Ever since the FDA announced plans to place new warning labels on cholesterol-lowering statins last week due to complaints of memory loss and evidence of diabetes, it seems the phone lines of primary care physicians and cardiologists have lit up.
Mario Garcia, M.D., the chief of cardiology at Montefiore Medical Center and professor of medicine and of radiology at Einstein, says he’s received a slew of calls from anxious patients wondering if they should continue statin therapy.
Statins are effective for those with previous heart attacks or those who’ve had bypass surgery or angioplasty. “There’s no question that taking a statin after a cardiac event improves the odds of survival,” he says.
The real issue, he warns, is widespread prescription of statins in primary prevention for otherwise healthy people with few risk factors such as a family history of heart disease, high cholesterol, high blood pressure or diabetes.
Because one in three Americans will die of cardiac or vascular complications, Dr. Garcia says, doctors often cast the “statin net” far and wide, with more than 20 million prescriptions written in the United States last year. Yet despite diagnostic and treatment advances, as many as 50 percent of heart attacks occur without warning—in those without known risk factors.
“We are treating a larger pool of patients who probably don’t need statin therapy because we don’t know which patients will go on to develop heart disease, but we’re probably not treating enough patients who will have cardiac events because they don’t have traditional risk factors.
“It does trouble me,” he concedes, “because, in many cases, we’re guessing.” In the face of so much uncertainty, what’s a patient to do?
Dr. Garcia, who is also co-director of the Montefiore-Einstein Center for Heart and Vascular Care, believes that most patients taking statins for prevention will fare well with lower doses to achieve a desirable result. He also recommends that patients with risk factors but without diagnosed heart disease undergo CT scans to detect the level of calcium buildup in their arteries.
The painless test, which costs between $100 and $400, emits about the same level of radiation as a mammogram. While not generally covered by insurance, it can take some of the guesswork out of which patients will develop a cardiac event. “If you have a 60-year-old man with a calcium score of 1 [on a scale of 0 to 1,000, lower is better], you could make a strong argument against using statins even if the patient has high cholesterol or high blood pressure,” Dr. Garcia says. A baseline test, he suggests, followed by periodic testing every three to five years, can give doctors a window into whether cardiac disease is progressing.
“They’re not perfect or suitable for everyone,” he says of the scans, “but the fact that they’re not covered by most insurance companies is unfortunate, and hopefully will change.
“If you look at the cost to society, the cost of a calcium-score test is nothing compared to the cost of statins over five years,” he adds. In fact, many patients remain on statins for decades, depending on their perceived risk profile.
Dr. Garcia says more research is urgently needed to better identify patients at risk. “We need genetic testing to determine which factors lead to heart disease. Until then, we’re forced to treat patients who are never going to develop heart disease.” Another concern is whether statins cause diabetes. Dr. Garcia says the issue there is that many patients regard statins as a “magic pill” that absolves them of the need to eat healthier and exercise.
“If someone is obese and has high cholesterol, the statin may provide a false sense of security.”
As noted in a recent study in Archives of Internal Medicine, all drugs carry risks—even aspirin, which is now no longer recommended for those without heart disease due to the danger of bleeding. Dr. Garcia stresses that when it comes to statins, doctors and patients need to weigh choices carefully.
“In patients who have a side effect of any kind, you have to question risk over benefit.”