| Background: Coronary heart disease has become the number one killer of chronic health, and acute coronary syndrome is the fatal cause of death and disability. Atherosclerosis is an important pathological mechanism in its pathogenesis, and dyslipidemia is also a important risk factor for atherosclerosis. Therefore, lipid-lowering therapy has become an important part of the treatment of patients with acute coronary syndrome.According to the "China adult dyslipidemia Prevention Guide" in 2007 and the European Society of Cardiology / European Atherosclerosis Society(ESC / EAS) guide in 2011,they all defined the ACS patients as a very high risk populations, so they need early intensive lipid-lowering therapy;According to the 2011 ESC / EAS guidelines, the LDL-C need to decreased to <1.8mmol / L, or LDL-C decreased by more than 50% of baseline. Thus,early intensive lipid-lowering therapy meaning is clear for ACS patients.Guidelines think that intensive lipid-lowering therapy included inatorvastatin 80 mg and rosuvastatin 20-40 mg can be used for the very high-risk population, but there is still some patients with LDL-C can not reach the standard.Because of the restriction of "the principle of statin 6",as statin dose increased, the liver, muscle and other drug side effects increases. So guidelines recommend that for statin intolerance or even high-dose statin LDL-C is still not compliance patients can combine statin with other lipid-lowering drugs, and cholesterol absorption inhibitors(ezetimibe) has more researches. There have been a number of large studies that have confirmed whether high-dose stain or conventional statin combine with ezetimibe were significantly benefit from the lowering and cardiovascular events abroad, but whether the high-dose stain or conventional statin combine with ezetimibe is good for the Chinese people in intensive lipid-lowering therapy. the conclusions differ, and there is a lack of sufficient evidence.Objective: The present study was designed to compare the effectiveness and safety of ezetimibe and rosuvastatin versus high-dose rosuvastatin in patients with acute coronary syndrome,and provide evidence for the clinical treatment of acute coronary syndrome.Methods: 125 cases of patients diagnosed with acute coronary syndrome were randomly divided into conventional treatment group(Rosuvastatin 10mg/d), high-dose rosuvastatin group(Rosuvastatin20mg/d) and combination lipid-lowering group(Ezetimibe 10mg/d andRosuvastatin 10mg/d).All patients had a 12-weeks follow-up with the effectivity markers(TG、TC、HDL-C、LDL-C,etal.)、 safety markers(liver function, renal function, CK, CK-MB) and other index,aslo we collection all the occurrence of cardiovascular events and drug adverse events during the study.Result:1)basic line:There is 125 subjects whose mean age is 60.5±8.4 years,and 93 male(74.4%) cases included.There is no difference between three groups in lipid levels, liver and kidney function, myocardial enzymes,hs-CRP at baseline, also,they have a similar smoking history,hypertension history, cerebral infarction history,diabetes history and other cardiovascular disease risk factors or the usage in combined drugs;2)lipid levels and decline: All the three kinds of lipid-lowering therapy can significantly reduce TG, LDL-C levels compared with baseline.After 4weeks of lipid-lowering therapy, the TC levels in combination lipid-lowering group is significantly lowwer than the conventional therapy group and the high-dose rosuvastatin group [(1.796±0.409) vs(4.306±0.792)vs(3.869±0.565) mmol / L,(P<0.05)], also accompanied with a significant drop in TC decline[(50.29 ± 8.69%)vs(29.03% ± 10.06%) vs(37.90% ±13.71%),(P <0.05)]; After 12 weeks of lipid-lowering therapy, the TC levels in combination lipid-lowering group is significantly lowwer than the conventional therapy group and the high-dose rosuvastatin group [(1.186 ±0.437)vs(3.860±0.630) vs(1.660±0.377) mmol/L,(P<0.05)], accompanied with a significant drop in TC decline[(46.41% ± 10.62%) vs(26.14 % ±10.47%) vs(36.54% ± 12.55%),P <0.05)].After 4 weeks of lipid-lowering therapy, the LDL-C levels in combination lipid-lowering group is significantly lowwer than the conventional therapy group and the high-dose rosuvastatin group [(3.447 ± 0.755)vs(2.542 ± 0.554) vs(2.203 ± 0.537)mmol/L,(P<0.05)], also accompanied with a significant drop in LDL-C decline[(46.41%±10.62%)vs(18.21%±8.32%) vs(25.96%±12.37%),(P<0.05)]; After 12 weeks of lipid-lowering therapy, the LDL-C levels in combination lipid-lowering group is significantly lowwer than the conventional therapy group and the high-dose rosuvastatin group [(2.861±0.711)vs(2.002±0.449) vs(3.287±0.389) mmol/L,(P<0.05)], accompanied with a significant drop in LDL-C decline[(67.28%±10.69%) vs(43.89% ±10.52%) vs(52.80% ± 11.91%), P <0.05)]; All the three groups had significantly decreased the TG levels compared with baseline, but there was no significant difference among the three groups;There was no significant difference in and among three groups in HDL-C.3) lipid compliance rate: according to the European Society of Cardiology / European Atherosclerosis Society(ESC/EAS) in 2011, we set the LDL-C<1.81mmol/L as the lipid compliance standard line.After a4-weeks follow-up,the compliance rates in combination lipid-lowering group is significantly more than the conventional therapy group and thehigh-dose rosuvastatin group(50.0%vs7.1% vs17.1%,P <0.05), respectively,at 12 weeks, the compliance rates in combination lipid-lowering group is significantly more than the conventional therapy group and the high-dose rosuvastatin group(81.0%vs33.3% vs68.3%,P <0.05);we set the LDL-C decreased by more than 50% as the lipid compliance standard line.we collection a significantly distinguish compliance rate between the conventional therapy group, the high-dose rosuvastatin group and the combination lipid-lowering group(2.4% vs22.0% vs52.4%,P <0.05)aftert 4weeks, also aftert 12 weeks(33.3% vs68.3% vs90.5%,P <0.05);4) safety-related indicators: With a 12-week follow-up, there were no significant difference in ALT, AST, AKP, GGT, TBIL, DBIL,IBIL,CR,BUNamong the three groups, but all the three groups in ALT,AST,TBIL, DBIL, IBIL levels had elevated compared to the baseline.The CK, CK-MB level in the high-dose rosuvastatin group is significantly more than the conventional therapy group and the combination lipid-lowering group after 4 weeks,respectively [(97.38 ±30.046) vs(94.845±23.915) vs(68.090±17.413) IU/L,(P <0.05)], [(11.489±3.422) vs(11.042±2.558) vs(9.250±2.847) IU/L,(P <0.05)]; also after 12 weeks in CK, CK-MB levels, respectively [(129.837±47.523) vs(83.776 ±31.543) vs67.164±18.177) IU/L,(P <0.05)],[(14.248±2.447) vs(11.820±4.665) vs( 8.612±2.022) IU/L,(P <0.05)];5) Other indicators: After 12 weeks of lipid-lowering therapy, all thethree kinds of lipid-lowering therapy were able to reduce hs-CRP, and the hs-CRP levels at 12 weeks in the conventional therapy group is significantly more than the high-dose rosuvastatin group and the combination lipid-lowering group [(0.503 ± 0.164) vs(0.513 ± 0.189) vs(1.004 ± 1.154) mg / L,(P <0.05)],but there was no difference between the combination lipid-lowering group and he high-dose rosuvastatin group; all the three kinds of lipid-lowering therapy were able to reduce UA levels,but there is no difference among the three groups.6)cardiovascular events: With a 12-week follow-up, the cardiovascular events in combination lipid-lowering group is lower than the conventional therapy group and the high-dose rosuvastatin group[2/42(4.8%)vs5/42(11.9%)vs4/41(9.8%),P>0.05];7) drug-related adverse reactions: With a 12-week follow-up, the drug-related adverse events in combination lipid-lowering group is lower than the conventional therapy group and the high-dose rosuvastatin group[2/42(4.8%)vs1/42(2.4%)vs7/41(17.1%),P<0.05];Conclusion:1) All the kinds of lipid solutions can significantly reduce TG, LDL-C levels, and the ezetimibe 10 mg plus rosuvastatin calcium 10 mg group is better than the rosuvastatin calcium 20 mg group and the rosuvastatin calcium 10 mg group in the decline of lipid and the compliance rate, but there is no significant difference among the three groups in the rate of theincidence of cardiovascular events.2) Rosuvastatin calcium 20 mg is more elevated than the ezetimibe10 mg plus rosuvastatin calcium 10 mg group and the rosuvastatin calcium10 mg in CK and CK-MB levels, as well as the change in the incidence of adverse drug events. |
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