老年高危心血管病患者应用依洛尤单抗的有效性及安全性研究

Efficacy and safety of evolocumab in elderly patients with high-risk cardiovascular diseases

目的探讨老年高危心血管病患者应用依洛尤单抗治疗的有效性和安全性。方法纳入2019年11月至2022年11月在解放军总医院第一、二、六、八医学中心心内科住院的经常规他汀类药物治疗后血脂控制不达标的心血管病高危患者153例,根据患者年龄分为非老年组(<60岁)46例,60~74岁老年组66例,≥75岁老年组41例,均按指南应用依洛尤单抗治疗;选取同期在解放军总医院第一、二、六、八医学中心心内科住院血脂控制不达标的年龄≥75岁心血管病高危未应用依洛尤单抗患者50例为常规治疗组,应用一种他汀类药物联合依折麦布治疗。比较各组患者临床基线资料及用药第4、12周的血液指标和12周内药物不良反应及主要不良心血管事件(MACE)发生情况。结果非老年组、60~74岁老年组和≥75岁老年组用药第4、12周低密度脂蛋白胆固醇(LDL-C)和总胆固醇(TC)水平较基线降低,差异有统计学意义(P<0.05,P<0.01);3组用药第12周LDL-C、TC水平比较无显著差异(P>0.05)。非老年组、60~74岁老年组、≥75岁老年组用药12周内不良事件发生率比较无显著差异(2.2%vs 3.0%vs 2.4%,P>0.05)。≥75岁老年组和常规治疗组用药第12周LDL-C、TC水平显著低于基线(P<0.05,P>0.01);≥75岁老年组用药第12周LDL-C水平显著低于常规治疗组[(1.36±0.44)mmol/L vs(1.87±0.56)mmol/L,P<0.01]。≥75岁老年组和常规治疗组用药12周内MACE发生率比较无显著差异(12.2%vs 16.0%,P>0.05),2组生存率比较无显著差异(P=0.576)。结论各年龄组患者应用依洛尤单抗治疗均可在短期内取得良好疗效,75岁以上老年患者应用依洛尤单抗治疗同样具有良好的有效性和安全性。

Objective To explore the efficacy and safety of evolocumab in elderly patients with high-risk cardiovascular diseases.Methods A total of 153 patients with poor lipid control after conventional statin therapy who were hospitalized in the cardiologic departments in the First,Second,Sixth and Eighth Medical Centers of Chinese PLA General Hospital from November 2019 to November 2022 were included,and divided into non-elderly group(<60 years old,46 cases),elderly group(60-74 years old,66 case)and very elderly group(≥75 years old,41 cases).They were all given evolocumab treatment according to guidelines.Another 50 over-75-year-old patients with high-risk cardiovascular diseases and poor lipid control who were hospitalized in the above cardiologic departments during the same period were treated with a statin drug combined with ezetimibe,and served as conventional treatment group(control group).The baseline clinical data and the blood indicators at 4th and 12th week after drug administration,and the occurrence of adverse drug reactions and major adverse cardiovascular events(MACE)within 12 weeks were compared among the groups.Results The levels of LDL-C and TC were significantly decreased in the three evolocumab treatment groups at 4 and 12 weeks after medication when compared with the baseline values(P<0.05,P<0.01),but there were no obvious differences in the 2 levels among the 3 groups at 12 weeks(P>0.05).At the time point,no statistical difference was observed in the incidence of adverse events in the three groups(2.2%vs 3.0%vs 2.4%,P>0.05).The levels of LDL-C and TC were decreased significantly in the very elderly group and the conventional treatment group at the 12th week when compared with the baseline levels(P<0.05,P<0.01),and the LDL-C level at the week was notably lower in the very elderly group than the conventional treatment group(1.36±0.44 mmol/L vs 1.87±0.56 mmol/L,P<0.01).But no difference was seen in the incidence of MACE between the 2 groups(12.2%vs 16.0%,P>0.05),either in survival rate between them(P=0.576).Conclusion For patients of all ages,evolocumab has good short-term efficacy in lipid control,and for those over 75 years old,the drug also shows good efficacy and sound safety.