A surgeon prepares a blue cord that will be inserted in the inflated abdomen of a patient through a port (lower right) as he performs a laparoscopic gastric bypass at Rose Medical Center in Denver August 30, 2010. Credit: Reuters
New U.S. 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 drugs that lower cholesterol or even bariatric weight loss surgery.
The guidelines issued by two leading U.S. medical organizations on 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 No. 1 killer in the country.
They stopped short of setting lower target levels for "bad" LDL cholesterol of 70 or lower, and focused instead on identifying high risk patient groups likely to most benefit from more intensive treatment with cholesterol lowering statin drugs.
The long-awaited new guidelines announced by the American College of Cardiology (ACC) and American Heart Association (AHA) came in the form of four reports: one on managing blood cholesterol; one on managing overweight and obese patients; one for assessing cardiovascular risk in adults; and one on heart disease prevention through healthy lifestyle.
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. Since the experts did not consider clinical data or scientific evidence available later than 2011, they plan to begin work updating the guidelines next year.
The cholesterol management guidelines, if followed in practice, 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 lead to reduced use of lower dose generic statins and perhaps far less use of non-statin cholesterol medicines, such as Merck's Zetia and AbbVie's Tricor, which the report said lacked evidence of reducing heart attacks and death.
Merck has a large study underway of its Vytorin combination cholesterol treatment that should definitively prove whether use of Zetia prevents heart attacks and strokes.
"Non-statins 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; 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.
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 healthcare 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 insurance companies are expected to cover counseling and other obesity treatments.
"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 U.S. guidelines is likely to help justify coverage for the procedures by health insurers.
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 Inc and Vivus Inc's Qsymia. Those medicines were not considered for the guideline reports as they were not available by 2011.
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-intensity aerobic exercise three to four times a week, and a diet in which levels of saturated fat, trans fat and sodium are below what is currently consumed by the average American. The U.S. 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.