西立伐他汀治疗高胆固醇血症的疗效

Efficacy and safety of cerivastatin in treatment of primary hypercholesterolaemia

目的 :探讨西立伐他汀治疗原发性高胆固醇血症的有效性及安全性。方法 :分为 3个阶段 ,第一阶段(A阶段 )为 5周的单盲进入阶段 ,第二阶段 (B阶段 )为期 8周 ,将 470例患者随机分为 0 .1mg组 ( 119例 )、0 .2mg组 ( 117例 )、0 .3mg( 116例 )和安慰剂组 ( 118例 ) ,均为 qd ,睡前服用。B阶段结束时 ,LDL C水平较试验前降低≥2 0 %者 ,继续B阶段治疗 (西立伐他汀或安慰剂 ) 16周 (C阶段 ) ,以延长安全性的评价时间。结果 :西立伐他汀各组的LDL C降低百分数分别为 ( 2 1.5± 31.1) % ( 0 .1mg组 ) ,( 2 5 .8± 13.0 ) % ( 0 .2mg组 )和 ( 2 9.5± 2 0 .5 ) % ( 0 .3mg组 ) ,安慰剂组的LDL C较试验前升高 ( 0 .7± 13 .0 ) % ,与各用药组相比 ,P值均为 0 .0 0 0 1。结论

Objective:To study the efficacy of cerivastatin in treatment of hypercholesterolaemia. Methods:After a 5 weeks singleblind runin period (Period A),470 patients were randomised to receive cerivastatin 0.1 mg(n=119),0.2 mg (n=117),0.3 mg(n=116) or placebo(n=118),once daily at bedtime for 8 weeks(Period B).At the end of Period B,patients with a lowdensity lipoprotein cholesterol decrease of ≥20% from baseline continued to receive their randomised dose of cerivastatin or placebo for a further 16 weeks,for an extended assessment of safety.Results:Mean percentage change in lowdensity lipoprotein cholesterol from baseline to the end of Period B in the perprotocol population (the primary efficacy parameter)was -(21.5±13.1)% in the 0.1 mg group,-(25.8±13.0)% in the 0.2 mg group and -(29.5±20.5)% in the 0.3 mg group,compared with a (0.7±13.0)% increase in the placebo group(P=0.0001 for all doses versus placcbo).Conclusion:Cerivastatin was found to have a good efficacy and safety profile in the Chinese hypercholesterolaemic population studied.