The use of statins to treat cardiovascular disease came under fire when the JUPITER study found that patients on the drug also developed diabetes. This led the FDA to add a diabetes warning label on statins.
To address this concern, researchers from Brigham and Women’s Hospital in Boston began an analysis of the JUPITER trial data. The trial had included 17,600 men and women. The purpose of the reexamination was to see if the benefits of using statin therapy outweighed its risks. Would reductions in heart attack, stroke, and death outweigh the possibility of developing diabetes?
“Unfortunately, little if any data was available at that time to address not only the risks, but also the benefits of treatment,” says Paul Ridker, Director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, in Boston. This is crucial since it is the benefit-to-risk ratio that physicians and their patients need to understand.”
The analysis of JUPITER trial showed that among those took statins and who have one major risk factor for diabetes, there were 134 fewer cases of heart attacks, strokes, and other major cardiovascular problems, but there were 54 cases where diabetes was diagnosed, determined Dr. Ridker.
For those who were not at risk for diabetes, statin therapy has prevented 86 cardiovascular events or deaths with no new cases of diabetes, according to the August 9th issue of The Lancet. The bottomline: statin therapy has a net beneficial result for the participants. This therapy is helpful in addition to a healthier lifestyle.
“The cardiovascular benefits of statin therapy outweigh the diabetes hazard, even among those with highest risks for diabetes,” Ridker said. “We hope these new data will better inform discussions between physicians and patients who are considering the use of statin drugs as a possible addition to diet, exercise and smoking cessation.”
Over the five years of the trial, patients who developed diabetes had at least one risk factor for the disease, while those without risk factors did not show an increased risk for developing diabetes. These risk factors include obesity, family history, and abnormal blood sugar levels.
In addition, Dr. Gregg Fonarow, a spokesman for the American Heart Association and a professor of cardiology at the University of California said that “statin therapy has been clearly demonstrated to prevent cardiovascular events and premature cardiovascular death in men and women.”
“This study confirms there is substantial net benefit of statin therapy even when fully accounting for the diabetes risk,” he added.
However, Ridker and his colleagues note the limitations of the trial by acknowledging that the trial looked specifically at a single statin at a single dose, and the follow-ups occurred at a median of two years after the trial. There is still no long-term assessment of statin therapy.