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A statin a day keeps heart risk at bay, according to findings presented June 6 at the 64th Scientific Sessions of the American Diabetes Association in Orlando, Fla.
Researchers of the Collaborative Atorvastatin Diabetes Study (CARDS) reported that a daily dose of 10 mg of atorvastatin (Lipitor) reduced the risk of a first major cardiovascular event by 37% in patients with type 2 diabetes mellitus, even among those with normal or moderately elevated LDL cholesterol levels.
In addition, patients in the treatment group experienced a 48% reduction in strokes compared to patients taking a placebo.
"This is a very safe and effective treatment that can cut stroke risk in half, cause one-third reduction in coronary artery disease, and it does so even when cholesterol is not high," said co-principal investigator Helen Colhoun, MD, professor of genetics and epidemiology at University College Dublin, Ireland.
Type 2 diabetes is associated with a two- to four-fold risk of cardiovascular disease. About 65% of the 170 million people worldwide who have diabetes will have a heart attack or stroke.
CARDS, sponsored by Diabetes UK, the United Kingdom Department of Health, and Pfizer UK, is described as the first clinical trial of the effectiveness of a lipid-lowering drug focused solely on diabetes patients with no previous history of heart disease, stroke, or particularly high levels of cholesterol (although some patients had cardiovascular risk factors other than diabetes).
The study was conducted at 132 centers in the United Kingdom and Ireland and involved 2,838 men and women aged 40 to 75 years. About one-third of the sites were primary care centers.
Upon entry in the study, the mean LDL level of the treated group was 116 mg/dL, and 25% of the patients in both the treated and the control group had LDL cholesterol below 100 mg/dL, Colhoun reported. Sixty percent of the subjects started with LDL below 130 mg/dL, which is the ADA criterion for definitive pharmacological intervention.
A consistent and persistent lipid-lowering effect was found in the treatment group, with a 40% reduction in LDL, Colhoun reported. "The important point is that throughout the study about 80% of the treatment group had LDL cholesterol below the 100 mg/dL target," Colhoun said. "But the effects of preventative treatment with the active agent for CVD and stroke were, nevertheless, dramatic."
Researchers terminated the trial in June 2003—almost 2 years earlier than the scheduled stop date in 2005—when the study's independent data safety monitoring board noted "clear evidence of efficacy," Colhoun said.
She said that physicians should get away from the idea that starting LDL level should be the primary determinant for statin treatment and to consider the patient's overall cardiovascular risk. It would be a challenge to identify a type 2 diabetes patient who shouldn't receive cholesterol-lowering treatment, Colhoun said
Another report presented, the Analysis and Understanding Diabetes and Dyslipidemia: Improving Treatment (AUDIT), was a survey of 2,000 diabetes specialists in 50 countries. The AUDIT survey noted that physicians do not always consider diabetes patients to have the cardiovascular risk equivalent to that of patients with established coronary heart disease.
According to Colhoun, "Doctors should enter into discussions with type 2 diabetic patients about their risk for heart disease, how to decrease it, and if they would consider statin treatment.... There are few patients with type 2 diabetes who would be reluctant to enter that mode of therapy considering the evidence of efficacy," she said. Although conceding it is not always possible, she added, "It would be ideal if this is a joint decision of the patient and physician."
Asked if the ADA would consider amending its diabetes treatment guidelines on the basis of these studies, immediate Past President Eugene Barrett, MD, noted that the CARDS findings have not yet been published or peer reviewed and that questions still may be raised.
"If I were seeing a patient and measured an LDL less than 50, would I put that patient on a statin? No, I wouldn't," said Barrett, professor of medicine at the University of Virginia. He said that other biology might need to be evaluated, but added that an accumulating body of data shows that statins may have some beneficial effects other than lowering cholesterol.
Donna Lillie, vice president of research and professional education for the Canadian Diabetes Association, said the CARDS results highlight the importance of lowering cholesterol and reducing risk not just for heart disease but also for stroke.
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"Blood glucose remains the cornerstone of diabetes management, but
this disease also requires comprehensive management of blood glucose, blood
pressure, and cholesterol," Lillie said in a statement. 
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