OBJECTIVEThe mean level of serum cholesterol in Chinese population with coronary heart disease (CHD) is relatively lower compared to that of western population. Our study aimed to evaluate whether lipid-lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in Chinese CHD patients.

METHODSThis study was designed as a random, double-blinded, placebo controlled clinical trial in 66 centers in China and was conducted from may, 1996 to December, 2003. 4870 CHD patients (serum cholesterol level 4.40 - 6.47 mmol/L, age 18 - 75 years, with definite myocardial infarction history) were selected and treated with capsule Xuezhikang (0.6 g Bid) or placebo in addition to conventional therapy (control group). The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and deaths from CHD.

RESULTSIt has been shown at the end of the trial: (1) The incidence of the primary end-points were 5.72% in Xuezhikang treatment group and 10.41% in control group, with a reduction of relative risk by 45.1% for treatment group (P = 0.0000). Among the primary end points, the incidence of deaths from CHD was 3.79% in the treatment group and 5.49% in the control group, with a reduction of relative risk by 31.0% in treatment group (P < 0.0048); (2) The incidence of nonfatal myocardial infarction reduced by 60.8% in treatment group compared to control group (1.93% vs 4.92%, P < 0.0000); (3) The incidence of the secondary end-points (stroke, tumor, PCI/CABG) also decreased by 31.1% in treatment group compared to control group (6.92% vs 10.04% P < 0.0004). Among the secondary end points, the demand for PCI/CABG was 3.01% in the treatment group and 4.51% in the control group, with a reduction of relative risk by 33.3% in treatment group (P = 0.097); (4) The total mortality was lower in treatment group than control group, with a reduction of relative risk by 33.0% in treatment group (5.19% vs 7.74% P = 0.0003). There were no significant differences in side effects and abnormal laboratory references between the two groups.

CONCLUSIONSCompared to placebo, Xuezhikang can significantly decrease the incidence of nonfatal myocardial infarction and deaths from CHD. It can also reduce significantly the demand for PCI/CABG, the total mortality and the deaths from tumor.