Huang Chien-Yu, Overholser Brian R, Sowinski Kevin M, Jaynes Heather A, Kovacs Richard J, Tisdale James E
Department of Pharmacy Practice, College of Pharmacy, Purdue University, West Lafayette and Indianapolis, Indiana, USA.
Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.
JACC Adv. 2024 Nov 7;3(11):101354. doi: 10.1016/j.jacadv.2024.101354. eCollection 2024 Nov.
Heart failure (HF) with reduced ejection fraction (HFrEF) is a risk factor for drug-induced arrhythmias. It is unknown whether HF with preserved ejection fraction (HFpEF) also increases the risk.
The purpose of this study was to determine if the risk of ventricular tachycardia (VT) and sudden cardiac arrest (SCA) is increased in patients with HFpEF prescribed dofetilide or sotalol.
Using Medicare claims and pharmacy benefits from 2014 to 2016, we identified patients taking dofetilide or sotalol and non-dofetilide/sotalol users among 3 groups: HFrEF (n = 26,176), HFpEF (n = 33,304), and no HF (n = 580,249). Multinomial propensity score matching was performed. We compared baseline characteristics using Cochran-Mantel-Haenszel statistics and standardized differences, and tested associations of VT and SCA among dofetilide/sotalol users and those with HFpEF, HFrEF, or no HF using a generalized Cox proportional hazards model.
VT and SCA occurred 166 (10.68%) and 16 (1.03%) of 1,554 dofetilide/sotalol users with HFpEF, 543 (38.76%) and 40 (2.86%) of 1,401 dofetilide/sotalol users with HFrEF, and 245 (5.06%) and 13 (0.27%) of 4,839 dofetilide/sotalol users without HF. Overall VT risk was increased in HFrEF and HFpEF patients (HR: 7.00 [95% CI: 6.10-8.02] and 1.99 [95% CI: 1.70-2.32], respectively). The risk of VT in patients prescribed dofetilide/sotalol was increased in HFrEF and HFpEF patients (1.53 [95% CI: 1.07-2.20] and 2.34 [95% CI: 1.11-4.95], respectively). While the overall SCA risk was increased in HFrEF and HFpEF patients (5.19 [95% CI: 4.10-6.57] and 2.53 [95% CI: 1.98-3.23], respectively), dofetilide/sotalol use was not associated with an increased SCA risk.
In patients with HF who are prescribed dofetilide or sotalol, the risk of VT, but not SCA, was increased.
射血分数降低的心力衰竭(HFrEF)是药物性心律失常的一个危险因素。射血分数保留的心力衰竭(HFpEF)是否也会增加风险尚不清楚。
本研究的目的是确定在使用多非利特或索他洛尔的HFpEF患者中,室性心动过速(VT)和心脏性猝死(SCA)的风险是否增加。
利用2014年至2016年的医疗保险理赔和药房福利数据,我们在三组人群中识别出使用多非利特或索他洛尔的患者以及未使用多非利特/索他洛尔的患者:HFrEF(n = 26,176)、HFpEF(n = 33,304)和无心力衰竭(n = 580,249)。进行了多项倾向评分匹配。我们使用 Cochr an-Mantel-Haenszel 统计量和标准化差异比较基线特征,并使用广义 Cox 比例风险模型测试多非利特/索他洛尔使用者与 HFpEF、HFrEF 或无心力衰竭患者中 VT 和 SCA 的关联。
在1554例使用多非利特/索他洛尔的HFpEF患者中,发生VT和SCA的分别有166例(10.68%)和16例(1.03%);在1401例使用多非利特/索他洛尔的HFrEF患者中,发生VT和SCA的分别有543例(38.76%)和40例(2.86%);在4839例使用多非利特/索他洛尔的无心力衰竭患者中,发生VT和SCA的分别有245例(5.06%)和13例(0.27%)。HFrEF和HFpEF患者的总体VT风险增加(HR分别为:7.00 [95% CI:6.10 - 8.02]和1.99 [95% CI:1.70 - 2.32])。使用多非利特/索他洛尔的HFrEF和HFpEF患者发生VT的风险增加(分别为1.53 [95% CI:1.07 - 2.20]和2.34 [95% CI:1.11 - 4.95])。虽然HFrEF和HFpEF患者的总体SCA风险增加(分别为5.19 [95% CI:4.10 - 6.57]和2.53 [95% CI:1.98 - 3.23]),但使用多非利特/索他洛尔与SCA风险增加无关。
在使用多非利特或索他洛尔的心力衰竭患者中,VT风险增加,但SCA风险未增加。