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Controversy Over Statins for Older Patients/New AHA Guidelines
  NY Times blog
October 22, 2013, 3:26 pm
Should older adults take statins if they have elevated cholesterol but no evidence of heart disease? It's a surprisingly controversial question, given the number of seniors taking statins.
Recently AMDA, a professional group representing physicians working in nursing homes, highlighted the issue in a list of five questionable medical tests and treatments. The list was drawn up as part of the national "Choosing Wisely" campaign, which alerts consumers to inappropriate or overused medical interventions, an effort that caregivers would do well to follow.
The standout item on the AMDA list: "Don't routinely prescribe lipid-lowering medications in individuals with a limited life expectancy." That means anyone older than 70, according to the medical society.
Dr. Hosam Kamel, an Arkansas geriatrician who is vice chair of AMDA's clinical practice committee, said that there is scarce scientific evidence supporting the use of statins by 70- or 80-year-olds without pre-existing cardiovascular disease. Only a handful of studies have focused on outcomes (heart attacks, strokes, premature death) in this older population.
Most of the data on the benefits of statin use come from larger studies that looked at adults of varying ages. The results don't conclusively establish the benefits of using statins for seniors with healthy hearts, Dr. Kamel said. There is evidence of harm linked to statin use in seniors, he added, including muscle aches, liver toxicity and gastrointestinal distress; growing evidence of impaired memory and a heightened risk of diabetes; and some evidence of an increased risk of cancer.
(The Food and Drug Administration required drug companies to note the risks of memory loss and diabetes, along with other possible complications, on statin labels for the first time in 2012.)
"Our recommendation is that physicians weigh the potential risks and benefits and not automatically prescribe these medications," Dr. Kamel said. That advice applies only to seniors who haven't been diagnosed with cardiovascular disease. A significant body of evidence does support the benefits of statins in older adults who have already had a heart attack or stroke.
Several leading cardiologists support AMDA's emphasis on individualized decision-making, but take issue with this assessment of statins' efficacy in older adults.
"The evidence is weaker for older patients - practically none at that age - but it is not unreasonable to expect similar effects as in younger patients," Dr. Harlan Krumholz, a cardiologist at Yale School of Medicine, said in an e-mail. "I believe that this is a decision that ought to be personalized for each individual," Dr. Krumholz added. "What are their risks? What do they value? What is the presumed benefit?"
Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, recalled an 80-year-old patient with high blood pressure, high cholesterol, elevated levels of C-reactive protein (a marker for inflammation) - but no known history of heart disease. After calculating that the man's risk of having a heart attack in the next 10 years was 30 percent, Dr. Nissen prescribed statins. Today the man is still alive at the age of 97 and doing well in assisted living, Dr. Nissen said.
"I don't think it's about age. It's about the person's life expectancy and the likelihood of achieving a true benefit with this therapy," Dr. Nissen said. "The message here has to be that if you're dying of some other disease - say, cancer or kidney failure - there isn't much benefit in giving a statin. But if you're a healthy 80-year-old with a Framingham Risk Score of 20 percent or greater, then I would tend to treat."
(You can calculate your own Framingham Risk Score, which assesses your 10-year risk of a heart attack, here. )
Dr. William Zoghbi, immediate past president of the American College of Cardiology, advised seniors with high cholesterol to first try changing their diets and getting more exercise. If these fail to lower cholesterol levels, he said, then statins are a reasonable option.
"Recent data has shown that shown that in older adults, primary prevention for people who have high cholesterol but no overt evidence of cardiovascular disease is beneficial," said Dr. Zoghbi, director of the Cardiovascular Imaging Institute at the Methodist Hospital in Houston.
He was referring to a recent paper in The Journal of the American College of Cardiology about statins and older adults. It is an analysis of eight randomized trials involving nearly 25,000 people aged 65 or older that analyzed outcomes for seniors without pre-existing heart disease who took these medications. Seniors who took the medications had fewer heart attacks (a 39.4 percent reduction) and strokes (a 23.8 percent reduction) than those who did not, but they didn't live longer.
Yet the absolute risk of these events was small. In the control group, 3.9 percent of seniors suffered heart attacks over the course of three-and-a-half years; that declined to 2.7 percent in the group taking statins. Similarly, 2.8 percent of seniors in the control group suffered strokes, compared with 2.1 percent of statin users.
"Taking statins may not prolong life in older adults, but it may certainly improve the quality of life" for people who might otherwise become disabled by heart attacks of strokes, said Dr. Antonio Gotto Jr., one of the authors of the analysis and dean emeritus of Weill Cornell Medical College.
As in many studies of this kind, the incidence of side effects associated with statin use was not reported. "This data is very well guarded," and without it the clinical picture is incomplete, said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, Medical Center and editor-in-chief of JAMA Internal Medicine.
"I see elderly patients every week who tell me they couldn't get out of bed, they had terrible diarrhea, they were walking around in a fog after they started taking statins, and when they stopped the medications those feelings went away," Dr. Redberg said.
According to her summary of the evidence for using statins to prevent heart disease, heart attacks will be prevented in only one or two of every 100 healthy people with high cholesterol who take the medications for up to five years, while one person will develop diabetes. Meanwhile, it is worth noting that "older people are much more vulnerable to the side effects of medications," she said, and there's some evidence that "low cholesterol seems to be associated with higher mortality at an older age."
Experts agree that more high quality evidence is needed about statin use in seniors without existing heart disease. Pending that, it seems this debate isn't going to be resolved any time soon. As ever, consult with a doctor before starting or discontinuing any medication.
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