Lipid Clinic, Oslo University Hospital, Oslo, Norway.
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, ON, Canada.
Diab Vasc Dis Res. 2020 Nov-Dec;17(6):1479164120975256. doi: 10.1177/1479164120975256.
It is well established that higher low-density lipoprotein (LDL)-cholesterol levels are associated with increased cardiovascular risk. We analyzed whether effects of empagliflozin on cardiovascular outcomes varied by different LDL-cholesterol levels at baseline in EMPA-REG OUTCOME.
Participants with type 2 diabetes and high cardiovascular risk received empagliflozin (10/25 mg) or placebo in addition to standard of care. We investigated the time to first 3P-MACE, cardiovascular death, hospitalization for heart failure (HHF) and all-cause mortality for empagliflozin versus placebo between baseline LDL-cholesterol categories <1.8, 1.8-<2.2, 2.2- <2.6, 2.6-3.0, and > 3.0 mmol/L, by a Cox regression including the interaction of baseline LDL-cholesterol category and treatment.
Of the 7020 participants randomized and treated, 81.0% received lipid lowering therapy (77.0% statins). Mean ± SD LDL-cholesterol was 2.2 ± 0.9 mmol/L, and 38%/18%, had LDL-cholesterol <1.8/>3.0 mmol/L. Age, BMI, and HbA1c levels were balanced between the LDL-cholesterol subgroups, but those in the lowest versus highest group, had more coronary artery disease (83.0% vs 59.9%) and statin treatment (88.2% vs 50.9%). Empagliflozin consistently reduced all outcomes across LDL-cholesterol categories (all interaction -values > 0.05).
The beneficial cardiovascular effects of empagliflozin was consistent across higher and lower LDL-cholesterol levels at baseline.
众所周知，低密度脂蛋白（LDL）-胆固醇水平升高与心血管风险增加相关。我们分析了在 EMPA-REG OUTCOME 中，依帕列净对心血管结局的影响是否因基线时不同的 LDL-胆固醇水平而有所不同。
将患有 2 型糖尿病和高心血管风险的患者随机分为依帕列净（10/25mg）或安慰剂组，并接受标准治疗。我们通过 Cox 回归分析，比较了依帕列净与安慰剂组在基线 LDL-胆固醇<1.8、1.8-<2.2、2.2-<2.6、2.6-3.0 和>3.0mmol/L 五个类别之间，首次发生 3P-MACE、心血管死亡、因心力衰竭住院（HHF）和全因死亡率的时间。该回归模型包括了基线 LDL-胆固醇类别和治疗的交互作用。
在 7020 名随机和治疗的患者中，81.0%接受了降脂治疗（77.0%为他汀类药物）。平均±标准差 LDL-胆固醇为 2.2±0.9mmol/L，38%/18%的患者 LDL-胆固醇<1.8/>3.0mmol/L。年龄、BMI 和 HbA1c 水平在 LDL-胆固醇亚组之间平衡，但在最低和最高亚组之间，前者有更多的冠心病（83.0% vs 59.9%）和他汀类药物治疗（88.2% vs 50.9%）。依帕列净在所有 LDL-胆固醇类别中均一致降低了所有结局（所有交互 P 值>0.05）。
依帕列净的心血管获益效应在基线时较高和较低的 LDL-胆固醇水平下是一致的。
