An international study on the potent cholesterol lowering statin drug rosuvastatin has shown that it is also effective at halting the early stages of atherosclerosis in people at low risk for heart attacks and strokes.
The results of the study, which is called METEOR (Measuring Effects on intima media Thickness: an Evaluation of Rosuvastatin), are to be published in the March 28 issue of the Journal of the American Medical Association, and were announced at the annual meeting of the American College of Cardiology in New Orleans.
Rosuvastatin, currrently marketed by AstraZeneca PLC as Crestor, is a relatively new drug in the family of drugs known as statins. Statins are used to reduce cholesterol and other blood fats, and have been shown to slow down plaque build up in the arteries of patients who have had a heart attack or are already at high risk due to high cholesterol. But this was the first study to test Crestor on low risk patients with moderate cholesterol levels.
Scientists did ultrasound imaging tests on 5,751 people with no symptoms and found 984 showing signs that plaque was starting to build up in the arteries that feed blood to the brain and entered them into the trial. 702 were randomly assigned to take 40 mg of Crestor every day and 282 were randomly assigned to a placebo group.
The male trial participants were aged from 45 to 70 and the females from 55 to 70. They were were considered to be at low risk of heart attack or other life-threatening cardiac event, and had no reason to take statins for lowering cholesterol.
The result of the 2-year trial showed that Crestor stopped the plaque from building up even further. But it did not reverse the process, as AstraZeneca had hoped.
Dr John R. Crouse, lead researcher and a professor of endocrinology at Wake Forest University School of Medicine in North Carolina, said that Crestor (rosuvastatin), “arrested the progression of thickened carotid arteries compared to a placebo. The findings show that the benefits of cholesterol management on arteries can be extended to low-risk patients”.
The trial results also showed that Crestor reduced “bad” cholesterol or low-density lipoprotein by 49 per cent, and increased “good” cholesterol or high density lipoprotein by 8 per cent. Another blood fat group, triglycerides, were also reduced by 16 per cent. Crestor stopped the plaque build up on all 12 sites of the arteries that were tested.
Dr Crouse explained that, “Atherosclerosis is often advanced before symptoms appear and it hasn’t been clear whether treatment of low-risk individuals is beneficial”, however, he said “This study shows that aggressive cholesterol management arrests the progress of even small changes in the arteries”.
He added that, “The drug was well tolerated during the two-year period and showed a similar safety profile to the placebo”.
The frequency of side-effects and adverse events were similar in the active and placebo drug group and included muscle pain and gastrointestinal disorders.
The trial recruited patients from 61 primary care practices in the US and Europe and took place between August 2002 and May 2006. The patients were examined by ultrasound at the start and every six months of the trial.
All patients were considered of low risk, that is having a less than 10 per cent chance over a 10 year period of having a heart attack or dying from a heart -related event. Risk was calculated from factors such as age, sex, blood pressure and cholesterol levels using a formula developed by the National Cholesterol Education Program from the long-running Framingham Heart Study.
According to AstraZeneca, Crestor has been approved in over 90 countries and has been prescribed for over 9 millions patients worldwide. Clinical trials and usage data shows its safety profile is in line with other marketed statins.
The study was funded by AstraZeneca.
Written by: Catharine Paddock
Writer: Medical News Today