Cardiovascular Benefits of Taking Statins Outweigh Diabetes Risk
No risk for those without diabetes risk factors, one risk factors jumps risk 28%
Aug. 10, 2012 - The benefits of taking statins to reduce the risk of cardiovascular disease outweigh the increased risk
of developing diabetes experienced by some patients who take these cholesterol-lowering drugs, according to an Article published Online First
in The Lancet. Those with major risk factors for diabetes should be cautioned.
A team of scientists led by Professor Paul Ridker, based at Brigham and Women's Hospital, Boston, USA, analyzed data
gathered during JUPITER, the first controlled study to report that taking statins results in an increased risk of developing diabetes. This
finding, subsequently confirmed by several other studies, led to the US Food and Drug Administration (FDA) enforcing a compulsory warning on
statin labels, advising users of the increased risk of diabetes.
Professor Ridker and colleagues analyzed the JUPITER results to determine whether or not the risk of developing diabetes
was outweighed by the benefits to cardiovascular health conferred on patients who took statins over the five year trial period. They found
marked differences in the likelihood of developing diabetes, depending on whether or not the patient was already at risk of developing
diabetes when the trial began.
FDA on Statins & Diabetes
Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies
showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with
type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone
needed to convert food into energy. If the pancreas doesn't make enough insulin or if cells do not respond
appropriately to insulin, blood sugar levels in the blood get too high, which can lead to serious health problems.
A small increased risk of raised blood sugar levels and the development of Type 2 diabetes
have been reported with the use of statins.
“Clearly we think that the heart benefit of statins outweighs this small increased risk,”
says Egan. But what this means for patients taking statins and the health care professionals prescribing them is
that blood-sugar levels may need to be assessed after instituting statin therapy,” she says.
Patients who had at least one risk factor for diabetes were 28% more likely to develop diabetes when using statins,
compared to patients in the control group. However, there was no discernible increase in the risk of developing diabetes for patients who did
not have any risk factors for diabetes.
Although the use of statins clearly increased the likelihood of developing diabetes in patients already at risk of the
disease, these patients were still 39% less likely to develop cardiovascular illness while using statins, and 17% less likely to die over the
Patients who were not already at risk of developing diabetes experienced a 52% reduction in cardiovascular illness when taking statins, and had no increase in diabetes risk.
According to Professor Ridker, "Our results show that in participants with and without diabetes risk, the absolute
benefits of statin therapy are greater than the hazards of developing diabetes. We believe that most physicians and patients would regard
heart attack, stroke and death to be more severe outcomes than the onset of diabetes, and so we hope that these results ease concern about the
risks associated with statin therapy when these drugs are appropriately prescribed – in conjunction with improved diet, exercise and smoking
cessation – to reduce patients' risk of cardiovascular disease."
In a linked Comment, Professor Gerald Watts of the University of Western Australia's Cardiometabolic Research Centre,
Royal Perth Hospital, suggests that if further work confirms the findings from the new Lancet study, the FDA may wish to consider restricting
their warning about the increased risks of diabetes to people with existing major risk factors for the disease.
However, according to Professor Watts, "A major take-home message for the clinician involved in either primary or
secondary prevention of cardiovascular disease is that all individuals on a statin who have major risk factors for diabetes, particularly
impaired fasting glucose, need to be informed about the risk, monitored regularly for hyperglycemia, and advised to lose weight and take
regular physical exercise to mitigate the emergence of diabetes."
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