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 withxuezhikang 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.
RCT Entities:
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.