New guidelines on heart health that were a decade in the making recommend stronger measures for patients at particularly high risk of heart attack or stroke, including more aggressive therapy with cholesterol-lowering drugs and bariatric weight-loss surgery.
The recommendations issued by two leading U.S. medical organizations Tuesday are likely to be followed by cardiologists and primary care physicians, as well as influence insurance coverage. They still emphasize a healthy diet and exercise as keys to avoiding the nation's No. 1 killer.
They stopped short of setting a lower target level for "bad," LDL, cholesterol and focused instead on identifying high-risk patient groups likely to benefit the most from intensive treatment with cholesterol-lowering statin drugs.
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The American College of Cardiology (ACC) and American Heart Association (AHA) issued the guidelines in the form of four reports: managing blood cholesterol; managing overweight and obese patients; assessing cardiovascular risk in adults; and preventing heart disease through healthy living.
The project was begun by the National Heart, Lung and Blood Institute, which studied and compiled data before handing off to ACC and AHA this year to translate findings into clinical practice guidelines and publish the reports. Because the experts did not consider clinical data or scientific evidence available later than 2011, they plan to begin work updating the guidelines next year.
If followed in practice, the cholesterol management guidelines could lead to more extensive use of high-potency statins such as AstraZeneca's Crestor and higher doses of Pfizer's Lipitor, now available as generic atorvastatin. They could also result in reduced use of lower-dose generic statins and perhaps far less use of nonstatin cholesterol medicines, such as Merck's Zetia and AbbVie's Tricor, which the report said lacked evidence of reducing heart attacks and death.
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Merck has a large study underway of its Vytorin combination cholesterol treatment, which should prove definitively whether use of Zetia prevents heart attacks and strokes.
"Nonstatins didn't provide enough risk prevention," Dr. Neil Stone, lead author of the cholesterol report, said in a conference call. He noted that there has been "over treatment by drugs not proven to add incremental benefit."
The four groups deemed most likely to benefit from higher-intensity statin treatment were patients with known heart disease; those with an LDL level of 190 or higher; patients with type 2 diabetes between the ages of 40 and 75; and those between 40 and 75 deemed to have a 10-year risk of developing heart disease of 7.5 percent or higher based on new risk-assessment formulas.
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With nearly 155 million Americans classified as overweight or obese, treating the obesity epidemic was a cornerstone of the new guidelines. Obesity, which leads to diabetes, heart disease and other serious health problems, adds an estimated $190 billion in annual medical costs, according to health-care economists.
The guidelines still use body mass index (BMI), a measure of ideal weight in relation to height, to identify patients at high risk of developing heart disease. It strongly recommends in-person counseling as part of programs to help patients maintain weight loss, with 14 sessions over six months seen as ideal.
Under President Barack Obama's Affordable Care Act, commonly referred to as Obamacare, most private insurers are expected to cover counseling and other obesity treatments.
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"Telling patients or advising patients that they need to lose weight is not enough," said Dr. Donna Ryan, co-chair of the obesity report writing committee.
Counseling should focus on patients with other conditions that heighten the risk of heart disease, such as high blood pressure, high cholesterol, diabetes, or a waist circumference of more than 35 inches for women and 40 inches for men, the obesity management report said.
The most drastic recommendation said bariatric weight loss surgery for adults with a BMI of at least 40—or 35 or higher for those with two other risk factors such as high blood pressure or diabetes—may provide significant health benefits. Adding that recommendation to the guidelines is likely to help justify coverage for the procedures by health insurers.
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Another recommendation for reducing heart risk said there should be a focus on achieving sustained weight loss of 5 percent to 10 percent within the first six months.
"Physicians should counsel patients that lifestyle changes that produce even modest weight loss can result in clinically meaningful health improvements," Ryan said.
The new guidelines could help boost sales of two new prescription weight loss drugs—Belviq, from Arena Pharmaceuticals, and Vivus' Qsymia. Those medicines were not considered for the guideline reports as they were not available by 2011.
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The panel looked at about 17 different weight loss diets before deciding not to recommend any specific ones.
"We came down loud and clear that there is no ideal diet for weight loss and there is no superiority for any of the diets that we examined," Ryan said.
The healthy living clinical practice guidelines for lowering heart disease risk called for 40 minutes of moderate to vigorous aerobic exercise three to four times a week, and a diet in which levels of saturated fat, transfat and sodium are below what is currently consumed by the average American. The Food and Drug Administration last week proposed banning trans fat from processed foods.
Not surprisingly, the report recommends a diet that emphasizes fruits, vegetables, whole grains, fish and nuts while limiting red meat, sweets and sugar-sweetened beverages.