January 21, 2010 (Philadelphia, Pennsylvania) — Red-yeast-rice extract is as well tolerated as pravastatin in patients who previously developed a statin-associated myalgia and withdrew from therapy, research shows . Withdrawals from the red-yeast-rice and pravastatin treatment arms were low; and both groups achieved comparable reductions in LDL-cholesterol levels, report researchers.
"Statin-associated myalgia is an important clinical problem that will likely become more prevalent owing to the ever-expanding indications for statin use," write lead author Dr Steven Halbert (University of Pennsylvania School of Medicine, Philadelphia, PA) and colleagues in the January 15, 2010 issue of the American Journal of Cardiology. "Although no definitive conclusions could be drawn, our data showed that red yeast rice was as well tolerated as pravastatin and achieved clinically significant levels of LDL-cholesterol reduction in a population with previous statin intolerance."
Halbert, along with senior author Dr David Becker (University of Pennsylvania Health System, Philadelphia, PA), previously showed that red yeast rice and a therapeutic lifestyle change significantly reduced LDL-cholesterol levels in statin-intolerant patients with dyslipidemia. As Becker told heartwire at the time, red yeast rice, if properly regulated to control for potential contaminants and regulate consistency between different manufacturers, might represent an option for these difficult-to-treat patients.
Dr Richard Karas (Tufts Medical Center, Boston, MA), who was not part of the study, said that in the real world, statin-associated myopathy is a common and difficult problem for clinicians.
"One of the reasons is that having aches and pains is extremely common in older people," Karas told heartwire . "That circle then intersects with the circle of a lot of older people treated with statins. We don't have a specific test to identify whether a patient is achy because of their statin or because they're older. It's often very difficult for a physician to determine whether that statin should be stopped."
Lovastatin in Certain Types of Red Yeast Rice
In this latest study, Halbert and colleagues wanted to test the tolerability of red yeast rice 2400 mg twice daily in patients who previously discontinued at least one statin, other than pravastatin, because of muscle pain. Extracts of red yeast rice have been widely used in China for therapy in patients with circulatory and digestive disorders for centuries, and preparations of red yeast rice have been shown to lower plasma LDL levels. Lovastatin occurs naturally in certain forms of red yeast rice that are made when the rice is cultivated with the mold Monascus purpureus.
In total, 43 adults with dyslipidemia and a history of discontinuing statins were randomized to red yeast rice or pravastatin 20 mg twice daily for 12 weeks. In addition to the active treatment, patients were also concomitantly enrolled in a 12-week therapeutic lifestyle-change program that emphasized improved nutrition, regular exercise, and relaxation techniques.
After 12 weeks of treatment, red yeast rice reduced LDL-cholesterol levels 30% from baseline, from 181 mg/dL to 126 mg/dL, while pravastatin reduced LDL-cholesterol levels 27%, a nonstatistical difference between treatments. Similarly, there were no significant differences observed in changes in total cholesterol, triglycerides, or HDL-cholesterol levels.
Changes in Lipid Measures From Baseline
|Treatment||Total cholesterol (mg/dL)||LDL cholesterol (mg/dL)||Triglycerides (mg/dL)|
|Red yeast rice|
|Mean percentage change||-23.0||-30.2||-7.8|
|Mean percentage change||-19.6||-27.0||-7.0|
Regarding the primary end point, the incidence of treatment discontinuation because of myalgia, both red yeast rice and pravastatin were equivalent. In the red-yeast-rice arm, one patient of 21 (5%) withdrew because of muscle pain, while two patients of 22 (9%) withdrew in the pravastatin arm. Also, there were no reported differences in the mean pain severity scores with the two treatments.
Halbert and colleagues note that both groups had low rates of recurrent myalgia and that they were unable to show an advantage with red yeast rice compared with pravastatin. They suggest that their initial power calculations, which used the published 50% myalgia recurrence rate for statins, might have been too high. Also, pravastatin, which has hydrophilic properties, might have a lower recurrence rate than other statins, and the 40-mg dose might have been low enough to be well tolerated.
Speaking with heartwire , Karas praised the investigators for attempting to provide efficacy data on a supplement that is used by a large number of people in the US to treat their own LDL-cholesterol levels.
Like Becker, however, he cautioned that red yeast rice, despite the tolerability shown in this trial and despite how difficult it is to treat these patients, is not regulated by the Food and Drug Administration, leading to a lack of consistency from manufacturer to manufacturer. His own preference in treating statin-intolerant patients referred to him is to initiate a long washout of the statin, typically three months, to identify whether the aches and pains are common without the drug, and if so, to try again with a different statin.
"I think the impact of the study is a little difficult to know because basically what they showed was that red yeast rice was as safe as pravastatin," said Karas. "But I think you could interpret that as saying that the vast majority of patients they studied did fine on pravastatin. So the finding isn't really a strengthening of the validity of using red yeast rice as much as saying that, at least in this population-based study, you're perfectly fine putting them on pravastatin, which is a well-controlled, well-regulated product that we have extensive experience with."
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: Red Yeast Rice Comparable to Pravastatin for Statin-Intolerant Patients - Medscape - Jan 22, 2010.