New heart-disease guidelines leave doctors and patients confused about statins.

For those who CHOOSE to ‘live’ under the influence of BigPharma. REMEMBER: It is YOUR health – and YOUR Choice! (Ed.)

Many doctors and patients were surprised last November when two major medical groups upended one central element of the traditional approach to warding off heart disease. With the release of new guidelines, the American Heart Association and the American College of Cardiology shifted away from the prior focus on “bad cholesterol”—and proposed changes to the way doctors prescribe statins, the highly successful cholesterol-fighting medications.

The guidelines recommend a more holistic approach, but some critics said they could greatly increase the number of patients taking statin medication. Now that the dust from the ensuing brouhaha has begun to settle, what should patients expect when they visit the doctor?

For more than 20 years, doctors have been telling patients that to lower their risk for heart attack, stroke and death from heart disease, they must reduce their levels of LDL, known as “bad cholesterol,” to less than 100 milligrams per deciliter or even, in some cases, less than 70. To that end, among people age 50 to 64, about 30% of men and 22% of women currently have prescriptions for cholesterol-fighting drugs.

In what some experts have described as a tectonic shift, the two medical groups now advocate a broader approach that looks at overall risk, including factors such as race and lifestyle. The guideline authors said that after an extensive, yearslong review of the literature, they found little scientific evidence to support LDL target levels.

That conclusion unsettled some patients and doctors who had long relied on those targets. “The new guidelines take away one of the anchors patients have used, which is, ‘if I get my LDL numbers to the target, I’m in the clear,’” said Dr. Larry Gassner, a doctor of internal medicine in Phoenix who is affiliated with MDVIP, a network of physicians that’s a unit of Procter & Gamble. “The new guidelines say cholesterol is very important, but it is only a piece of the puzzle.”

Controversy over the new guidelines has complicated this puzzle, with some critics saying the medical community should hold off on implementing the recommendations. The guidelines’ authors, meanwhile, say some of their positions have been misunderstood.

Pharmaceutical companies also have interests at stake in the new guidelines. Some may stand to benefit if the drugs are more widely prescribed, though analysts note that much of the statin market is dominated by generic drugs whose profit margins are relatively low. Among top-selling statins, Crestor, made by AstraZeneca, is still under patent protection; Lipitor, made by Pfizer Inc., and Zocor, made by Merck & Co., are not.

Redefining who’s at risk
Part of the controversy centers on a new risk calculator that gauges patients’ likelihood of developing heart disease or stroke within 10 years. Some say that the calculator over-represents many people’s risk and could lead to people taking statins unnecessarily, or taking a higher dose than needed.

Cost is rarely an impediment to statin use these days, as most statins are available in cheap, generic form. Indeed, many experts see statins as a very cost-effective way of warding off much more dangerous—and expensive—health complications.

At the same time, “these are potent medications—getting it right is critical,” said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who has advocated suspending the implementation of the new guidelines to allow for more discussion. Statins have been shown to have some side effects in certain patients, such as muscle pain, and—more rarely and seriously—contributing to the development of Type 2 diabetes.

Despite their disagreement, both sides agree on some basics. Low-density lipoprotein, or LDL, is still considered “bad” cholesterol. It forms a fatty plaque that can clog the arteries, contributing to heart disease. No one disputes that heart disease is a major problem, the leading cause of death for both men and women in this country, according to the Centers for Disease Control and Prevention. And few physicians would argue that preventing heart disease, in part through a healthy, tobacco-free lifestyle, is preferable to treating the condition once it has developed.

The new guidelines recommend statins for four groups, many of whom would already be given the medication under the prior recommendations. These include: those with diabetes who are between ages 40 and 75; people who already have heart disease; and people with primary LDL elevations of 190 milligrams per deciliter or more. (Such primary elevations are usually due to genetics rather than to other conditions that can increase LDL numbers, such as hypothyroidism.)

Under the new guidelines, some in these groups might see their statin dosage increased, if their bodies can tolerate it, to get the optimal benefit, 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.

The gray area lies largely with those in a fourth category: patients between ages 40 and 75 without cardiovascular disease or diabetes who score a 7.5% or above on the new risk calculator. Some critics say that 7.5% risk of developing heart disease or stroke within 10 years is a low threshold for statin use. (African-Americans and women are more likely than other groups to have a stroke before a heart attack, Stone said.) “It’s a significant lowering” of the prior standard, Nissen said, and might capture some who wouldn’t be best served by taking statins.

Dr. Miles Varn, chief medical officer of PinnacleCare, a private health advisory firm based in Baltimore, said it’s not necessarily bad if more people are considered at risk for heart disease under the new guidelines, as long as that determination helps prevent heart attacks and stroke. Varn said the pluses of statins “overwhelmingly” outweigh the risks.

Test-driving the guidelines
Gassner had recent occasion to put the new guidelines to the test with a patient who came to his office for the first time. The white, 72-year-old male had healthy cholesterol and blood pressure numbers and didn’t smoke. He was about 15 pounds overweight but otherwise in excellent health and not on statins. Yet he scored an 18.6% on the new calculator, suggesting he would be a candidate for statins. (Age plays a big role in a patient’s risk calculation under the new scoring system, and many men in their late 60s and beyond would be considered statin candidates based largely on their age and not necessarily their cholesterol levels, some doctors said.)

Gassner and his patient weren’t confident that statins would meaningfully lower the man’s risk. Instead, Gassner recommended that he exercise a bit more and eat fewer carbohydrates. If the patient makes no progress toward these relatively modest goals in a few months, Gassner said he’d consider prescribing statins.

That is exactly the type of approach that physicians should take toward the new guidelines, Stone said. He said risk scores of 7.5% and over had been misinterpreted as absolute triggers for statin use, when in fact that level indicates a potential benefit that must be put into a broader context. “Calculators don’t write prescriptions—doctors do,” Stone said. He acknowledged the risk calculator did overestimate risk in some patients, but he said those affected by the errors were already high-risk and likely to be on statin medication anyway.

Instead, the guidelines recommend that doctors consult with their patients and weigh their individual potential for benefit from statins versus the potential harm. Stone said he didn’t envision many more patients going on statins under the new guidelines. In fact, he said, the removal of the prior, “arbitrary” LDL targets means some patients, such as those with borderline readings, could actually come off medication.

Patients should discuss the new heart disease prevention guidelines with their primary care doctors, regardless of whether they’re taking statins, experts say. Some ways to broach the conversation at your next visit include, “New cholesterol guidelines are out—how do they apply to me?” and “What would it take to reduce my risk of heart attack and stroke?”

For his part, Gassner said he planned to wean his patients off targeting LDL numbers, but only slowly. “There’s an inherent loss of faith when the rules change,” he said. “I try to maintain a stable environment for my patients.”

Written by Elizabeth O’Brien and published at Market Watch, January 8, 2014.

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