Background: Up to 10 percent of patients using statins may experience statin-associated myalgia. This effect is dose-related and typically occurs without myositis. Adjusting therapy may help (e.g., decreasing or switching statins, or incorporating ezetimibe (Zetia) alone or in combination with colesevelam (Welchol), but no optimal treatment exists for this type of myalgia. Red yeast rice (Monascus purpureus) is a widely available dietary supplement that can decrease low-density lipoprotein (LDL) cholesterol levels, but it has not been studied in patients with statin-associated myalgia.

The Study: Becker and colleagues conducted a prospective, randomized controlled trial using adults with hyperlipidemia and a history of statin-associated myalgia. Eligible patients had discontinued at least one statin because of myalgias. Patients were excluded if they had recently used red yeast rice or a statin, had a history of myositis or rhabdomyolysis, an inability to exercise, elevated transaminase or creatinine phosphokinase (CPK) levels, or coronary artery bypass surgery within the past six months.

Patients were enrolled in a lifestyle change program for the first 12 weeks, and received 1,800 mg of red yeast rice or placebo twice daily for 24 weeks. Pain assessment and laboratory testing were performed at baseline and at the 12-week and 24-week intervals. The primary outcome was effect on LDL cholesterol level, with secondary outcomes including other lipoproteins and weight.

Results: Sixty-two patients with a mean age of 61 years and baseline weight of approximately 179 lb (81 kg) participated in the trial. Pain scores were higher in the placebo group at baseline, although this did not significantly differ between groups at 12 or 24 weeks. Baseline LDL cholesterol levels were statistically equivalent (163 mg per dL [4.2 mmol per L] in the red yeast rice group versus 165 mg per dL [4.3 mmol per L] in the placebo group).

The red yeast rice group showed significantly lower LDL cholesterol levels at 12 and 24 weeks (120 mg per dL [3.1 mmol per L] and 128 mg per dL [3.3 mmol per L], respectively) than the placebo group (154 mg per dL [4.0 mmol per L] and 149.8 mg per dL [3.88 mmol per L], respectively). At week 24, nine patients in the red yeast rice group achieved LDL cholesterol levels of less than 100 mg per dL (2.6 mmol per L), compared with two patients in the placebo group. No notable changes occurred in high-density lipoprotein cholesterol or triglyceride levels, and the groups did not notably differ in developing intolerable myalgias, CPK, or hepatic transaminase levels.

Conclusion: The authors conclude that red yeast rice in conjunction with therapeutic lifestyle change may be useful for treating hyperlipidemia in patients who cannot tolerate statin therapy.