Coronary artery disease
Effect of Xuezhikang, an Extract From Red Yeast Chinese Rice, on Coronary Events in a Chinese Population With Previous Myocardial Infarction

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Results of well-controlled prospective clinical trials showed the efficacy of lipid-lowering therapies in the reduction of cardiovascular (CV) events in western populations, but they were not reported with a Chinese population. This multicenter study was conducted to determine the effects of Xuezhikang (XZK), a partially purified extract of red yeast rice, on lipoprotein and CV end points in Chinese patients who experienced a previous myocardial infarction. Nearly 5,000 of these patients with average low-density lipoprotein cholesterol levels at baseline were randomly assigned either to placebo or to XZK daily for an average of 4.5 years. The primary end point was a major coronary event that included nonfatal myocardial infarction and death from coronary heart disease. Frequencies of the primary end point were 10.4% in the placebo group and 5.7% in the XZK-treated group, with absolute and relative decreases of 4.7% and 45%, respectively. Treatment with XZK also significantly decreased CV and total mortality by 30% and 33%, the need for coronary revascularization by 1/3, and lowered total and low-density lipoprotein cholesterol and triglycerides, but raised high-density lipoprotein cholesterol levels. In conclusion, long-term therapy with XZK significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths, improved lipoprotein regulation, and was safe and well tolerated.

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Study medication, design, and patients

The study medication consisted of 300-mg capsules of XZK, each containing the combination of lovastatin, also termed monoclonin K (2.5 to 3.2 mg/capsule); a small quantity of lovastatin hydroxyl acid; as well as ergosterol and some other components.

The study protocol was approved by the data and safety monitoring and regional ethics committees of each study site, and informed consent forms were signed by all enrolled patients before study initiation. This randomized, double-blind,

Results

This trial was carried out from May 1996 to December 2003 in 65 hospitals in China, led by the Cardiovascular Institute and Fuwai Hospital at the Chinese Academy of Medical Sciences. Patients (3,986 men, 884 women) were randomly assigned at a ratio of 1:1 into the XZK (n = 2,429) and placebo (n = 2,441) groups. The study plan was to enroll 4,700 patients with 2 interim analyses as prespecified and to discontinue the study upon detection of a significant difference for the primary end point

Discussion

Most large clinical trials with statin therapy examined the impact of about a 25% to 40% fall in LDL cholesterol on the occurrence of CV events and mortality. This relation appears to be greater in patients with rather high levels of LDL cholesterol. The first placebo-controlled multicenter trial with a statin showed a significant decrease in both all-cause mortality and CV events in simvastatin-treated patients with increased serum cholesterol.9 However, because patients with coronary

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Members of the Chinese Coronary Secondary Prevention Study Group are listed in the Appendix.

This study was supported by the Chinese National Scientific and Technological Projects, Peoples Republic of China, and sponsored by WPL Peking University Biotech Co. Ltd (WPU), Beijing, Peoples Republic of China.

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