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.
Mario Garcia, M.D.
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.”
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I took Simvastatin for just three weeks two years ago. I developed excruciating pain in muscles and joints and stopped taking the medication. The pain went away, but my muscles continued to deteriorate. It took 18 months, and many different doctors, before Dr. Ralph at UC Med Center in San Francisco had eliminated all other possible causes; he did a biopsy to eliminate genetic causes. The cause of my problem was statin. My CPK count was over 1,000 and two muscles in my calves are completely gone. The mitrocondrial-level inflammation can be treated with Pednisone and CellCept, but, that only protects me from further muscle damage. While the FDA addresses “muscle weakness” they still do not seriously address the danger that Statins can disable people who are prescribed it as a prophelactic. The problem is being swept under the rug in exchange for corporate profits. My condition is not as rare as they would have us believe.
Thanks for reading the post and for your comment, Noreen.
I was interested in the comments of Dr. Mario Garcia on the over use of statins. Of course he is correct that many patients are being treated who will not derive benefit. However, there is excellent evidence that the use of statins as primary prevention in certain populations has reduced the occurrence of subsequent cardiac events. Dr. Garcia is careful to include patients with risk factors and those with previous cardiovascular events in those in whom statins should be prescribed. In these groups numerous studies have demonstrated the life preserving value of statins. It is in the 50% of asymptomatic persons who do not have these traditional risk factors, yet who eventually die from cardiovascular disease, in whom we should be identifying early subclinical disease and who almost certainly should be treated.
Dr. Garcia recommends screening with a calcium-score test. There is little doubt that a high score would be and indication for statin and other preventive therapies, such as life style and dietary modification. A low calcium-score in the vast majority of cases will provide assurance that the patient’s risk from atherosclerotic disease is low. However, my hope is that we can find methods to identify younger subjects who are destined to eventually develop atherosclerotic and radiological visible coronary calcium, well before these events occur. Genetic testing may provide a statistical probability approach, but I question whether it will have a high degree of specificity in an individual patient.
Dr. Garcia’s advice, based upon our current knowlege is excellent. However, we must strive to do get better tools for the early detection of cardiovascular risk. Dr. Jay N. Cohn, who recently presented medical grand rounds, takes a multitest approach that in an individual subject might identify vascular abnormalities very early in their course, perhaps well before calcium deposits are visible. His approach deals with an individual and does not depend on the usual statistical probability of the various risk factor models. Dr. Cohn’s work must be considered preliminary, and perhaps hypothesis generating. However, the concept of very early detection of vascular abnormalities based upon measurements made in the individual, rather than depending upon probabilities based upon epidemiological risk factors to decide on therapy, has an intellectual appeal that should be rigorously tested.
James Scheuer, MD
Distinguished Professor of Medicine Emeritus
Uinversity Chairman of Medicine Emeritus
The Albert Einstein College of Medicine