Effect of xuezhikang on cardiovascular events and mortality in elderly patients with a history of myocardial infarction: a subgroup analysis of elderly subjects from the China Coronary Secondary Prevention Study.

OBJECTIVES: To evaluate whether lipid-lowering therapy with xuezhikang reduces the risk of coronary events and total mortality in patients with coronary heart disease (CHD) aged 65 and older. DESIGN: Subgroup analysis of the China Coronary Secondary Prevention Study, a randomized, double-blind, placebo-controlled, clinical trial. SETTING: Sixty-six hospitals in China. PARTICIPANTS: A total of 1,445 patients, aged 65 to 75, were chosen from 4,780 patients with a history of myocardial infarction. INTERVENTION: The patients were randomized to the xuezhikang (n=735) or the placebo (n=710) group and followed for a mean of 4 years. MEASUREMENTS: The primary endpoint was recurrent coronary events; the secondary endpoint was all-cause mortality and other clinical events, including adverse effects. RESULTS: Elderly patients were at greater risk for coronary events, death from coronary events, all-cause mortality, and malignancies than younger patients. Xuezhikang therapy reduced the incidence of coronary events 36.9% (P=.001), death from coronary heart disease 31.0% (P=.04), all-cause mortality 31.9% (P=.01), stroke 44.1% (P=.04), the need for a percutaneous coronary intervention or coronary artery bypass graft 48.6% (P=.07), and malignancies 51.4% (P=.03). Based on the treatment of elderly patients with xuezhikang for an average of 4 years, the number needed to treat (NNT) to prevent one coronary event, one coronary death, and one mortality due to all causes was estimated to be 18, 33, and 23, respectively. In a like manner, the estimated NNT to prevent one coronary event, one coronary death, and one mortality due to all causes in younger patients was 23, 82, and 51, respectively. There was not a significantly greater number of adverse effects in the xuezhikang group than in the placebo group. CONCLUSION: This is the first study demonstrating that treatment with xuezhikang capsules is safe and effective for the secondary prevention of CHD in older Chinese people.

Xuezhikang, an extract of cholestin, reduces cardiovascular events in type 2 diabetes patients with coronary heart disease: subgroup analysis of patients with type 2 diabetes from China coronary secondary prevention study (CCSPS).

Lipid-lowering therapy has been proven to reduce macrovascular complications of type 2 diabetes. Xuezhikang is an extract of cholestin and has a markedly modulating effect on lipids, but the effect of xuezhikang on reducing coronary events in diabetic patients with coronary heart disease (CHD) is less clear. A total of 591 diabetic patients with CHD were randomized to the xuezhikang group (n=306) and the placebo group (n=285). During the average 4 years of follow-up, there were 28 cases of CHD events (9.2%) in the xuezhikang group and 53 cases (18.6%) in the placebo group. Risk reduction for CHD events was 50.8% (P<0.001) by xuezhikang treatment. Xuezhikang decreased the risk of non-fatal MI by 63.8%, fatal MI by 58.5%, CHD sudden death by 26.9%, and other CHD death by 53.4%. CHD death totaled to 21 cases in the xuezhikang group (6.9%) and 35 cases in the placebo group (12.3%), indicating that xuezhikang significantly decreased the risk of CHD death by 44.1% (P<0.05). Seventy-two patients died from various causes, among which there were 27 patients in the xuezhikang group and 45 patients in the placebo group. The risk for all-cause death was 44.1% lower in the xuezhikang group than in the placebo group (P<0.01). This investigation demonstrates that xuezhikang therapy can be effective on reduction of cardiovascular events in diabetic patients with CHD with a reliable safety.

[China coronary secondary prevention study: analysis of patients with different myocardial infarction history].

OBJECTIVE: To assess whether Xuezhikang was effective in the secondary prevention of coronary heart disease (CHD) for patients with different length of myocardial infarction (MI) history. METHODS: 2135 patients with MI history of 28 days to 3 months and 2735 patients with MI history of 3 months to 60 months were recruited separately to receive treatment with Xuezhikang capsule or placebo. The primary end-points were nonfatal myocardial infarction and death from CHD. RESULTS: The occurrence of coronary events were found to be not statistically significantly different for the two groups of patients. For patients with MI history of 28 days to 3 months, Xuezhikang significantly reduced the risk of CHD events by 56.7% (P < 0.0001) and resulted in a 48.6% (P = 0.0002) risk reduction in all-cause mortality as compared with placebo. For patients with MI history of 3 months to 60 months, Xuezhikang significantly decreased the risk of CHD events by 35.3% (P = 0.0008) and led to a 20.0% (P = 0.1181) risk reduction in the all-cause mortality as compared with placebo. Adverse effects and abnormal laboratory parameters did not differ significantly in the two groups of patients. CONCLUSIONS: Xuezhikang is more effective for patients with MI history of 28 days to 3 months as compared with patients with MI history of 3 months to 60 months. Patients with MI history should be treated with Xuezhikang early in order to achieve better prevention of CHD.

[The beneficial effects of lipid-lowering therapy with xuezhikang on cardiac events and total mortality in coronary heart disease patients with or without hypertension: a random, double-blinded, placebo controlled clinical trial].

OBJECTIVE: To evaluate whether lipid-lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in coronary heart disease (CHD) patients with or without hypertension. METHODS: In this random, double-blinded, placebo controlled clinical trial, 2704 patients with hypertension and 2166 patients without hypertension were enrolled and capsule Xuezhikang 0.6 g Bid or placebo on the top of conventional therapy without other lipid-lowering drugs. The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and total mortality. RESULTS: Compared to placebo group, the incidence of cardiac events was reduced by 44.0% (P<0.0001) and 47.4% (P<0.0001) respectively in CHD patients with or without hypertension, and the total mortality was lowered by 35.8% (P=0.0012) and 28.6% (P=0.0737) respectively in CHD patients with or without hypertension. There was no significant difference in side effects between study groups. CONCLUSION: Xuezhikang can reduce the cardiac events and mortality in CHD patients with or without hypertension.

[China coronary secondary prevention study (CCSPS): outcomes from analysis of coronary heart disease patients with diabetes].

OBJECTIVE: To elucidate whether lipid-lowering therapy with Xuezhikang can induce a decrease of cardiac events and an attenuation of total mortality in coronary heart disease (CHD) patients with diabetes. METHODS: We designed a random, double-blinded, placebo controlled clinical trial in selected 591 patients. All patients were administrated with capsule Xuezhikang (0.6 g, Bid) or placebo in addition to conventional therapy. The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and death from CHD. RESULTS: (1) The incidence of CHD events and that of death from CHD were reduced by 50.8% (P = 0.0008) and by 44.1% (P = 0.0246) in treatment group, respectively; Also, the incidence of nonfatal myocardial infarction was reduced by 63.8% (P = 0.0151). (2) The incidence of stroke, tumor, and PCI/CABG were decreased by 20.2%. (3) The total mortality were lowered by 44.1% in treatment group (P = 0.0097). CONCLUSION: Xuezhikang can effectively reduce the incidence of cardiac events and total mortality in CHD patients with diabetes.