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Diabetes risk not a reason to avoid statins

Friday August 10, 2012
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The cardiovascular and mortality benefits of statin therapy outweigh any increase in risk of diabetes, according to a study.

Earlier this year, study data raised concern that statin therapy can be associated with an increased risk of diabetes.

"Our data indicate that the risk of developing diabetes while on statin therapy was limited almost entirely to people who had at least one major risk factor for diabetes prior to initiating statin therapy," Paul M Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and lead author of the new study, said in a news release. "Yet even in this high-risk group, the benefits of treatment in terms of life-threatening cardiac events avoided greatly outweighed the diabetes hazard."

"What matters for optimal patient care is the balance of risk and benefit," Ridker added. "The new data will inform physician-patient discussion and ease concern about risks associated with statin therapy when these drugs are appropriately prescribed for cardiovascular risk reduction in addition to dietary discretion, increased exercise and smoking cessation."

The researchers evaluated data from the contemporary JUPITER trial, a multinational, randomized, double-blind study in which 17,603 men and women with no previous cardiovascular disease or diabetes received either a statin (rosuvastatin 20 mg daily) or a placebo and were followed for up to five years. Researchers tracked the number of people who developed diabetes while on treatment and the number of people who experienced a myocardial infarction, stroke, invasive cardiac revascularization procedure, deep vein thrombosis, pulmonary embolism or death from any cause.

For the analysis, researchers categorized study participants into those at low or high risk for developing diabetes, the latter defined as having at least one major diabetes risk factor such as impaired fasting glucose, metabolic syndrome, severe obesity or elevated HbA1c.

Ridker and his colleagues reported that in patients without a risk factor for diabetes, rosuvastatin was associated with a 52% reduction in major cardiovascular events (such as MI, stroke, coronary revascularizations or cardiovascular death) and no increase in diabetes. In these individuals, 86 vascular events or deaths were avoided with zero cases of diabetes diagnosed.

In patients with a major risk factor for diabetes, rosuvastatin was associated with a 39% reduction in MI, stroke, coronary revascularizations, and cardiovascular death. In these participants, a total of 134 vascular events or deaths were avoided for every 54 new cases of diabetes diagnosed.

Overall, among those randomly allocated to statin treatment instead of placebo, the time to diagnosis of diabetes increased by 5.4 weeks. In current practice guidelines, most diabetic patients already are considered to be candidates for statin therapy.

"Whether there is a microvascular risk associated with this extra 40 days of treatment remains unknown" Ridker said. "We know with certainty, however, that large vessel events like heart attack and stroke are clearly reduced with early and more aggressive therapy."

The researchers noted a limitation of their study was that all patients involved had an elevated high-sensitivity C-reactive protein level, an inflammatory risk factor for the development of both type 2 diabetes and cardiovascular events.

Ridker and his colleagues encourage additional research that focuses on the unknown biological mechanisms that underlie the association between statin use and diabetes risk. Ridker also emphasized that exercise and dietary discretion remain the most important issues for preventing both diabetes and heart disease, and that no drug treatment is a substitute for these critical lifestyle issues.

The study appears in the Aug. 11 issue of The Lancet. To read the summary and access the study via subscription or purchase, visit http://bit.ly/P5cWPV.

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