Type II diabetes puts people at a higher risk for both heart disease and stroke, and increases their chance of dying from these problems. One way to prevent cardiovascular problems is through the use of drugs called statins, which lower cholesterol levels. The most popular of this group is Lipitor, or atorvastatin, and is prescribed for many medical conditions relating to cholesterol and cardiovascular disease but not usually for people with diabetes who do not have cardiovascular problems. Researchers from the University College Medical School in London wondered if it should be prescribed more often.
What they wanted to know: Does atorvastatin prevent cardiovascular disease in patients with Type II diabetes?
What they did: The researchers studied about 2,800 people, all of whom had Type II diabetes and at least one additional cardiovascular risk factor, such as hypertension or cigarette smoking. Half of the sample received one 10-mg tablet per day of atorvastatin and the other half took a placebo. The patients continued on that regimen for an average of four years. The researchers saw patients monthly for the first three months, at six months, and once every six months after that. They measured cholesterol levels and recorded the incidence of heart attacks, strokes, and other cardiovascular problems.
What they found: Patients taking atorvastatin were 37 percent less likely to have a major cardiovascular problem such as a heart attack and were 48 percent less likely to have a stroke than the patients taking a placebo. The patients on atorvastatin had a substantial reduction in their cholesterol levels, while the placebo patients showed only a mild reduction (possibly because some of them used other statins during the study). During the study, 82 people in the placebo group died versus 61 in the atorvastatin group, and the trial was ended early because the placebo group wasn't getting the apparent benefits of atorvastatin.
What it means to you: This study advocates putting all people with Type II diabetes on an atorvastatin, reasoning that most have risk factors for cardiovascular disease. In addition, it attacks the current guidelines by groups such as the American Diabetes Association that recommend cholesterol-lowering drugs only for people with high cholesterol. However, these drugs may not be worthwhile for people with relatively low cholesterol and low risk for cardiovascular problems, says Abhimanyu Garg, a doctor from the University of Texas, in a commentary in the same issue of the journal that reported the findings. For those people, reducing cholesterol using diet and exercise may be just as good, and much cheaper than using drugs.
Caveats: Pfizer, the company that makes Lipitor, provided the drugs, and a representative from the company sat on the steering committee, which could vote on how the study was done. Six of the 10 authors have served as consultants or been given money from Pfizer, as has the University College of London. That doesn't necessarily make the conclusions wrong, but Pfizer certainly has a lot to gain if statins are recommended for more people.
Find out more: The American Diabetes Association has a website with a good overview of the risks and treatments for Type II diabetes.
Medline, a service of the National Institutes of Health, has a description of Lipitor and its uses.
Read the articles: Colhoun, H.M. et al. "Primary Prevention of Cardiovascular Disease With Atorvastatin in Type 2 Diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): Multicentre Randomised Placebo-Controlled Trial." The Lancet. Aug. 21, 2004, Vol. 364, No. 9435, pp. 685-696.
Garg, A. "Statins for All Patients With Type 2 Diabetes: Not So Soon." The Lancet. Aug. 21, 2004, Vol. 364, No. 9435, pp. 641-642.
Abstract online: http://www.thelancet.com