Medical Tribune August 2008 SFIX
David Brill
A compound extracted from red yeast rice can significantly reduce the risk of coronary events among patients with a history of myocardial infarction (MI), a randomized trial involving 4,870 Chinese patients has demonstrated.
The magnitude of the effect surpasses that previously reported for statin monotherapy, according to the authors of the study which was published in The American Journal of Cardiology.
Major coronary events occurred among 10.4 percent of patients who took placebo and 5.7 percent of those who took the extract – correlating to a relative decrease of 45 percent and an absolute decrease of 4.7 percent.
The compound, known as Xuezhikang (XZK), was also associated with a 30 percent reduction in risk of cardiovascular death and a 33 percent reduction for total mortality. The average treatment duration was 4.5 years.
“This study shows very clearly that the results exceed that which you would find with any of the statin studies done with patients that have average cholesterol levels,” said Dr. David Capuzzi, one of the authors of the trial, which was conducted at 65 hospitals across China.
“I think it’s very promising. I would be surprised, quite frankly, if this turned out not to be an excellent product.”
He added that the closest comparable study is the Cholesterol and Recurrent Events (CARE) trial, which demonstrated that taking pravastatin led to a 24 percent reduction in risk and an absolute difference of 3 percent. [N Engl J Med 1996 Oct 3;335(14):1001-9]
XZK, which is produced by the Beijing WBL Peking University Biotech Co. Ltd., contains lovastatin, lovastatin hydroxyl acid and ergosterol, among other components. Patients who took 600 mg of XZK orally twice a day also showed significant decreases in triglyceride and LDL cholesterol levels and increases in HDL cholesterol levels compared to those who took placebo.
Dr. Paul Chiam, an associate consultant in the Department of Cardiology at the National Heart Centre Singapore, said that XZK has the potential to become a useful drug for patients who need lipid lowering treatment.
“XZK appears to be at least as effective and perhaps more effective than conventional statins reported in previous studies.
“However, the population in this study was different from studies of statins in the literature, and only a direct randomized head-to-head comparison between XZK and a well established statin, such as simvastatin, would resolve the question whether XZK is indeed more effective,” he said.
Chiam added that although XZK appears to be well tolerated, longer-term safety data are still required. At present a statin would still be first choice for the majority of patients, he said.
Capuzzi, who is based at the Lankenau Institute for Medical Research in Pennsylvania, US, stressed that XZK is extracted from rice grown under controlled laboratory settings and that the results cannot necessarily be extrapolated to commercially-available red yeast rice which may contain unknown compounds.
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