Chinese red yeast rice is a dietary supplement containing monacolins, unsaturated fatty acids, and phytosterols capable of lowering low-density lipoprotein (LDL) cholesterol. Few studies have reported on its use in clinical practice or in statin-intolerant patients. We reviewed approximately 1,400 clinical charts and identified 25 patients treated with red yeast rice for ≥4 weeks. The patients were included if they had pre- and post-treatment lipid levels without simultaneous changes in other lipid-lowering medications. These patients had experienced myalgias (68%), gastrointestinal intolerance (16%), and/or elevated alanine aminotransferase levels (8%) with previous use of other lipid-lowering agents. The total cholesterol decreased 15% (−37 ± 26 mg/dl, p <0.001) and LDL cholesterol decreased 21% (−35 ± 25 mg/dl, p <0.001) during 74 ± 39 days of treatment. Most (92%) patients tolerated the treatment, and many (56%) achieved their LDL cholesterol goal. In patients unable to tolerate daily statin use, the total cholesterol level decreased 13% (−33 ± 10 mg/dl, p <0.001) and LDL cholesterol decreased 19% (−31 ± 4 mg/dl, p <0.001). In conclusion, red yeast rice modestly decreased total and LDL cholesterol, was well-tolerated, and was an acceptable alternative in patients intolerant of other lipid-lowering medications.
The 3-hydroxy-3-methylglutaryl (HMG) co-enzyme A reductase inhibitors (statins) are the most commonly prescribed medications to treat elevated low-density lipoprotein (LDL) cholesterol levels. However, 10% of patients have reported muscle-related side effects in the clinical setting. Chinese red yeast rice is a dietary supplement made by fermenting the yeast, Monascus purpureus , over rice. Monascus yeast produces a family of substances called monacolins capable of inhibiting the enzyme 3-hydroxy-3-methylglutaryl co-enzyme A reductase and also contains unsaturated fatty acids and phytosterols, all capable of lowering LDL cholesterol. The present report reviewed our clinical experience using red yeast rice in a lipid clinic with a population intolerant to daily statins.
Methods
We reviewed the clinical charts of approximately 1,400 patients referred to the Hartford Hospital Cholesterol Management Center and identified 25 patients treated with red yeast rice for ≥4 weeks. The patients were included if they had pre- and post-treatment lipid level measurements that were ≥4 weeks apart without simultaneous changes in other lipid-lowering medications. In addition to lipid levels, alanine aminotransferase (ALT) and creatine phosphokinase (CPK) were measured in clinical chemistry laboratories. Patients were treated with an over-the-counter red yeast rice preparation of their choice at a dose of 1,200 mg at bedtime. These red yeast rice preparations were bought by the patients in local retail stores. The risk categories and LDL cholesterol therapeutic goals were assigned using the 2001 National Cholesterol Education Program Adult Treatment Panel III guidelines. Descriptive statistics (mean ± SD) were calculated for continuous data. A significant lipid level change with red yeast rice was established using paired Student’s t tests. Significance was set at p <0.05.
Results
Total cholesterol decreased 15% (−37 ± 26 mg/dl, p <0.001) and LDL cholesterol decreased 21% (−35 ± 25 mg/dl, p <0.001) during 74 ± 39 days of treatment. Triglycerides and high-density lipoprotein cholesterol decreased 6% (p = 0.06) and 0.5% (p = 0.48), respectively ( Table 1 ). Patients with initial LDL cholesterol levels in the highest tertile (mean LDL cholesterol 198 ± 27 mg/dl) experienced an 18% LDL cholesterol reduction (−36 ± 3 mg/dl, p = 0.006), those in the second tertile (mean 168 ± 18 mg/dl) a 30% LDL cholesterol reduction (−49 ± 17 mg/dl, p <0.001), and those in the lowest tertile (mean LDL cholesterol 123 ± 52 mg/dl) a 16% LDL cholesterol reduction (−21 ± 15 mg/dl, p = 0.01; Figure 1 ). Of the 25 patients, 56% achieved their LDL cholesterol goal.
| Variable | Before Treatment (mg/dl) | After Treatment (mg/dl) | Change (%) | p Value |
|---|---|---|---|---|
| Total cholesterol | 250 ± 39 | 214 ± 48 | −15 ± 10 | <0.001 |
| Low-density lipoprotein cholesterol | 164 ± 35 | 129 ± 38 | −21 ± 14 | <0.001 |
| High-density lipoprotein cholesterol | 59 ± 21 | 58 ± 20 | −0.5 ± 12 | 0.48 |
| Triglycerides | 146 ± 68 | 134 ± 59 | −6 ± 21 | 0.06 |
Most patients were women (68%) and white (96%) and had a mean age of 62 ± 10 years. All but 2 patients were in the moderate (64%) (≥2 risk factors and 10-year risk <20%) or high risk (28%) (coronary artery disease or coronary artery disease risk equivalent) National Cholesterol Education Program categories for coronary artery disease. Patients treated with red yeast rice had experienced myalgias (68%), gastrointestinal intolerance (16%), and elevated ALTs (8%) with previous use of other lipid-lowering agents. Of the 17 patients with myalgias, none were able to tolerate daily statin use, and 53% had intolerance to daily ezetimibe. Total cholesterol decreased 13% (−33 ± 10 mg/dl, p <0.001) and LDL cholesterol decreased 19% (−31 ± 4 mg/dl, p <0.001) in these 17 patients with myalgia.
Chinese red yeast rice was tolerated by 92% of the population, including 89% of patients with a history of myalgias. One patient reported myalgia and another “abdominal bloating.” Alanine aminotransferase was elevated initially in 2 patients that persisted at follow-up testing, but these levels were <2 times the upper limit of normal (ULN). The greatest post-treatment CPK level was 130 mg/dl.
Results
Total cholesterol decreased 15% (−37 ± 26 mg/dl, p <0.001) and LDL cholesterol decreased 21% (−35 ± 25 mg/dl, p <0.001) during 74 ± 39 days of treatment. Triglycerides and high-density lipoprotein cholesterol decreased 6% (p = 0.06) and 0.5% (p = 0.48), respectively ( Table 1 ). Patients with initial LDL cholesterol levels in the highest tertile (mean LDL cholesterol 198 ± 27 mg/dl) experienced an 18% LDL cholesterol reduction (−36 ± 3 mg/dl, p = 0.006), those in the second tertile (mean 168 ± 18 mg/dl) a 30% LDL cholesterol reduction (−49 ± 17 mg/dl, p <0.001), and those in the lowest tertile (mean LDL cholesterol 123 ± 52 mg/dl) a 16% LDL cholesterol reduction (−21 ± 15 mg/dl, p = 0.01; Figure 1 ). Of the 25 patients, 56% achieved their LDL cholesterol goal.
