Title:Effects of Xuezhikang versus Pravastatin on Triglyceride Level in Patients
with T2DM and Dyslipidemia: Study Protocol for a Multicenter Randomized
Controlled Trial
Volume: 21
Issue: 3
Author(s): Jin Xu, Liyuan Zhu, Yingying Xie, Miao Zhang, Zixi Xiao, Rongkai Su, Tie Wen and Ling Liu*
Affiliation:
- Department of Cardiovascular Medicine, the Second Xiangya Hospital, Central South University, Hunan, 410011, China.
- Research Institute of Blood Lipid and Atherosclerosis, Central South University, Hunan, 410011, China.
- Modern Cardiovascular Disease Clinical Technology Research Center of Hunan Province, Hunan, 410011, China.
- Cardiovascular Disease Research Center of Hunan Province, Hunan, 410011, China
Keywords:
Diabetes, triglyceride, dyslipidemia, hypertriglyceridemia, cardiovascular risk, diabetes.
Abstract:
Background: Hypertriglyceridemia, is commonly found in patients with diabetes. Xuezhikang,
an extract of red yeast rice, is effective in reducing cardiovascular events in Chinese patients with
diabetes and coronary heart disease (CHD). Xuezhikang has been reported to significantly decrease the
level of triglycerides (TG), a potential causal risk factor for myocardial infarction. On the basis of a
similar reduction in low-density lipoprotein cholesterol, this study will evaluate the effect of xuezhikang
on TG levels compared with pravastatin in patients with type 2 diabetes mellitus (T2DM) and
dyslipidemia.
Methods: This is an open-label, multicenter, randomized controlled study to assess the effects of
xuezhikang (1.2 g/day) and pravastatin (20 mg/day) on TG and other blood lipid parameters in patients
with T2DM and dyslipidemia. A total of 114 patients will be enrolled and randomly assigned 1:1 to
receive xuezhikang or pravastatin treatment for 6 weeks.
Result: The primary outcome measure is the change from baseline in fasting TG levels after 6 weeks.
The change from baseline in other fasting and postprandial lipid parameters, and glucose profiles at 1, 2,
and 4 h after a nutritious breakfast will also be explored.
Conclusion: This study will evaluate the effect of a 6-week treatment with xuezhikang compared with
pravastatin on fasting and postprandial TG levels and other blood lipid parameters in patients with
T2DM and dyslipidemia without atherosclerotic cardiovascular disease (ASCVD). The results will provide
more information on optimizing the lipid control of patients with diabetes in the primary prevention
of ASCVD.
