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Joslin’s Allison Goldfine, M.D., Responds to Statin Controversy in NEJM Editorial

Thursday, April 26, 2012

Earlier this year, the FDA placed a warning label on the class of LDL cholesterol-lowering drugs called statins.

The label states that “increases in glycosylated hemoglobin (HbA1c) and fasting serum glucose levels have been reported with statin use,” but continued to say that “FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

This action came as a response to trials data showing an increased incidence of type 2 diabetes diagnoses in patients who had been using statins compared to those using placebo. Combining data from multiple studies suggests that on average, 1 in 255 people on statins for four years were diagnosed with diabetes.

One in 255 may not seem like a lot, but considering approximately 24 million Americans are on one form of statin or another, that would translate to almost 100,000 new cases of type 2 diabetes (assuming none of the patients prescribed a statin already had diabetes).

On the other hand, type 2 diabetes is a treatable disease, and 5,400,000 major cardiovascular events were avoided because of statin use.

This new information has caused a stir in the medical world, and patients who have been on statins for years are starting question whether or not it is the best treatment for them.

Allison Goldfine, M.D., Section of Clinical, Behavioral & Outcomes Research at Joslin Diabetes Center, is responding to the controversy on the New England Journal of Medicine website in her editorial titled “Statins: Is It Really Time to Reassess Benefits and Risks?”

“The decision really comes down to ‘what is the overall risk compared to the overall benefit?’“says Dr. Goldfine.

Having high levels of LDL cholesterol is a major contributor to cardiovascular disease, which is the leading cause of death in the United States. Statins have been used to combat risk of heart disease for a few decades. The drugs interfere with the pathways that create cholesterol, decreasing the production of the so-called “bad” cholesterol.
Because they have been around for so long and are so widely used in the United States, a lot is known about their benefits and drawbacks. However, doctors continue to learn about the use of these drugs.  Only recently has this link between statins and type 2 diabetes been noticed during reviews of large-scale study data.

“Statins are among the most extensively studied medication in people, and I think we really do have a good sense overall of what their benefits are,” said Dr. Goldfine. “Death is reduced, survival is increased. While diabetes is a serious disease, the tradeoffs still look largely favorable for people with risk factors for heart disease because there are fewer heart attacks and people live longer.”

And the majority of people who were diagnosed with diabetes after starting on statins had already exhibited most of the risk factors for type 2 diabetes, including older age and higher fasting blood sugar levels.

“Statins aren’t taking people whose fasting glucose levels are usually 80 mg/dl and making them 300 mg/dl,” said Dr. Goldfine. “From all the studies, it looks like they’re taking people from very close to the diabetic threshold and unmasking it a little bit earlier.”

Why statins increase sugars is still unclear. The genetic pathways of cholesterol production and type 2 diabetes development have zero overlap, so that route is highly unlikely. Some researchers think that statins might affect insulin sensitivity, others wonder if it changes how sugar enters cells. Currently, the most likely potential candidate is that statins somehow alter the processing of beta cell signaling proteins. “But it’s really not well understood,” said Dr. Goldfine. “So there are a bunch of ideas, but none of them are very clear.”

Dr. Goldfine said she’s sure some research will delve into the mechanism behind this phenomenon. But unless new information is uncovered, she sees no real reason to panic. If people are at risk for the suite of problems that could be included in a “cardiovascular event,” they should maintain their use of statins.

“When looking at an approximately 20 percent reduction in the risk of a major vascular event, like a heart attack or need for coronary artery revascularization, and a 16 percent reduction in death, I think the odds are worth it,” she said, both for people who have had a cardiac event or who have multiple risk factors including diabetes.

You can read Dr. Goldfine’s New England Journal of Medicine editorial here

Page last updated: September 19, 2014