Department of Medicine, Tulane University School of Medicine, New Orleans, LA, USA.
Health Promotion and Disease Prevention, Emory University, Atlanta, GA, USA.
J Clin Lipidol. 2019 Jul-Aug;13(4):586-593.e5. doi: 10.1016/j.jacl.2019.06.002. Epub 2019 Jun 27.
BACKGROUND: Differences in lipid and cardiovascular risk profiles have been observed in African-American/black (AA/B), white (W), and Hispanic/Latino (H/L) individuals. Efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, may vary by race and ethnicity and has not been analyzed. OBJECTIVE: This post hoc analysis evaluated alirocumab efficacy and safety vs control in 3 pooled ODYSSEY phase 3 trials (COMBO I, COMBO II, and LONG TERM) by race (AA/B [n = 154] vs W [n = 1982]) and ethnicity (H/L [n = 174] vs non-H/L [n = 3149]). METHODS: Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin received alirocumab (75 mg up to 150 mg every 2 weeks [COMBO I & II] or 150 mg every 2 weeks [LONG TERM]) or control (placebo [COMBO I and LONG TERM] or ezetimibe [COMBO II]). RESULTS: At baseline, LDL-C levels were similar across treatment groups; median lipoprotein(a) levels were higher in AA/B (33.0-120.0 mg/dL) vs W (7.1-66.3 mg/dL) and lower in H/L (5.0-38.3 mg/dL) vs non-H/L (7.7-69.0 mg/dL). At week 24, alirocumab significantly reduced LDL-C vs control. Alirocumab also reduced lipoprotein(a) compared with control across the subgroups. Treatment-emergent adverse events were similar between alirocumab (68.9-85.0%) and control (70.6-82.4%) regardless of race and ethnicity. CONCLUSION: Alirocumab significantly reduced LDL-C and Lp(a) levels compared with control, regardless of race and ethnicity, with overall safety comparable to control across most of the racial and ethnic groups analyzed.
背景：在非裔美国人/黑人（AA/B）、白种人（W）和西班牙裔/拉丁裔（H/L）个体中，观察到脂质和心血管风险特征存在差异。前蛋白转化酶枯草溶菌素/克那霉 9 抑制剂阿利西尤单抗的疗效和安全性可能因种族和民族而异，尚未进行分析。 目的：这项事后分析评估了阿利西尤单抗在 3 项 ODYSSEY 阶段 3 联合研究（COMBO I、COMBO II 和 LONG TERM）中的疗效和安全性，根据种族（AA/B[ n=154] vs W[ n=1982]）和民族（H/L[ n=174] vs 非 H/L[ n=3149]）进行分层。 方法：接受最大耐受剂量他汀类药物治疗后低密度脂蛋白胆固醇（LDL-C）仍升高的患者接受阿利西尤单抗（75 mg 增至 150 mg，每 2 周 1 次[COMBO I 和 COMBO II]或每 2 周 150 mg[LONG TERM]）或对照治疗（COMBO I 和 LONG TERM 组安慰剂；COMBO II 组依折麦布）。 结果：基线时，各治疗组的 LDL-C 水平相似；AA/B 患者的脂蛋白（a）中位数水平更高（33.0-120.0 mg/dL），W 患者的水平更低（7.1-66.3 mg/dL），H/L 患者的水平更低（5.0-38.3 mg/dL），非 H/L 患者的水平更低（7.7-69.0 mg/dL）。治疗 24 周时，与对照相比，阿利西尤单抗显著降低 LDL-C。与对照相比，阿利西尤单抗还降低了各亚组的脂蛋白（a）。无论种族和民族如何，阿利西尤单抗（68.9-85.0%）和对照（70.6-82.4%）治疗中出现的不良事件相似。 结论：与对照相比，阿利西尤单抗显著降低 LDL-C 和 Lp（a）水平，无论种族和民族如何，在分析的大多数种族和民族群体中，总体安全性与对照相当。
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