背景:他汀类药物使用者的亚群,例如患有慢性肾病(CKD)的受试者,人类免疫病毒(HIV),急性冠状动脉综合征(ACS),血运重建,代谢综合征,和/或糖尿病可能特别受益于匹伐他汀药物治疗。
目的:本系统综述旨在系统评价匹伐他汀对接受匹伐他汀治疗的受试者与其他四种他汀类药物相比对原发性心脏事件的影响。
方法:我们对随机对照试验的III期和IV期(RCT-s,11项试验)适用于接受匹伐他汀治疗的原发性心脏事件受试者。受试者诊断为任何类型的血脂异常(人口4804),并接受匹伐他汀(干预)与比较(比较),主要疗效终点为LDL-C和非HDL-C的最小化,HDL-C升高和/或主要不良心脏事件减少(MACE,心血管死亡,心肌梗死(致命/非致命),和卒中(致命/非致命)和/或其复合(结局)。次要安全终点是任何不良反应的发展。
结果:在纳入的试验中(11),参与者(4804)被随机分配匹伐他汀或其比较剂,如阿托伐他汀,普伐他汀,瑞舒伐他汀,并随访12~52周。就主要结果(LDL-C降低)而言,在三项试验中,匹伐他汀4mg优于普伐他汀40mg,而2mg匹伐他汀在4项试验中与10mg阿托伐他汀相当,在2项试验中与20mg和40mg辛伐他汀相当。然而,在两项试验中,瑞舒伐他汀2.5mg优于匹伐他汀2mg。在11项试验中,匹伐他汀增加HDL-C,降低非HDL-C。关于安全性,匹伐他汀已被证明是耐受和安全的。
结论:FDA批准的匹伐他汀的适应症包括原发性血脂异常和混合血脂异常,作为饮食改变以降低总胆固醇的补充疗法,LDL-C,载脂蛋白B(载脂蛋白B),甘油三酯(TG),增强HDL-C匹伐他汀可能适合糖尿病患者,ACS(减少血运重建),代谢综合征,CKD,艾滋病毒,和HDL-C水平低的受试者我们强烈建议合理的个体化选择他汀类药物。
A subpopulation of statin users such as subjects with chronic kidney disease (CKD), Human Immune virus (HIV), acute coronary syndrome (ACS), revascularization, metabolic syndrome, and/or diabetes may particularly benefit from pitavastatin pharmacotherapy.
The current systematic
review aimed systematically to evaluate the effect of
pitavastatin on primary cardiac events in subjects receiving pitavastatin in comparison to the other four statin members.
We conducted a systematic
review on phases III and IV of randomized controlled trials (RCT-s, 11 trials) for subjects with primary cardiac events who received
pitavastatin. Subjects diagnosed with any type of dyslipidemia (population 4804) and received pitavastatin (interventions) versus comparator (comparison) with the primary efficacy endpoint of minimization of LDL-C and non- HDL-C, had an increase in HDL-C and/or reduction in major adverse cardiac events (MACE, cardiovascular death, myocardial infarction (fatal/nonfatal), and stroke (fatal/nonfatal) and/or their composite (outcomes). The secondary safety endpoint was the development of any adverse effects.
In the included trials (11), participants (4804) were randomized for pitavastatin or its comparators such as atorvastatin, pravastatin, rosuvastatin, simvastatin and followed up for 12 to 52 weeks. In terms of the primary outcome (reduction in LDL-C), pitavastatin 4 mg was superior to pravastatin 40 mg in three trials, while the 2 mg pitavastatin was comparable to atorvastatin 10 mg in four trials and simvastatin 20 and 40 mg in two 2 trials. However, rosuvastatin 2.5 mg was superior to
pitavastatin 2 mg in two trials.
Pitavastatin increased HDL-C and reduced non-HDL-C in eleven trials. Regarding the safety profile, pitavastatin has proved to be tolerated and safe.
The FDA-approved indications for pitavastatin included primary dyslipidemia and mixed dyslipidemia as a supplementary therapy to dietary changes to lower total cholesterol, LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and enhance HDL-C. Pitavastatin might be suitable for subjects with diabetes, ACS (reduced revascularization), metabolic syndrome, CKD, HIV, and subjects with low levels of HDL-C. We highly recommend rational individualization for the selection of statin.