Experts Question Link Between Statin Use and Diabetes

Researchers from Florida Atlantic University and Harvard Medical School suggest that the benefits of using statins in the treatment and primary prevention of heart attacks and strokes outweighs the risk of diabetes.

“There is general consensus about the large and persuasive body of evidence that statins are effective and safe in reducing cardiovascular morbidity and mortality in secondary and primary prevention as well as among patients with diabetes," the investigators wrote in the commentary. Nevertheless, they added, "there is controversy about real and perceived risks of statins."
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The authors sought to determine whether there is a valid statistical association between statin use and the risk of developing diabetes, and, if so, whether a causal judgment is warranted, as well as to explore the implications of these findings for clinicians.

Led by Charles H. Hennekens, MD, DrPH, a professor and senior academic advisor to the dean at the Florida Atlantic University Charles E. Schmidt College of Medicine, the researchers found that by 2012, none of 27 published trials had been designed a priori to test the hypothesis, and just 6 of them mentioned newly diagnosed diabetes. “Thus, any findings on statins and diabetes from any such individual trials or their meta-analyses, should be considered hypothesis generating, not testing," the authors wrote, adding that 2 of the individual trials reported statistically significant findings and 4 did not.

The range of the confidence interval suggests that any risk is likely to be as low as 2% and no higher than 17%, the authors said, adding that, "even assuming that the findings were real, 255 patients would have to be treated with a statin for four years before even one patient would be diagnosed with diabetes. In these same 255 patients, 9 major nonfatal and fatal vascular events would have been prevented.” Thus, the authors concluded that the benefits of statins far exceed the potential risk of diabetes, even when assuming causality.

"We believe that the totality of evidence regarding statins and newly diagnosed diabetes should be viewed as hypothesis-formulating, not hypothesis testing," the researchers wrote.

"Clinicians should also consider that, even if the current insufficient totality of evidence were judged to be causal, the possible but unproven small risks of statins and newly diagnosed diabetes pale in comparison to the clear and conclusive benefits of statins on vascular disease outcomes, especially in subjects with diabetes or at high risk of being diagnosed with diabetes,” they wrote.

"Statins are perhaps the most well-studied medications in modern cardiovascular medicine," said coauthor Marc A. Pfeffer, MD, PhD, a professor of medicine at Harvard Medical School.

"Documentation of [statins'] effectiveness in reducing morbidity and mortality along with their safety and tolerability profiles has led to recommendations from multiple guidelines for use in both primary and secondary prevention," Dr Pfeffer said. "However, physicians understand that their N=1 patient recommendation should be based on shared decision-making. In my opinion, for most, the decision to augment prudent lifestyle choices with a statin can be anticipated to result in a better prognosis."

—Mark McGraw

Reference:

Hennekens CH, Teng B, Pfeffer MA. Statins and diabetes: current perspectives and implications for clinicians [published online January 14, 2017]. Am J Med. doi: http://dx.doi.org/10.1016/j.amjmed.2016.12.022.