Effects of Xuezhitong in Patients with Hypertriglyceridemia: a Multicentre, Randomized, Double-Blind, Double Simulation, Positive Drug and Placebo Parallel Control Study
Open Access
- 23 March 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Cardiovascular Drugs and Therapy
- Vol. 34 (4), 525-534
- https://doi.org/10.1007/s10557-020-06965-3
Abstract
Backgroud Xuezhitong (XZT) is an extract of Allium macrostemon Bunge that has lipid-lowering properties. Objective To evaluate the effects of XZT on lipids in subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia. Methods A total of 358 subjects with HTG were enrolled and randomly assigned to receive XZT (2700 mg daily), xuezhikang (XZK) (1200 mg daily) or placebo. The primary endpoint was the reduction or percent reduction in the TG level over 12 weeks of treatment. Results At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167). Treatment with XZT capsules also demonstrated superior performance compared with the placebo with respect to the control of lipids (17.97% vs 5.00%), total cholesterol (TC) (14.18% vs 3.89%), low-density lipoprotein cholesterol (LDL-C) (17.98% vs 2.95%), and high-density lipoprotein cholesterol (HDL-C) (21.47% vs 2.16%). Daily use of XZT for 12 weeks resulted in statistically significant (65.22% vs 38.30%, 25.00%; P < 0.0167) and clinically meaningful increases in HDL-C levels by ≥4 mg/dl compared with XZK and placebo. XZT was safe and well tolerated; the safety and tolerability profiles were similar across treatment groups. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase. Conclusions XZT significantly reduced TG levels and was well tolerated. Longer-term studies in more diverse patient populations are needed to corroborate these findings. Clinical Trial Registration www.chictr.org.cn Identifier: ChiCTR1900025854.Keywords
Funding Information
- National Natural Science Foundation of China (81774044)
- Scientific research and innovation team project of Beijing University of Chinese Medicine (2019-JYB-TD-008)
This publication has 21 references indexed in Scilit:
- The prevalence, awareness, treatment and control of dyslipidemia among adults in ChinaAtherosclerosis, 2016
- Fasting Triglycerides Predict Recurrent Ischemic Events in Patients With Acute Coronary Syndrome Treated With StatinsJournal of the American College of Cardiology, 2015
- Effects of Xuezhikang in patients with dyslipidemia: A multicenter, randomized, placebo-controlled studyJournal of Clinical Lipidology, 2014
- Prevalence of dyslipidaemia in patients treated with lipid-lowering agents in China: Results of the DYSlipidemia International Study (DYSIS)Atherosclerosis, 2014
- Gene-Gene Combination Effect and Interactions among ABCA1, APOA1, SR-B1, and CETP Polymorphisms for Serum High-Density Lipoprotein-Cholesterol in the Japanese PopulationPLOS ONE, 2013
- Effects of blood triglycerides on cardiovascular and all-cause mortality: a systematic review and meta-analysis of 61 prospective studiesLipids in Health and Disease, 2013
- Residual Cardiovascular Risk Despite Optimal LDL Cholesterol Reduction with Statins: The Evidence, Etiology, and Therapeutic ChallengesCurrent Atherosclerosis Reports, 2011
- Effects of fibrates on cardiovascular outcomes: a systematic review and meta-analysisThe Lancet, 2010
- Effect of Xuezhikang Capsule (?????) on serum tumor necrosis factor-? and interleukin-6 in patients with nonalcoholic fatty liver disease and hyperlipidemiaChinese Journal of Integrated Medicine, 2010
- A comparison of pravastatin and gemfibrozil in the treatment of dyslipoproteinemia in patients with non-insulin-dependent diabetes mellitusAtherosclerosis, 2002