The short-term supplementation of monacolin K improves the lipid and metabolic patterns of hypertensive and hypercholesterolemic subjects at low cardiovascular risk

Abstract

Background -The clinical hypocholesterolemic effect of nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5-10 mg of monacolin K is now well established. For this reason, NCs may be a viable alternative to the statin drugs commonly used to lower cholesterol levels. However, in order to avoid some possible statin-like side effects, most NCs available on the market contain low doses of monacolin K, which could reduce their efficacy. The aim of this study was to investigate the efficacy and safety of a NC containing high doses of monacolin K (10 mg) in improving the lipid profile and glucose metabolism when added to the diet versus the diet alone in a group of hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk. Methods -Thirty subjects with grade-1 essential hypertension (mean age 51.5 ± 7.8 years, 62.9% males) were enrolled in the treatment group (NC group). These subjects followed a programmed diet and took one tablet a day of a NC containing red yeast rice, policosanols, resveratrol and chromium picolinate for 1 month and were compared with an equivalent group of subjects that followed only a diet program. Differences in serum total cholesterol (TC), low-density-and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and blood glucose between groups were compared by analysis of variance. Results -In both groups, a significant reduction of TC, TG and LDLC was observed. In the treatment group from the baseline to the follow-up the reduction of TC (230.93 ± 28.0 vs. 188.63 ± 18.1, p < 0.001) and LDLC (153.10 ± 22.5 vs.116.54 ± 17.7, p < 0.001) was significantly greater compared to the control group (differences between treatments = 9.19% and 12.29%, respectively); in addition a significant higher reduction in blood glucose (89.1 ± 7.6 vs. 83.7 ± 4.6, p < 0.001) was also observed (differences between treatments = 4.28%). HDLC levels remained unchanged in both groups. Conclusions -In summary, the NC containing high doses of monacolin K appeared to be safe, well tolerated and effective at improving lipid and glucose patterns.

Safety Evaluation of a New Traditional Chinese Medical Formula, Ciji-Hua’ai-Baosheng II Formula, in Adult Rodent Models

“…Blood biochemical values can vary based on the genotype and sex of laboratory animals [47]. Blood TG is the main biochemical indicator for internal lipid metabolism, and elevated TG is a risk factor for arteriosclerosis, coronary heart disease, and fatty liver [48]. TCHO is the sum of all cholesterols within lipoproteins in blood, which is a reflection of the lipid synthesis and reserve in the liver [49].…”

Effect of Xuezhikang Combined with Rosuvastatin on Lipid Regulation in Patients with Atherosclerotic Cardiovascular Disease: A Real-World Study

“…18 Short term supplementation of monaclin-K can improve blood lipid and lipid metabolism in patients with low cardiovascular risk and hypercholesterolemia. 19 Therefore, western countries take monascus fermentation extract (such as red yest rice) and other nutritional preparations as a bene cial supplement of lipid-lowering therapy for people with statin intolerance or high-dose statins, but do not think that nutritional agents can be used as lipid-lowering drugs alone. 15,20 Xuezhikang is a biological preparation re ned from red koji, which is rich in monacolins, especially cholesterol synthase inhibitor (HMC-CoA).…”

<p>Mini-review: medication safety of red yeast rice products</p>

“…The safety of red yeast rice alone or in combined nutraceuticals has been investigated in clinical trials, where low (3 mg/day) as well as high dose (10 mg/day) regimes of monacolin K were well tolerated by patients with dyslipidemia, with few or no adverse events 25–28. In combination with a low-dose statin therapy, a nutraceutical combination containing red yeast rice has been shown to be tolerated equally to a low-dose statin therapy alone in high-risk patients that were high-dose statin intolerant 29.…”