Long-Term Effects of Xuezhikang on Blood Pressure in Hypertensive Patients with Previous Myocardial Infarction: Data from the Chinese Coronary Secondary Prevention Study (CCSPS)

Abstract

Several previous trials from Western population studies have showed that statins may help reduce blood pressure (BP). However, randomized clinical data is limited. Xuezhikang, a partially extract of red yeast rice, contains a family of naturally occurring statins, and has a marked impact on lipids, but it is unknown whether Xuezhikang has any effect on BP during long-term follow-up in the Chinese population. This is a post-hoc subgroup analysis of a randomized, double-blinded, placebo-controlled, parallel group clinical trial, Chinese Coronary Secondary Prevention Study (CCSPS). A total of 2704 hypertensive patients with previous myocardial infarction (MI) were assigned either to placebo (n == 1341) or to Xuezhikang (n == 1363) daily for an average of 4.5 years. The primary outcome was the unadjusted changes in mean arterial pressure (MAP) from baseline to 6 months. We also assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure. Analysis of covariance was used to calculate the adjusted effects of treatment on changes in these outcomes at 6, 12, 24, and 48 months post-random- ization, after controlling for potential confounders. This analysis included 2704//4870 (55.5%%) hypertensive patients for whom BP was measured at baseline and at least one follow-up visit after randomization. Median duration of the follow-up was 4.5 years (54 months), and 25 patients (0.92%%) were lost to the last follow-up because of adverse effects. The results showed that the unadjusted and adjusted changes in MAP, SBP, DBP, or pulse pressure from baseline were not significantly different for Xuezhikang or placebo recipients at 6, 12, 24, and 48 months after randomization. In this post-hoc subgroup analysis, we failed to demonstrate any significant reducing effects of Xuezhikang on BP in Chinese hypertensive patients with previous MI, suggesting that further prospective study on the effects of statins on BP would be needed, especially in high-risk patients.

• Xuezhikang
• coronary artery disease
• blood pressure
• statin
• clinical trial

ACKNOWLEDGMENTS

This study was supported by the project (No. 96-906-02-10) of the National Medical Science and Technological Foundation during the ninth 5-year plan in China. Dr. Jian-Jun Li, Dr. Zong-Liang Lu, Wen-Rong Kou, Zuo Chen, Yang-Feng Wu, Xue-Hai Yu, and Yu-Cheng Zhao received financial support by grants from the National Medical Science and Technological Foundation, and Beijing WBL Peking University Biotech Co., Ltd. for the present study.

Declaration of interest: The sponsors partially funded the study but had no input into the design, subject recruitment, data collections, analysis, or preparation of the manuscript.