Blog | Tuesday, May 13, 2014

Europe's take on America's statins guidelines

In November 2013 the American Heart Association released new recommendations on who should be taking “statins” (drugs like Lipitor/atorvastatin), the most common medicines we use to control cholesterol levels. High cholesterol levels are associated with higher risk of heart attacks and strokes, and taking statins, which lower cholesterol, can reduce those risks. The drugs have pretty significant side effects, though, and not everyone with high cholesterol or other cardiac risks will actually have a heart attack or stroke, so it seems clear to most of us that not everyone should take statins.

The American Heart Association’s 2013 guidelines

The new recommendations departed from prior ones in saying that we should prescribe statin drugs to patients with higher risk of heart attacks rather than just patients with high cholesterol. I wrote about the new recommendations here. It actually kind of makes sense, since even patients with relatively normal cholesterol levels may have lower risk of heart attacks when they take statins, and patients who have high cholesterol but no other risk factors may be vanishingly unlikely to have a heart attack regardless of whether they take the drugs. So, theoretically, the new recommendations would allow some people who have been taking statins entirely because of high cholesterol levels to stop taking them, which would be nice.

More statins: good idea or bad idea?

There has been considerable debate since these recommendations were released since they actually significantly increase the number of people who doctors may encourage to take statins. The data on whether giving statins to patients who have never had heart attacks will reduce their risk of heart attack or stroke is pretty weak, and it appears that statin therapy in this group of people does not reduce the risk of death or other disability. (Check out the audio discussion by Dr. John Abramson of Harvard University at The British Medical Journal online since the printed version costs money to read.) Statins appear to be significantly more effective in preventing heart attacks in patients who have already had coronary artery disease, including heart attacks or angina (“secondary prevention”).

Almost all of the data we have on how effective statins might be has been financed, at least in part, by the manufacturers of the drugs, whose primary responsibility is to make money for their shareholders by selling statins, not to make patients live longer and healthier lives. The new recommendations would result in many patients without medical illnesses being starting on medications, what we call “primary prevention.” Patients who are calculated (using a risk calculator) to have a 10-year risk of heart attack or stroke that is greater than 7.5% would be encouraged to take statin drugs.

How many Dutch people would be on statins?

A group of physicians from the department of epidemiology at Erasmus University in Rotterdam, the Netherlands, did a very clever study to look at what effect implementing these new recommendations might have had on a group of random Dutch people (average age 65 or so) they have been following since 1997. Using the data they had collected they found that 100% of the men and 65% of the women would have been recommended to take statins based on risk level.

On average the men were calculated to have a 21.5% 10 year risk of heart attack or stroke based on the calculator and the women 11.6%. They were able to actually look at who had these events, and it turned out, at least for this population, the calculator seriously overestimated the risks. Only 12.7% of the men and 7.9% of the women actually had a heart attack or stroke. (Perhaps Dutch people have lower risk of heart attacks because they ride bicycles more. Physical activity is not entered into the risk calculator.) The authors conclude that using the risk calculator to determine whether to prescribe statins is inaccurate in their population and basically unnecessary over the age of 65 since nearly everyone would receive qualifying scores. They ask if the present guidelines are really advocating a blanket prescription for statins based on age.

Putting it all together

Statins may or may not make us live longer. If they do, it is a pretty small effect unless we have had prior heart attacks or coronary artery disease. They do have side effects. About 1 in 5 people who take them develop some problem, often just muscle pains and weakness but sometimes diabetes and probably thinking and memory problems. The new recommendations released in 2013 by the American Heart Association would have us encourage the majority of people over the age of 65 to take these drugs, as well as quite a few healthy younger people.

Since drug companies are major players in funding research on statins, we may never get truly unbiased information about their risks and benefits. Healthy diet, regular exercise and not smoking are far more powerful ways to reduce risk of heart attack and overall death and disability due to all causes, but advertising this makes nobody any money. It is possible that guidelines that increase the use of statins will also make us just a little weaker, achier, stupid, and diabetic.
