New cholesterol guides may put 13 million more Americans on the drugs

When new guidelines were released last fall on the prevention and treatment of heart disease, some predicted their approach would greatly increase the numbers of people taking cholesterol-fighting drugs called statins. Indeed, an additional 12.8 million U.S. adults could receive or become eligible for statin therapy under the full implementation of the guidelines, according to a study published in the New England Journal of Medicine.

The study, by researchers at Duke University, was the first independent look at how many more patients would become eligible for statins under controversial guidelines released in November by the American Heart Association and the American College of Cardiology. Many of the newly eligible are adults 60 and over without cardiovascular disease — in other words, a group that faces a more nuanced risk-benefit analysis than those who have already had a stroke or heart attack, for whom the decision to take statins may be more clear-cut.

Yet just because people meet certain criteria for statin therapy doesn’t necessarily mean they should start treatment, the guideline authors have stressed. (The Duke researchers took no position on whether patients should take statins or not, conducting instead a quantitative analysis of how many new patients would become candidates if the guidelines were fully implemented.) The decision to take cholesterol drugs involves a discussion with a doctor. And the whopping numbers out of Duke suggest that many more patients than before may be initiating that discussion with their health-care providers.

Today, among people age 50 to 64, about 30% of men and 22% of women have prescriptions for cholesterol-fighting drugs. The Duke study shows how these numbers could climb under the new guidelines, which advocate a holistic approach that incorporates factors such as age, race and lifestyle when calculating a person’s risk of developing heart attack and stroke.

The prior approach involved targeting specific levels of LDL, or “bad cholesterol,” to gauge the success of managing of cardiac risk. “We’ve brainwashed a generation of patients to look intently at a number,” said Dr. Harlan Krumholz, a cardiologist and professor of medicine at Yale School of Medicine. “This guideline has taken a very different approach, and it makes many people uncomfortable.”

Among adults between the ages of 60 and 75 without cardiovascular disease who are not receiving statin therapy now, 87.4% of men would be eligible for such therapy under the new guidelines, up from 30.4% under the old; for women, the numbers would rise to 53.6% from 21.2%, according to the Duke study.

Under the new guidelines, an overall increase in statin use among those ages 40 to 75 could prevent some 475,000 extra cardiovascular events, such as heart attacks and strokes, over the next 10 years, according to Michael Pencina, a professor of biostatistics at the Duke Clinical Research Institute and lead author of the study.

That decrease would benefit patients and their families, as well as a society looking for ways to reduce health-care spending. One consequence, Pencina said, is many additional people taking statins who might never have had a heart attack or stoke without them.

So what’s the risk of taking statins that you might never have needed? Many doctors agree these drugs are generally safe and effective. “There are very few medications that have been studied as carefully as this class of drugs,” said Dr. Neil Stone, Bonow professor of medicine-cardiology at Northwestern University Feinberg School of Medicine, who chaired the writing committee for the new guidelines.

Side effects of statins include muscle pain and — more rarely and seriously — contributing to the development of Type 2 diabetes. Some patients can tolerate certain statins but not others for individual reasons, doctors say, and then finding a good fit involves trial and error.

Cost is generally not a big factor, as most statins are available in cheap, generic form. But if a patient can tolerate only a statin currently without a generic equivalent, such as AstraZeneca’s Crestor, the costs can be more substantial. A three-month supply of Crestor can cost more than $700; even though health insurance will typically cover a portion of these costs, patients’ out-of-pocket expenses can add up over the years.

Then there’s patient psychology. Some people simply don’t like taking pills, and no amount of doctor cajoling will change their minds. Others like to feel they’re doing everything they can to improve their health and want to take medication even when their cardiac risks are relatively low.

Doctors should respect patients’ views, Krumholz said, and the new guidelines allow for a broader discussion than the past emphasis on test results. For one, patients who feel like their doctor fully listened to their concerns may be more likely to stick with treatment. And yet doctors should also support those who decide against treatment, Krumholz said.

Individual preference becomes even more important in older patients, Krumholz said. The recent guidelines were based on a review of the scientific evidence focused on patients ages 40 to 75, and there simply isn’t that much data on patients in their late 70s and beyond, he said.

Those wanting to discuss statin use with their doctor might consider scheduling an appointment for that purpose, Krumholz said. This goes for those currently on statins and those not taking them who wonder if they might be candidates under the new guidelines.

Questions to ask your doctor, Krumholz suggested, are “What’s the potential benefit of this medication” and “How many people need to be treated for one person to benefit?”

One misconception about the new guidelines is that doctors will no longer take patients’ cholesterol panel, or the blood tests that measure various cholesterol levels, Stone said. Doctors should still take those readings, he noted, in part to check whether patients on medication are taking it as prescribed.

Written by Elizabeth O’Brien and published by MarketWatch, March 27, 2014.

FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U. S. C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www. law. cornell. edu/uscode/17/107. shtml“