Combination therapy analysis of ezetimibe and statins in Chinese patients with acute coronary syndrome and type 2 diabetes

Lipids in Health and Disease

Daqing Zhang²  Jie Shen²  Yali Shen²  Yang Li²  Fuxiang Su²  Minli Zhang²  Lulu Li¹ 

[1] Charite University of Berlin, Berlin, Germany;Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China

关键词: Combination therapy;    Ezetimibe;    Statins;    Diabetes;    Acute coronary syndrome;   

Others  :  1132946
DOI  :  10.1186/s12944-015-0004-7

 received in 2014-08-25, accepted in 2015-01-27,  发布年份 2015

【 摘 要 】

Background

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.

Methods

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 7^th and 30^th after treatment.

Results

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 7^th, 1.51 ± 0.29 and 1.94 ± 0.49 mmol/L at day 30^th, 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.

Conclusion

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.

【 授权许可】

   
2015 Li et al.; licensee BioMed Central.

【 图 表 】

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【 参考文献 】

• [1]Goldfine Allison B, Beckman Joshua A: Life and death in Denmark: lessons about diabetes and coronary heart disease. Circulation 2008, 117:1914-1917.
• [2]Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M: Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 1998, 339:229-234.
• [3]Delahoy PJ, Magliano DJ, Webb K, Grobler M, Liew D: The relationship between reduction in low-density lipoprotein cholesterol by statins and reduction in risk of cardiovascular outcomes: an updated meta-analysis. Clin Ther 2009, 31:236-244.
• [4]Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, et al.: 2014 AHA/ACC Guideline for the Management of patients with non-ST-elevation acute coronary syndrome. J Am Coll Cardiol 2014, S0735-1097(14):06279-2.
• [5]Zhao S, Wang Y, Yiming M, Yu B, Ye P, Yan X, et al.: Prevalence of dyslipidaemia in patients treated with lipid-lowering agents in China: Results of the DYSlipidemia International Study (DYSIS). Atherosclerosis 2014, 235:463-9.
• [6]Rocco Michael BR: Statins and diabetes risk: fact, fiction, and clinical implications. Cleve Clin J Med 2012, 79:883-893.
• [7]HPS2-THRIVE Collaborative Group: HPS2-THRIVER randomized placebo-controlled trial in 25673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment Eur Heart J 2013, 34:1279-91.
• [8]Neal Ryan C, Jones Peter H: Complementary therapy to target LDL cholesterol: the role of the ezetimibe/simvastatin combination. Vasc Health Risk Manage 2006, 2:31-8.
• [9]Mikhailidis DP, Sibbring GC, Ballantyne CM, Davies GM, Catapano AL: Meta-analysis of the cholesterol-lowering effect of ezetimibe added to ongoing statin therapy. Curr Med Res Opin 2007, 23:2009-26.
• [10]Necati D, Mustafa Y, Ilgin K: The effects of high dose pravastatin and low dose pravastatin and ezetimibe combination therapy on lipid, glucose metabolism and inflammation. Inflammation 2007, 30:230-5.
• [11]Nomura M, Ishii H, Kawakami A, Kajinami A, Yoshida M: Inhibition of hepatic Neiman-pick C1-Like 1 improves hepatic insulin resistance. Am J Physiol Endocrinol Metab 2009, 297:E1030-8.
• [12]Joint committee for developing Chinese guidelines on Prevention and Treatment of Dyslipidemia in Adults: Chinese guidelines on prevention and treatment of dyslipidemia in adults Zhonghua Xin Xue Guan Bing Za Zhi 2007, 35:390-419.
• [13]He J, Gu D, Wu X, Reynolds K, Duan X, Yao C, et al.: Major causes of death among men and women in China. N Engl J Med 2005, 353:1124-34.
• [14]Pedersen TR, Faergeman O, Kastelein JJ, Olsson AG, Tikkanen MJ, Holme I, et al.: Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005, 294:2437-45.
• [15]Cannon CP, Braunwald E, McCabe CH, Grayston JT, Muhlestein B, Giugliano RP, et al.: Pravastatin or Atorvastatin evaluation and infection therapy-thrombolysis in myocardial infarction 22 investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004, 350:1495-504.
• [16]Deharo P, Pankert M, Quilici J, Grosdidier C, Verdier V, Bonnet G, et al.: Safety and effectiveness of the association ezetimibe-statin (E-S) versus highdose rosuvastatin after acute coronary syndrome: the safe-ES study. Ann Cardiol Angeiol 2014, 63:222-7.
• [17]Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, et al.: Myocardial ischemia reduction with aggressive cholesterol lowering (MIRACL) study investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001, 285:1711-8.
• [18]Chenot F, Montant PF, Marcovitch O, Blaimont M, de Meester A, Descamps OS: Co-administration of ezetimibe and simvastatin in acute myocardial infarction. Eur J Clin Invest 2007, 37:357-63.
• [19]Ballantyne CM, Houri J, Notarbartolo A, Melani L, Lipka LJ, Suresh R, et al.: Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Ciculation 2003, 107:2409-15.
• [20]Moutzouri E, Liberopoulos EN, Tellis CC, Milionis HJ, Tselepis AD, Elisaf MS: Comparison of the effect of simvastatin versus simvastatin/ezetimibe versus rosuvastatin on markers of inflammation and oxidative stress in subjects with hypercholesterolemia. Atherosclerosis 2013, 231:8-14.
• [21]Undas A, Machnik A, Potaczek DP, Wypasek E, Zmudka K, Tracz W: Ezetimibe combined with simvastatin compared with simvastatin alone results in a greater suppression of oxidative stress and enhanced fibrinolysis in patients after acute coronary events. J Cardiovasc Pharma 2011, 58:167-72.
• [22]Takase H, Dohi Y, Okado T, Hashimoto T, Goto Y, Kimura G: Effects of ezetimibe on visceral fat in the metabolic syndrome: a randomized controlled study. Eur J Clin Invest 2012, 42:1287-94.