Millions of Americans going for an annual checkup in 2014 will come away from the doctor’s office with a new prescription to lower their cholesterol, a move cardiologists say will avert heart attacks and strokes.
New guidelines released by the American Heart Association and the American College of Cardiology will expand the use of statin drugs to almost 1 in 3 Americans from 16 percent currently. Everyone older than 40 with diabetes and those diagnosed with heart disease should be on a statin, regardless of their cholesterol count, the recommendations say.
As many as 15 million Americans will be told to start taking statins, a class of medicines including AstraZeneca Plc (AZN)’s Crestor and generic drugs that can cost as little as 10 cents a day. Others may be weaned off treatments that work differently, such as Merck & Co. (MRK)’s Zetia, that were prescribed to get them to the now abandoned targets for lower cholesterol. The guidelines also will ask more from patients, including an extra effort to improve their lifestyles.
“This does represent a sea change,” said Rob Schwartz, a cardiologist at the Minneapolis Heart Institute who treats patients and conducts research. “There is no longer a focus on single numbers as far as your goal. That’s a two-edged sword because it’s easy to understand. The problem is that life isn’t that simple.”
Jennifer Decamps, an emergency room nurse at Deaconess Hospital in Evansville, Indiana, said she has taken a statin for six of the last 10 years. As a nurse and a Type 1 diabetic, the 39-year-old Decamps is well aware of her risk. She said the “guidelines change is frustrating,” because she’s not sure how they will affect her.
“I know the importance of the cholesterol numbers and what the drugs can do,” she said. “I don’t know for me personally whether the recommendation matters or changes treatment.”
The guidelines recommend a move away from treating patients to a preset goal, optimally under 100 milligrams per deciliter for bad cholesterol, known as LDL, and less than 70 mg/dl for those with heart disease. Now it’s advised that patients stay on statins no matter what their levels.
The biggest challenge will be educating doctors and patients about the changes, said Dave Dixon, a clinical lipid specialist at Virginia Commonwealth University’s School of Pharmacy in Richmond. Patients like numbers and goals to shoot for, and many doctors believe the lower the LDL, the better. It’s not clear how people will respond to the changes, he said.
The National Lipid Association has already rejected the guidelines, saying their focus on rigorous studies that excluded other types of evidence was insufficient to address gaps in patient care. The group said there wasn’t evidence to support the decision to eliminate treatment targets.
Primary care physicians may be slow to embrace the new guidelines, Dixon said. Patients, meanwhile, should take a list of questions to their next visit to find out exactly what their risk is and what their prescriptions are supposed to do.
“I do have some concern from the standpoint that it’s such a drastic change,” Dixon said. “If there is a split amongst the medical community, I’m not sure that’s the best thing for our patients. They are going to get mixed messages.”
Patients on multiple medications should ask about the goals of treatment, particularly now that it isn’t to get cholesterol to a pre-determined level, he said. Some patients may have their medications reduced. That is already happening for some people, after a study found adding AbbVie Inc. (ABBV)’s Niaspan to a statin failed to help patients and may have raised the risk of stroke.
The changes are under way at the nation’s Veterans Affairs hospitals, which last year conducted a review and altered their approach. The VA system recognized cost and patient benefits, said John Rumsfeld, the national director for cardiology at the U.S. Veterans Health Administration in Denver.
“When the VA got rid of this performance measure and moved to a statin-based treatment, we found that fewer patients were being overtreated with unproven medications,” Rumsfeld said. “This cuts costs for the health-care system because it reduces both repeat blood tests and extra medication prescriptions.”
The VA doctors were initially surprised and a bit resistant to the change, Rumsfeld said. The approach was embraced after the rational and the simplified methods were explained, he said. Doctors are already asking patients about their risk of heart attack and stroke, diabetes, high blood pressure and smoking. Using that information to determine whether someone needs cholesterol treatment wasn’t a burden, he said.
“Ultimately, it’s a simplified approach,” Rumsfeld said. “We get patients started on the treatment, and then we don’t make the treatment and its monitoring a burden.”
Many people don’t realize the new guidelines still have targets for the degree of cholesterol reduction that doctors are shooting to hit. Intensive statin therapy for high-risk patients should lower cholesterol by at least 50 percent, while moderate therapy should cut it by 35 percent to 50 percent, Dixon said.
Only Crestor and high doses of atorvastatin, the generic name for Pfizer Inc. (PFE)’s Lipitor, can generate a 50 percent or greater reduction, he said. For patients who can’t tolerate high doses or don’t benefit enough, doctors should get creative, he said. This is the only group where non-statin therapies, like Merck’s Zetia and Vytorin, are considered for care.
Half of all heart attacks happen in people with normal cholesterol, said Schwartz, of the Minneapolis Heart Institute. While cholesterol is a good marker of risk, it doesn’t identify everyone. Conversely, many people with elevated cholesterol levels based on the old guidelines will never have any heart trouble or a stroke, he said.
Also, patients will be reminded that a large part of their risk is under their own control, with weight loss, smoking cessation and exercise playing key roles.
“Prevention of heart disease is more than a number,” Schwartz said. “The numbers still matter, but it’s a lifestyle. It’s a necessary move away from just numbers to look at the whole patient. People like to be able to take the magic bullet, but it’s just not that simple.”
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