Study On Efficacy And Safety Of Intensive Lipid Lowering In Acute Coronary Syndrome

ObjectivesAcute coronary syndrome is emergent in coronary heart disease with high morbidity and mortality. Over the last decade, large magnitude of evidence from large-scale clinical trials have tested the efficacy of using intensive dose of statin at the early stage of acute coronary syndrome which would reduce incidence of cardiovascular events and increase survival rate.The guidelines for management of dyslipidaemias in Amenrica and Europe have recommended intensification of statin therapy for acute coronary syndrome (ACS) to achieve low-density lipoprotein cholesterol (LDL-C) goals.2007"China adult dyslipidemia prevention guide" also recommended controlling blood lipid concentration at low level for ACS patients.But lipid goal attainment in very high risk patients reported from western clinical investigations is low. Lipid level of Chinese is lower than westerner and little information could be aquired about the LDL-C achievement and safety of intensifying lipid-lowering therapy in Chinese ACS.This study was designed to evaluate the efficacy and safety of initiation of intensive dose of statins for Chinese ACS patients.MethodsPatients were followed up for a mean of two years.1355ACS patients were assigned to intensive statin therapy group(atorvastatin,20or40mg/d, or equivalent dose of other statins, n=680) or standard statin therapy group (atorvastatin,10mg/d, or equivalent dose of other statins, n=675) ramdomly. Patients were followed up at the centers at1.5,3,12,24months and fasting blood samples for lipid (TC, LDL-C, HDL-C, TG) were collected at each point. We assess the percentage of ACS patients attaining LDL-C goal and identify the possible factors independently associated with failure to attain LDL-C goal. Liver enzymes,CK were tested and other safety parameters such as incidence of hemorrhagic stroke were also noted for safety assessment.ResultsAll the patents have a mean age of60.63±10.61years, males take majority of the study population (76.90%). Baseline characteristics including lipid level, blood pressure, medical history,other cardiovascular risk factors were well balanced between the2treatment groups and could be well matched. At1.5months, There were no significant differences in lipid level between the two groups. At3months,patients in20mg group had the lower mean LDL-C concentration compared with those in10mg group(1.99±0.74mmol/l VS2.17±0.75mmol/l). Compared to their initial level,the reduction of LDL-C concentration in two treatment group were20%and13%respectively(P<0.001).According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines,the goal attainment of LDL-C<1.8mmol/1was45.35%in intensive group and33.82%in standard group with a significant difference. According to2007"China adult dyslipidemia prevention guide"target level of LDL-C<2.01mmol/l,61.18%in intensive group and47.9%in standard meet the goal with a significant difference.Those people who have a age<60years,LDL-C baseline level reached the goal, intensive statin therapy are prond to meet LDL-C goal. The rate of elevations in hepatic transaminases to>3times the upper limit of normal (ULN) in intensive group and standard group was1.91%and1.48%respectively,the rate of elevation in creatine phosphokinase (CK)(>5x ULN) in intensive group and standard group was0.29%and0.15%,but without significant differences.There are two case of hemorrhagic stroke in standard group, no cases of hemorrhagic stroke reported in intensive group but without significant differences.ConclusionsChinese ACS patients have a low level of blood lipids.Intensive statin therapy(atorvastatin at20-40mg/d or equivalent dose of other statins) is more effective in lipid-modifying than standard statin therapy group (atorvastatin10mg/d or equivalent dose of other statins) and adverse events related with statin occurred infrequently and rarely. The success rate of LDL-C level in intensive group is higher which still should be improved. Factors of age<60years,LDL-C baseline level reached the goal, intensive statin therapy contributes to the higher LDL-C goal attainment.