Table 4.
Summary of effects of RYR on CVD risks.
| Study | Population | Interventions | Incidence of CV Outcomes | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Revasculariz-Ation | Fatal MI | Non-Fatal MI | Stroke | CV Events a | CV Mortality | All-Cause Mortality | |||
| Clinical trials | |||||||||
| Cui, 2015 [58] | Unstable angina pectoris, statin intolerance n = 90 |
XZK 600 mg BID vs. SMV 20 mg QD vs. SMV stopped and restarted at 20 mg QD Duration = 8 weeks |
– | – | – | – | XZK 3.3% SMV 3.3% SMV stopped 13.3% (p < 0.05 for SMV stopped vs. XZK and SMV) |
– | – |
| Lu, 2008 [69] | Previous MI, average LDL-C levels n = ~5000 |
XZK 600 mg BID vs. PBO Duration = 4.5 years |
33% reduction | – | – | – | XZK 5.7% PBO 10.4% b 45% reduction |
30% reduction | 33% reduction |
| Li, 2010 [70] | Subgroup: previous MI, hypertensive n = 2704 |
XZK 600 mg BID vs. PBO Duration = 4.5 years |
– | XZK 1.0% PBO 1.3% (p = NS) 29% reduction |
XZK 2.2% PBO 5.4% (p < 0.001) 60% reduction |
XZK 3.5% PBO 5.1% (p = 0.06) 32% reduction |
XZK 6.7% PBO 11.9% (p = 0.0214) 43% reduction |
XZK 4.5% PBO 6.5% (p = 0.001) 30% reduction |
XZK 5.9% PBO 9.3% (p = 0.001) 36% reduction |
| Li, 2009 [71] | Subgroup: previous MI, elderly, hypertensive, average LDL-C levels n = 1530 |
XZK 600 mg BID vs. PBO Duration = 4.5 years |
– | – | – | XZK 8.8% PBO 14.3% 38% reduction |
XZK 6.4% PBO 9.0% 29% reduction |
||
| Meta-analyses | |||||||||
| Sungthong, 2020 [72] | Previous MI, borderline hypercholesterolemia n = 10,699 |
RYR 600 mg BID vs. PBO Duration = 4 weeks to 4.5 years |
RR 0.58 (95% CI 0.48, 0.71) p < 0.00001 42% reduction |
RR 0.78 (95% CI 0.55, 1.10) p = 0.16 22% reduction |
RR 0.42 (95% CI 0.34, 0.52) p < 0.00001 58% reduction |
– | – | – | – |
| Yuan, 2022 [73] | Metabolic syndrome n = 5440 |
XZK vs. control (PBO or routine treatment) Duration = 4 weeks to 4.5 years |
– | – | – | – | MACE: RR 0.54 (95% CI 0.43, 0.66); p < 0.00001 46% reduction |
– | RR 0.62 (95% CI 0.49, 0.78); p < 0.0001 38% reduction |
| Real-world retrospective cohort study | |||||||||
| Chang, 2022 [74] | No history of stroke n = 69,446 |
RYR vs. LOV Duration = NR |
– | – | – | – RYR 3.97/1000 PYs LOV 6.99/100 PYs 35% reduction |
– | – | – |
a Includes non-fatal MI, fatal MI, and death; b Includes non-fatal MI and deaths from CHD. BID = twice daily; CHD = coronary heart disease; CI = confidence interval; CV = cardiovascular; CVD = cardiovascular disease; LDL-C = low-density lipoprotein cholesterol; LOV = lovastatin; MACE = major adverse cardiac events; MI = myocardial infarction; NR = not reported; NS = not significant; PBO = placebo; PY = person-year; QD = once daily; RR = risk ratio; RYR = red yeast rice; SMV = simvastatin; XZK = Xuezhikang.