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首页> 外文期刊>Drugs of today: Medicamentos de actualidad >PCSK9 INHIBITORS: MONOCLONAL ANTIBODIES FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA
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PCSK9 INHIBITORS: MONOCLONAL ANTIBODIES FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA

机译：PCSK9抑制剂：单克隆抗体治疗高胆固醇血症

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In 2015 the U.S. Food and Drug Administration approved the first two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, alirocumab (Praluent (R); Sanofi/Regeneron) and evolocumab (Repatha (R); Amgen), for use in patients with heterozygous and homozygous familial hypercholesterolemia and for patients intolerant of statins or those with a major risk of cardiovascular disease (CVD) but unable to lower their LDL cholesterol (LDL-C) to optimal levels with statins and ezetimibe. Numerous randomized clinical trials have demonstrated that these inhibitors cause a fall in LDL-C levels of 50-60% as well as causing a decline in lipoprotein(a) and an increase in HDL cholesterol. They are effective in reducing levels of LDL-C to 1.8 mmol/L or less in almost all patients in the groups listed above except for those with homozygous familial hypercholesterolemia. In the latter case, many patients will still have LDL-C levels well above optimal levels despite the use of statins and a PCSK9 inhibitor. To date these inhibitors have not caused major adverse effects. However, the results of ongoing long-term randomized clinical trials are needed to determine whether they cause a significant reduction in CVD events including deaths from CVD. These studies will also demonstrate whether the PCSK9 inhibitors have any unexpected adverse effects and/or effects resulting from the loss of PCSK9 functions at other sites in the body, in particular regarding neurocognition. A further major concern is the high cost of PCSK9 inhibitors and their effect on healthcare costs and health insurance premiums.
机译：2015年，美国食品药品监督管理局批准了前两种前蛋白转化酶枯草杆菌蛋白酶/ kexin 9型（PCSK9）抑制剂alirocumab（Praluent（R）; Sanofi / Regeneron）和evolocumab（Repatha（R）; Amgen）用于患者具有杂合子和纯合子家族性高胆固醇血症的患者，对于不能接受他汀类药物或患有心血管疾病（CVD）但不能将他的LDL胆固醇（LDL-C）降低至他汀类药物和依折麦布的最佳水平的患者。许多随机临床试验表明，这些抑制剂可导致LDL-C水平下降50-60％，并导致脂蛋白（a）下降和HDL胆固醇增加。除纯合子家族性高胆固醇血症者外，上述组中的几乎所有患者均能有效地将LDL-C水平降低至1.8 mmol / L或更低。在后一种情况下，尽管使用他汀类药物和PCSK9抑制剂，许多患者的LDL-C水平仍将远高于最佳水平。迄今为止，这些抑制剂尚未引起严重的不良影响。但是，需要进行中的长期随机临床试验的结果来确定它们是否引起CVD事件（包括CVD死亡）的显着减少。这些研究还将证明PCSK9抑制剂是否具有任何意想不到的不利影响和/或由于PCSK9在体内其他部位的功能丧失而引起的影响，特别是在神经认知方面。另一个主要问题是PCSK9抑制剂的高成本及其对医疗保健费用和健康保险费的影响。

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