Li Lulu, Zhang Minli, Su Fuxiang, Li Yang, Shen Yali, Shen Jie, Zhang Daqing
Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China.
Charite University of Berlin, Berlin, Germany.
Lipids Health Dis. 2015 Feb 18;14:10. doi: 10.1186/s12944-015-0004-7.
Dyslipidemia management situation in Chinese patients with high risk and very high risk has been demonstrated very low, despite the wide use of statins. The effects and safety of the combined treatment of ezetimibe (EZ) and statins in Chinese patients with acute coronary syndrome (ACS) and type 2 diabetes mellitus (T2DM) remain unknown.
Chinese Patients with ACS and T2DM were divided into the statins group (n=40) and the combination group of EZ and statins (n=44). In order to evaluate the clinical effects on lipids-lowering, systemic inflammation response and clinical safety, the follow-up of all patients was carried out at day 7th and 30th after treatment.
The level of low-density lipoprotein cholesterol (LDL-C) in combination group and statins group was 1.87±0.42 and 2.18±0.58 mmol/L at day 7th, 1.51±0.29 and 1.94±0.49 mmol/L at day 30th, respectively. The control rates of LDL-C level in the combination group and the statins group were 77% and 45% at day 30(th), respectively. There was no significant improvement on high-density lipoprotein cholesterol (HDL-C) level during follow-up. The triglyceride (TG) levels were significantly reduced in both groups, while no obvious difference was observed between two groups. No significant difference on serum high-sensitivity C-reactive protein (hs-CRP) level between two groups was observed. Moreover, we did not observe any significant correlation between serum lipids levels and serum hs-CRP level during follow-up. The liver dysfunction and muscle related side effects (MRSE), creatine kinase (CK) and myopathy were not observed in both groups.
Our study demonstrated that it is feasible to initiate combination therapy during acute phase for Chinese patients with ACS and T2DM, which can bring more significant effect on LDL-C-lowering and improve the control rate of LDL-C level with good safety.
尽管他汀类药物广泛应用,但中国高危和极高危患者的血脂异常管理情况仍显示非常低。依折麦布(EZ)与他汀类药物联合治疗对中国急性冠状动脉综合征(ACS)和2型糖尿病(T2DM)患者的疗效和安全性尚不清楚。
将中国ACS和T2DM患者分为他汀类药物组(n = 40)和EZ与他汀类药物联合组(n = 44)。为了评估降脂、全身炎症反应和临床安全性的临床效果,在治疗后第7天和第30天对所有患者进行随访。
联合组和他汀类药物组在第7天时低密度脂蛋白胆固醇(LDL-C)水平分别为1.87±0.42和2.18±0.58 mmol/L,在第30天时分别为1.51±0.29和1.94±0.49 mmol/L。联合组和他汀类药物组在第30天时LDL-C水平的控制率分别为77%和45%。随访期间高密度脂蛋白胆固醇(HDL-C)水平无显著改善。两组甘油三酯(TG)水平均显著降低,但两组间无明显差异。两组血清高敏C反应蛋白(hs-CRP)水平无显著差异。此外,随访期间未观察到血脂水平与血清hs-CRP水平之间存在任何显著相关性。两组均未观察到肝功能障碍和肌肉相关副作用(MRSE)、肌酸激酶(CK)和肌病。
我们的研究表明,对中国ACS和T2DM患者在急性期开始联合治疗是可行的,这可以对降低LDL-C带来更显著的效果,并提高LDL-C水平的控制率,且安全性良好。