目的评价Evolocumab降低低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)的有效性及安全性。方法通过电子数据库检索所有评价Evolocumab治疗高LDL-C的随机对照研究,采用RevMan5.2软件对数据进行Meta分析。结果一共纳入...目的评价Evolocumab降低低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)的有效性及安全性。方法通过电子数据库检索所有评价Evolocumab治疗高LDL-C的随机对照研究,采用RevMan5.2软件对数据进行Meta分析。结果一共纳入5项前瞻性随机对照研究,包括1 396个病例。Meta分析结果显示:与安慰剂比较,Evolocumab可显著降低LDL-C(WMD=-55.04,95%CI=-57.45^-52.62,P<0.05)。两组在治疗后转氨酶升高大于3倍正常值上限(OR=0.57,95%CI=0.20~1.61)、肌酸激酶升高大于5倍正常值上限(OR=2.52,95%CI=0.63~10.00)、严重不良事件(OR=1.49,95%CI=0.82~2.73)、因药物不良事件导致停药(OR=1.17,95%CI=0.51~2.72)发生等方面差异均无统计学意义(P>0.05)。结论现有临床试验数据表明,Evolocumab降低LDL-C是安全有效的。展开更多
1文献来源研究一：Sabatine MS,Giugliano RP,Wiviott SD,et al.Efficacy and safety of Evolocumab inreducing lipids and cardiovascular events[J].N EnglJ Med,2015,372（16）：1500-1509.研究二：Robinson JG,Farnier M,Krempf M,
Aims: There has been no evidence on the effects of evolocumab, protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, on small size LDL. We observationally investigated the efficacy and side effects of evolocum...Aims: There has been no evidence on the effects of evolocumab, protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, on small size LDL. We observationally investigated the efficacy and side effects of evolocumab on the LDL subfraction particle diameter using PAGE system for lipoprotein analysis. Methods: We defined 30 patients with high-risk hyperlipidemia. As for analysis of LDL subfraction profile, we used polyacrylamide gel electrophoresis three methods: 1) 3% nondenatured poly-acrylamide gel electrophoresis method (3%PAGE), 2) 2% - 16% nondenatured poly-acrylamide gradient gel electro-phoresis method (2% - 16% GGE) and 3) 2.7% - 5% GGE. Evolocumab 140 mg/day administered together with statin significantly improved serum total cholesterol (TC), triglyceride (TG), high-dense lipoprotein-cholesterol (HDL-C), and LDL-C after four-week treatment. Results: TC, TG, HDL-C and LDL-C levels were improved by, respectively, 33%, 20%, 10%, and 54%. The mean LDL size significantly increased from 25.6 ± 0.4 nm to 26.4 ± 0.8 nm. The small dense LDL-cholesterol (sdLDL-C), large buoyant LDL-cholesterol (lbLDL-C), and mid-band lipoprotein-cholesterol were reduced, respectively. Therefore, the preliminary study on this paper can be the first step into a new insight on the world of lipid metabolism. Conclusion: Short-term administration of evolocumab addedons to statin therapy, significantly reduced small size LDL levels.展开更多
Background:Evolocumab,a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9,is widely used in adult patients to lower low-density lipoprotein(LDL)cholesterol levels.Its effec...Background:Evolocumab,a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9,is widely used in adult patients to lower low-density lipoprotein(LDL)cholesterol levels.Its effects in pediatric patients with heterozygous familial hypercholesterolemia are not known.Methods:We conducted a 24-week,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia.Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter(3.4 mmol per liter)or more and a triglyceride level of 400 mg per deciliter(4.5 mmol per liter)or less were randomly assigned in a 2:1 ratio to receive monthly subcutaneous injections of evolocumab(420 mg)or placebo.The primary end point was the percent change in LDL cholesterol level from baseline to week 24;key secondary end points were the mean percent change in LDL cholesterol level from baseline to weeks 22 and 24 and the absolute change in LDL cholesterol level from baseline to week 24.展开更多
Peripheral artery disease(PAD)is a common condition characterized by atherosclerosis in the peripheral arteries,associated with concomitant coronary and cerebrovascular diseases.Proprotein convertase subtilisin/kexin ...Peripheral artery disease(PAD)is a common condition characterized by atherosclerosis in the peripheral arteries,associated with concomitant coronary and cerebrovascular diseases.Proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors are a class of drugs that have shown potential in hypercholesterolemic patients.This review focuses on the efficacy,safety,and clinical outcomes of PCSK9 inhibitors in PAD based on the literature indexed by PubMed.Trials such as FOURIER and ODYSSEY demonstrate the efficacy of evolocumab and alirocumab in reducing cardiovascular events,offering a potential treatment option for PAD patients.Safety evaluations from trials show few adverse events,most of which are injection-site reactions,indicating the overall safety profile of PCSK9 inhibitors.Clinical outcomes show a reduction in cardiovascular events,ischemic strokes,and major adverse limb events.However,despite these positive findings,PCSK9 inhibitors are still underutilized in clinical practice,possibly due to a lack of awareness among care providers and cost concerns.Further research is needed to establish the long-term effects and cost-effectiveness of PCSK9 inhibitors in PAD patients.展开更多
文摘目的评价Evolocumab降低低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)的有效性及安全性。方法通过电子数据库检索所有评价Evolocumab治疗高LDL-C的随机对照研究,采用RevMan5.2软件对数据进行Meta分析。结果一共纳入5项前瞻性随机对照研究,包括1 396个病例。Meta分析结果显示:与安慰剂比较,Evolocumab可显著降低LDL-C(WMD=-55.04,95%CI=-57.45^-52.62,P<0.05)。两组在治疗后转氨酶升高大于3倍正常值上限(OR=0.57,95%CI=0.20~1.61)、肌酸激酶升高大于5倍正常值上限(OR=2.52,95%CI=0.63~10.00)、严重不良事件(OR=1.49,95%CI=0.82~2.73)、因药物不良事件导致停药(OR=1.17,95%CI=0.51~2.72)发生等方面差异均无统计学意义(P>0.05)。结论现有临床试验数据表明,Evolocumab降低LDL-C是安全有效的。
文摘1文献来源研究一：Sabatine MS,Giugliano RP,Wiviott SD,et al.Efficacy and safety of Evolocumab inreducing lipids and cardiovascular events[J].N EnglJ Med,2015,372（16）：1500-1509.研究二：Robinson JG,Farnier M,Krempf M,
文摘Aims: There has been no evidence on the effects of evolocumab, protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, on small size LDL. We observationally investigated the efficacy and side effects of evolocumab on the LDL subfraction particle diameter using PAGE system for lipoprotein analysis. Methods: We defined 30 patients with high-risk hyperlipidemia. As for analysis of LDL subfraction profile, we used polyacrylamide gel electrophoresis three methods: 1) 3% nondenatured poly-acrylamide gel electrophoresis method (3%PAGE), 2) 2% - 16% nondenatured poly-acrylamide gradient gel electro-phoresis method (2% - 16% GGE) and 3) 2.7% - 5% GGE. Evolocumab 140 mg/day administered together with statin significantly improved serum total cholesterol (TC), triglyceride (TG), high-dense lipoprotein-cholesterol (HDL-C), and LDL-C after four-week treatment. Results: TC, TG, HDL-C and LDL-C levels were improved by, respectively, 33%, 20%, 10%, and 54%. The mean LDL size significantly increased from 25.6 ± 0.4 nm to 26.4 ± 0.8 nm. The small dense LDL-cholesterol (sdLDL-C), large buoyant LDL-cholesterol (lbLDL-C), and mid-band lipoprotein-cholesterol were reduced, respectively. Therefore, the preliminary study on this paper can be the first step into a new insight on the world of lipid metabolism. Conclusion: Short-term administration of evolocumab addedons to statin therapy, significantly reduced small size LDL levels.
文摘Background:Evolocumab,a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9,is widely used in adult patients to lower low-density lipoprotein(LDL)cholesterol levels.Its effects in pediatric patients with heterozygous familial hypercholesterolemia are not known.Methods:We conducted a 24-week,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia.Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter(3.4 mmol per liter)or more and a triglyceride level of 400 mg per deciliter(4.5 mmol per liter)or less were randomly assigned in a 2:1 ratio to receive monthly subcutaneous injections of evolocumab(420 mg)or placebo.The primary end point was the percent change in LDL cholesterol level from baseline to week 24;key secondary end points were the mean percent change in LDL cholesterol level from baseline to weeks 22 and 24 and the absolute change in LDL cholesterol level from baseline to week 24.
文摘Peripheral artery disease(PAD)is a common condition characterized by atherosclerosis in the peripheral arteries,associated with concomitant coronary and cerebrovascular diseases.Proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors are a class of drugs that have shown potential in hypercholesterolemic patients.This review focuses on the efficacy,safety,and clinical outcomes of PCSK9 inhibitors in PAD based on the literature indexed by PubMed.Trials such as FOURIER and ODYSSEY demonstrate the efficacy of evolocumab and alirocumab in reducing cardiovascular events,offering a potential treatment option for PAD patients.Safety evaluations from trials show few adverse events,most of which are injection-site reactions,indicating the overall safety profile of PCSK9 inhibitors.Clinical outcomes show a reduction in cardiovascular events,ischemic strokes,and major adverse limb events.However,despite these positive findings,PCSK9 inhibitors are still underutilized in clinical practice,possibly due to a lack of awareness among care providers and cost concerns.Further research is needed to establish the long-term effects and cost-effectiveness of PCSK9 inhibitors in PAD patients.
