China Coronary Secondary Prevention Study (CCSPS) - Lipid-regulating
therapy with Xuezhikang for Secondary Prevention of Coronary Heart Disease China Coronary Secondary Prevention Study Group [Abstract] Objective To determine whether lipid-regulating therapy with Xuezhikang reduces the risk of coronary events and offers an impact on all-cause mortality in Chinese patients with coronary heart disease (CHD) with relatively low cholesterol levels compared with that of western population. Methods This study was a multicentre, randomized, double-blind, placebo-controlled, long term follow-up clinical trial designed to compare the effect of Xuezhikang capsule and placebo and conducted at 65 centers in 19 provinces in China. A total of 4870 CHD patients aged 18 to 75 years with definite myocardial infarction history who had baseline cholesterol levels between 4.40 and 6.47mmol/L(170-250mg/dl) were recruited between May 1996 and December 2003. Patients were randomly assigned to receive treatment with Xuezhikang capsule, 0.6g Bid or matching placebo and follow-up period was mean 4 years. The primary endpoint were coronary events, including nonfatal myocardial infarction and CHD death. The secondary endpoint, analysed
by the time of first events, was total mortality. Other events, also analysed by the time of first events, includ tumour, stroke, and the need for intervention procedure of percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG). Results During 4-years follow-up period, Xuezhikang significantly reduced the risk of the primary endpoint by 45.1% (P<0.0001)
compared with placebo group(5.72% vs 10.41%) because the relative risk reduction of CHD death and nonfatal myocardial infarction was 31.0% (P=0.0048) (3.79% vs 5.49%) and 60.8% (P<0.0001)( 1.93% vs.4.92%) respectively in patients who received Xuezhikang compared with those who received placebo. Of the secondary
end-point, There was a 33.0%(P=0.0003) risk reduction of all-cause mortality in treatment group than in placebo group(5.19% vs. 7.74% ),in which 54.7% (P=0.0138) risk reduction for tumor death. The incidence of stroke, tumour, and the need for PCI/CABG) were also decreased by 31.1% (P=0.0004) with Xuezhikang than with placebo (6.92% vs 10.04%).Xuezhikang reduced the need for PCI/CABG by 33.3% (P=0.0097) compared with placebo group(3.01% vs 4.51%) . Adverse effects

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