"title":"达格列净对心力衰竭伴射血分数降低的影响:一项现实世界研究。","authors":"Francisca Augusto, Patrícia Paiva, Carolina Félix, Inês Jordão, Miguel Costa, Patrícia Dias, Francisco Parente, Lino Gonçalves, Francisco Machado, Natália António","doi":"10.1002/jcph.70082","DOIUrl":null,"url":null,"abstract":"<p><p>Dapagliflozin has demonstrated multiple benefits in clinical trials for heart failure with reduced ejection fraction (HFrEF), but older patients with multiple comorbidities were often excluded. This study aimed to evaluate the effectiveness and safety of dapagliflozin in a real-world population of HFrEF patients. This retrospective study included HFrEF patients from a tertiary hospital, who initiated dapagliflozin between January 202 and December 2022. The mean follow-up was 15.3 ± 8.3 months. Each patient served as their own control to compare left ventricular ejection fraction (LVEF), laboratory parameters, and time-dependent events, such as heart failure (HF) readmissions. A total of 155 HFrEF patients (mean age 68.5 ± 14.5 years; 75.5% male) were included. Of these, 47.1% had non-ischemic heart disease, 49.0% had type 2 diabetes mellitus, and most were on beta-blockers, loop diuretics and angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or angiotensin receptor neprilysin inhibitor. LVEF improved from 29.2% to 34.3% (P < .001), with significant reductions in body weight and heart rate (P < .001). HF-related emergency room visits decreased (0.68 ± 1.06 to 0.58 ± 0.96; P = .329). Renal function declined, with glomerular filtration rate decreasing from 67.6 ± 25.2 to 55.2 ± 30.8 mL/min/1.73 m<sup>2</sup> (P < .001), particularly in older patients (HR 1.033; 95% CI: 1.004-1.063) and those with higher baseline heart rate (HR 1.028; 95% CI: 1.011-1.045). Severe adverse drug reactions occurred in 3.9% of patients, with hypotension (12.9%) being the most common. In conclusion, dapagliflozin demonstrated a favorable safety profile and significant hemodynamic benefits, improving LVEF and stabilizing HF progression in a real-world HFrEF population.</p>","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of Dapagliflozin on Heart Failure with Reduced Ejection Fraction: A Real-World Study.\",\"authors\":\"Francisca Augusto, Patrícia Paiva, Carolina Félix, Inês Jordão, Miguel Costa, Patrícia Dias, Francisco Parente, Lino Gonçalves, Francisco Machado, Natália António\",\"doi\":\"10.1002/jcph.70082\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Dapagliflozin has demonstrated multiple benefits in clinical trials for heart failure with reduced ejection fraction (HFrEF), but older patients with multiple comorbidities were often excluded. This study aimed to evaluate the effectiveness and safety of dapagliflozin in a real-world population of HFrEF patients. This retrospective study included HFrEF patients from a tertiary hospital, who initiated dapagliflozin between January 202 and December 2022. The mean follow-up was 15.3 ± 8.3 months. Each patient served as their own control to compare left ventricular ejection fraction (LVEF), laboratory parameters, and time-dependent events, such as heart failure (HF) readmissions. A total of 155 HFrEF patients (mean age 68.5 ± 14.5 years; 75.5% male) were included. Of these, 47.1% had non-ischemic heart disease, 49.0% had type 2 diabetes mellitus, and most were on beta-blockers, loop diuretics and angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or angiotensin receptor neprilysin inhibitor. LVEF improved from 29.2% to 34.3% (P < .001), with significant reductions in body weight and heart rate (P < .001). HF-related emergency room visits decreased (0.68 ± 1.06 to 0.58 ± 0.96; P = .329). Renal function declined, with glomerular filtration rate decreasing from 67.6 ± 25.2 to 55.2 ± 30.8 mL/min/1.73 m<sup>2</sup> (P < .001), particularly in older patients (HR 1.033; 95% CI: 1.004-1.063) and those with higher baseline heart rate (HR 1.028; 95% CI: 1.011-1.045). Severe adverse drug reactions occurred in 3.9% of patients, with hypotension (12.9%) being the most common. In conclusion, dapagliflozin demonstrated a favorable safety profile and significant hemodynamic benefits, improving LVEF and stabilizing HF progression in a real-world HFrEF population.</p>\",\"PeriodicalId\":48908,\"journal\":{\"name\":\"Journal of Clinical Pharmacology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/jcph.70082\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/jcph.70082","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Impact of Dapagliflozin on Heart Failure with Reduced Ejection Fraction: A Real-World Study.
Dapagliflozin has demonstrated multiple benefits in clinical trials for heart failure with reduced ejection fraction (HFrEF), but older patients with multiple comorbidities were often excluded. This study aimed to evaluate the effectiveness and safety of dapagliflozin in a real-world population of HFrEF patients. This retrospective study included HFrEF patients from a tertiary hospital, who initiated dapagliflozin between January 202 and December 2022. The mean follow-up was 15.3 ± 8.3 months. Each patient served as their own control to compare left ventricular ejection fraction (LVEF), laboratory parameters, and time-dependent events, such as heart failure (HF) readmissions. A total of 155 HFrEF patients (mean age 68.5 ± 14.5 years; 75.5% male) were included. Of these, 47.1% had non-ischemic heart disease, 49.0% had type 2 diabetes mellitus, and most were on beta-blockers, loop diuretics and angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or angiotensin receptor neprilysin inhibitor. LVEF improved from 29.2% to 34.3% (P < .001), with significant reductions in body weight and heart rate (P < .001). HF-related emergency room visits decreased (0.68 ± 1.06 to 0.58 ± 0.96; P = .329). Renal function declined, with glomerular filtration rate decreasing from 67.6 ± 25.2 to 55.2 ± 30.8 mL/min/1.73 m2 (P < .001), particularly in older patients (HR 1.033; 95% CI: 1.004-1.063) and those with higher baseline heart rate (HR 1.028; 95% CI: 1.011-1.045). Severe adverse drug reactions occurred in 3.9% of patients, with hypotension (12.9%) being the most common. In conclusion, dapagliflozin demonstrated a favorable safety profile and significant hemodynamic benefits, improving LVEF and stabilizing HF progression in a real-world HFrEF population.
期刊介绍:
The Journal of Clinical Pharmacology (JCP) is a Human Pharmacology journal designed to provide physicians, pharmacists, research scientists, regulatory scientists, drug developers and academic colleagues a forum to present research in all aspects of Clinical Pharmacology. This includes original research in pharmacokinetics, pharmacogenetics/pharmacogenomics, pharmacometrics, physiologic based pharmacokinetic modeling, drug interactions, therapeutic drug monitoring, regulatory sciences (including unique methods of data analysis), special population studies, drug development, pharmacovigilance, womens’ health, pediatric pharmacology, and pharmacodynamics. Additionally, JCP publishes review articles, commentaries and educational manuscripts. The Journal also serves as an instrument to disseminate Public Policy statements from the American College of Clinical Pharmacology.