Patel J V, Hughes E A
Sandwell Medical Research Unit, Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK.
Int J Clin Pract. 2006 Aug;60(8):914-21. doi: 10.1111/j.1742-1241.2006.01023.x.
It is increasingly accepted that more intensive lipid-lowering treatment is associated with greater cardiovascular risk reductions in patients with coronary heart disease (CHD), thus providing a rationale for more aggressive LDL-cholesterol (LDL-C) targets. Ezetimibe in combination with statin therapy provides an additional approach to lipid management by utilising the additive action of two different mechanisms of LDL-C reduction. In this multicentre, randomised, double-blind, placebo-controlled study, a total of 98 men and 55 women with CHD and primary hypercholesterolaemia, naïve to statin therapy, were randomised to receive treatment for 6 weeks with either ezetimibe 10 mg-simvastatin 20 mg (n = 77) or placebo-simvastatin 20 mg (n = 75). At 6 weeks, ezetimibe 10 mg-simvastatin 20 mg provided a mean additional LDL-C reduction of 14.6% (95% CI 10.1-19.1) compared with simvastatin monotherapy (p < 0.0001). Moreover, a higher proportion of patients on ezetimibe/simvastatin achieved the National Standard Framework LDL-C standard (<3.0 mmol/l; 93% vs. 75%, p < 0.001) or the new Joint British Societies (JBS 2) goal of LDL-C < 2.0 mmol/l (49.3% vs. 11.1%, p < 0.001). On logistic regression analysis, the odds ratio of achieving target LDL-C with ezetimibe 10 mg-simvastatin 20 mg was 5.1 (95% CI 1.8-15.0) times higher than with simvastatin monotherapy (p = 0.003). Clinical chemistry profiles and proportions of adverse events were similar in both groups at baseline and follow-up. In conclusion, ezetimibe 10 mg-simvastatin 20 mg is a practical, effective and safe option for the treatment of primary hypercholesterolaemia in CHD patients, and brings more patients to new aggressive cholesterol targets compared with simvastatin 20 mg monotherapy.
越来越多的人认为，强化降脂治疗与冠心病（CHD）患者心血管风险的更大降低相关，从而为更积极的低密度脂蛋白胆固醇（LDL-C）目标提供了理论依据。依折麦布与他汀类药物联合治疗通过利用两种不同的降低LDL-C机制的相加作用，为血脂管理提供了另一种方法。在这项多中心、随机、双盲、安慰剂对照研究中，共有98名男性和55名患有CHD和原发性高胆固醇血症且未接受过他汀类药物治疗的女性，被随机分配接受6周的治疗，其中一组接受依折麦布10 mg-辛伐他汀20 mg（n = 77），另一组接受安慰剂-辛伐他汀20 mg（n = 75）。在6周时，与辛伐他汀单药治疗相比，依折麦布10 mg-辛伐他汀20 mg使LDL-C平均额外降低了14.6%（95% CI 10.1 - 19.1）（p < 0.0001）。此外，接受依折麦布/辛伐他汀治疗的患者中，达到国家标准框架LDL-C标准（<3.0 mmol/l；93%对75%，p < 0.001）或新的英国联合学会（JBS 2）LDL-C目标<2.0 mmol/l（49.3%对11.1%，p < 0.001）的比例更高。在逻辑回归分析中，使用依折麦布10 mg-辛伐他汀20 mg达到目标LDL-C的优势比是辛伐他汀单药治疗的5.1倍（95% CI 1.8 - 15.0）（p = 0.003）。两组在基线和随访时的临床化学指标及不良事件比例相似。总之，依折麦布10 mg-辛伐他汀20 mg是治疗CHD患者原发性高胆固醇血症的一种实用、有效且安全的选择，与辛伐他汀20 mg单药治疗相比，能使更多患者达到新的积极胆固醇目标。
