By Linda Marsa
Photo by emagineart/Flickr
Tristan Marquez is trim and physically active and, at age 55, has no signs of heart disease. But last fall, when her total cholesterol measured 260 and the so-called bad LDL cholesterol hit 173, her physician wanted to immediately start her on a cholesterol-lowering statin.
Marquez, a Los Angeles real estate agent, decided to first try to bring the numbers down without pills. She now loads up with fruits and vegetables, scrutinizes package labels to steer clear of saturated fats and salt, and hits the gym at least three times a week. “I live like a monk,” says Marquez. “If my doctor tells me to take a statin, I will. But I’d prefer to correct this without drugs.”
Like Marquez, millions of Americans who don’t have heart disease – and who might not even have elevated cholesterol – may be startled to be handed a prescription at their next checkup. Last November, the American Heart Association and the American College of Cardiology issued sweeping new guidelines for staving off heart disease, which, as the nation’s number one killer, will claim 600,000 lives this year. The new rules, in a revolutionary change aimed at improving prevention, significantly lowered the threshold at which someone’s risk profile is considered worrisome enough to merit medication, while doing away with specific cholesterol target numbers and hitting hard on lifestyle changes instead.
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The shift could more than double the number of statin takers to 56 million, according to a Duke University study. The potent statins now making up the therapeutic arsenal – including Zocor, Lipitor, Crestor and Pravachol – work by reducing the amount of cholesterol produced by the liver. They can shrink LDL cholesterol by up to 60 percent, boost levels of the “good” artery-clearing HDL cholesterol, prevent the buildup of perilous fatty plaques, and reduce triglycerides, blood clotting and inflammation, all of which contribute to heart disease.
Under the previous guidelines, healthy people were advised to keep total cholesterol under 200 milligrams per deciliter and their LDL to a max of 160; 130 to 159 was borderline. Anyone with heart disease was encouraged to bring the LDL number down to less than 100; whittling it down to 70 was even better. People at some risk, who are obese or who have high blood pressure, for example, were told to aim for 130 or less. Based on a complicated formula that factored in five key risks (age, smoking history, blood pressure, HDL level and family history), people whose predicted likelihood of a heart attack over the next 10 years was 20 percent or greater were advised to consider drugs.
The updated recommendations expand the risk factors to include race, using a new online estimator to spit out a person’s 10-year and lifetime chances of being hit by heart attack and dying from cardiovascular disease, and, for the first time, of suffering a stroke. And they set the bar for a serious talk about statins at just 7.5 percent. Since up to 80 percent of cardiovascular disease is caused by unhealthy lifestyle habits such as smoking, carrying around extra pounds, eating fat-laden foods (story, Page 72) and being a couch potato, everybody is advised to stick to a healthy diet and get 40 minutes of exercise three or four times a week, cut back on salt, reduce sugar intake and keep saturated fat to 5 or 6 percent of calories.
“We got rid of the [cholesterol] targets because we couldn’t find evidence for any single number,” says Neil Stone, chairman of the expert panel convened to formulate new guidelines on managing cholesterol and a professor of preventive cardiology at Northwestern University’s Feinberg School of Medicine. “But we found strong evidence for optimizing lifestyle and optimizing the best therapy, statins,” for people at risk. The guidelines also discourage the use of popular nonstatin drugs often prescribed to improve cholesterol levels, like niacin, Zetia and fibrates, as first-line therapies. Data on their effectiveness isn’t as extensive or impressive as that on statins.
From virtually the minute they were released, the guidelines expanding statin use have stirred up controversy. For people in the high risk category – they’ve had a heart attack or stroke; have undergone an angioplasty or bypass surgery; or have diabetes, clogged arteries, heart-related chest pain or off-the-charts LDL – the cholesterol-busters are lifesavers. Statins cut by about 25 percent the odds that these folks will have a cardiac event within the next 10 years, numerous studies show, and the risk of dying from heart disease is reduced by 15 to 20 percent if they take the meds for the rest of their lives.
But for people who are otherwise healthy, experts argue that the scientific evidence is pretty thin that statins help. “If you’ve had a heart attack, you need a statin. The evidence is overwhelming,” says Steven Nissen, former president of the American College of Cardiology and a cardiologist at theCleveland Clinic. “In people who haven’t had a heart attack but still have high risk factors, like diabetes, there is very clear evidence that some of them will benefit. But exactly where you draw the line is very controversial.” In his own practice, Nissen continues to prescribe statins on a case-by-case basis.
If the new recommendations are followed to the letter, then nearly 13 million more people could be on the cholesterol lowering pills, according to a 2014 analysis by Duke Clinical Research Institute scientists, in addition to the estimated 43 million Americans who are eligible under the previous rules (right now, only about 25 million people actually do take them). This would translate to almost half of all U.S. adults between the ages of 40 and 75. For otherwise healthy adults over age 60, the proportion would rise to 77 percent, versus about 48 percent under the old standard. But this could save lives, according to Duke University biostatistician Michael Pencina, the lead author of the study. Over 10 years, he says, up to 475,000 heart attacks, strokes and cardiovascular deaths could potentially be prevented.
The new approach, which also for the first time tailors the risk calculations for African-Americans, is aimed at capturing the type of patients that keep doctors up at night: the seemingly healthy people who die suddenly of heart attacks every year. More than 500,000 Americans will suffer their first attack this year, and many will have had no previous warning signs.
“It’s one thing to have an intellectual discussion, but I take care of patients who’ve had heart attacks and strokes, and they would have been happy to take these pills for 10 years,” says Mariell Jessup, president of the American Heart Association and a cardiologist at the University of Pennsylvania. “One out of 3 Americans will die of a heart attack or stroke, and half of Americans will have a heart attack or stroke in their life. It doesn’t seem excessive to try and identify more patients at risk.”
But there’s also a concern that the new method overstates the risk in people like Tristan Marquez. Even if it’s accepted that everyone who meets the new target threshold of a 7.5 percent 10-year risk should take a statin, that translates to 92.5 percent odds that people at this risk level won’t have a stroke or heart attack in the time frame. Two Harvard researchers analyzed the algorithms used to predict these 10-year risks by looking at what actually happened to people, crunching the numbers from three large studies that followed more than 100,000 people for decades. They uncovered a systematic overestimation of risk – many people in the real world who would have been deemed high risk by the new assessment tool never had any problems. And virtually all African-American men over the age of 65, even those healthy otherwise and at low risk, would be given statins. This translates to possibly tens of millions of patients on the cholesterol-busters who don’t really need them.
In a subsequent analysis earlier this year, scientists with the Cochrane Review collected the data from 18 different studies that encompassed nearly 57,000 people without signs of cardiovascular disease taking statins for prevention. Of 1,000 people on medication for five years, researchers found, 18 would avoid a major heart attack or stroke, or 1.8 people out of 100. “We’re talking about 5,000 patient years of treatment to avoid 18 events if the evidence we have is accurate,” says John Ioannidis, an epidemiologist at Stanford University School of Medicine. “Statins are among the most effective drugs we have, but many of the additional people who are now being offered these medications may not benefit.”
And they might have to cope with side effects.
The drugs can trigger liver and muscle damage, pain, stomach upset and diarrhea, loss of mental acuity and memory lapses. They may even boost the potential for diabetes – which triples chances of getting heart disease – in women who have gone through menopause (and presumably no longer have the heart-protective benefits of estrogen). While for most people these irritants are relatively mild, the clinical tests where they were uncovered only lasted for five or seven years. “What kind of problems will crop up after 30 years?” wonders Ioannidis. “We don’t know. And remember, even in large clinical trials with 5,000 to 10,000 people, a side effect that only shows up in 1 percent of the population may not be picked up but could pose a real problem once millions of people are taking a drug.”
When Michael Robinson of Valleyford, Washington, was given a statin eight years ago after his cholesterol levels jumped, he experienced such debilitating pain that “I thought I was going to die,” he recalls. So the songwriter and musician, now 72, lost 30 pounds and started exercising and eating better, and brought his counts down without medication. But 20 pounds gradually crept back on, and he became more sedentary. When an ultrasound this past March revealed that his carotid artery was narrowed by about 70 percent, he got back on the program, eating right, exercising regularly – and taking 20 milligrams daily of Pravastatin. “I want to do everything possible to avoid a heart attack or stroke,” says Robinson, whose total cholesterol tumbled in just six weeks from 233 to 182.
The bottom line? Really quiz your doctor, says Stone. If a careful assessment of your risk level puts you in the gray area, lifestyle changes, still the best preventive medicine, may be enough of a first step, with statins reserved for when more steps are needed. That strategy has worked so well for Marquez, she says, that she is “totally blown away.” She’s brought both her LDL and total cholesterol counts down about 70 points, to 105 and 191, without medicine.