https://scholars.lib.ntu.edu.tw/handle/123456789/587243
標題: | The characteristics and outcomes of patients with heart failure and reduced ejection fraction: The eligibility of novel heart failure medications | 作者: | Fong, Man Cai Chang, Hung Yu CHUN-CHIEH WANG Feng, An Ning Lin, Wei Shiang YEN-WEN WU Sung, Shih Hsien Huang, Jin Long Kuo, Jen Yuan Yin, Wei Hsian |
關鍵字: | Guidelines | Heart failure | Ivabradine | Left ventricular ejection fraction | Sacubitril/valsartan | Taiwan | 公開日期: | 1-七月-2021 | 卷: | 37 | 期: | 4 | 來源出版物: | Acta Cardiologica Sinica | 摘要: | Background: Renin-angiotensin system inhibitors and beta-blockers are the initial treatment of choice for heart failure with reduced ejection fraction (HFrEF), whereas sacubitril/valsartan (SAC/VAL) and ivabradine are considered to second-line therapies. The eligibility of SAC/VAL and ivabradine according to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) labels, Taiwan National Health Insurance (TNHI) reimbursement regulations, and European Society of Cardiology (ESC) heart failure (HF) guidelines are diverse, and they may not fulfill the needs of real-world HFrEF patients. Methods: Patients hospitalized for HF with left ventricular ejection fraction (LVEF) ≤ 40% were recruited from 21 hospitals in Taiwan between 2013 and 2014. The criteria for SAC/VAL and ivabradine according to the different regulations were applied. Results: Of 1,474 patients, 86.8%, 29.4%, and 9.5% met the EMA/FDA label criteria, TNHI-regulation, and ESC guidelines for SAC/VAL, compared to 47.1%, 37.2%, and 45.6% for ivabradine, respectively. Ineligible reasons for the TNHI regulations included LVEF > 35% (19.9%, for SAC/VAL and ivabradine) and sinus rate < 75 beats per minute (bpm) (29.9%, for ivabradine). Although not meeting the TNHI regulations, patients with LVEF 35-40% had a similar 1-year mortality rate (15.6% vs. 15.8%, p = 0.876) to those with LVEF ≤ 35%, whereas patients with a sinus rate 70-74 bpm had a similar 1-year mortality rate (15.3% vs. 16.1%, p = 0.805) to those with a sinus rate ≥ 75 bpm. Conclusions: Approximately 70% and 63% of TSOC-HFrEF registry patients were ineligible for SAC/VAL and ivabradine, respectively, according to current TNHI regulations. Regardless of the eligibility for novel HFrEF medications, the high incidence of adverse events suggests that all patients should be treated cautiously. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/587243 | ISSN: | 10116842 | DOI: | 10.6515/ACS.202107_37(4).20201223A |
顯示於: | 醫學院附設醫院 (臺大醫院) |
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