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"In February 2012, largely based on anecdotal reports, the U.S. Food and Drug Administration issued a safety statement warning patients of possible adverse mental effects associated with statin use," said senior study author Dr. Emil deGoma, medical director of the preventive cardiovascular program at the University of Pennsylvania's Perelman School of Medicine.
However, the scientific evidence the researchers analyzed showed that statins -- which include drugs such as Crestor, Lipitor and Zocor -- aren't connected with memory loss or mental declines, deGoma said.
Some of the studies they reviewed showed that people taking statins actually reduce their risk for dementia by 13 percent, their risk for Alzheimer's disease by 21 percent and their risk for other mental problems by 35 percent, deGoma said.
"I would not let concerns about adverse effects on mental functioning influence the decision to start a statin in patients suffering from cardiovascular disease or [those who are] at risk for cardiovascular disease," he said.
In addition, deGoma said, doctors should not assume statins are to blame when someone taking them becomes forgetful. "We may be doing more harm than good if we withhold or stop statins -- medications proven to reduce the risk of heart attack and stroke -- due to fears that statins might possibly cause memory loss," he said.
The report was published in the Nov. 19 issue of the journal Annals of Internal Medicine.
Dr. Gregg Fonarow, a spokesman for the American Heart Association, said statins are important in reducing the risk of heart attacks and strokes, and have been proven safe and effective numerous times.
"These findings should be highly reassuring to people taking -- or who should be taking -- statins to reduce their risk of cardiovascular events and stroke," said Fonarow, a professor of cardiology at the University of California, Los Angeles.
"As cardiovascular disease remains the leading cause of death, disability and health care expenditures, statin therapy, together with a healthy diet and regular exercise, represents one of the most extensively studied, safe, effective and value-driven ways to improve individual and population-level cardiovascular health," he said.
For the review, deGoma and his colleagues looked at 57 published studies that examined statin use and any connection with mental functioning, and they further analyzed 25 of them to see if a particular pattern emerged in the results.
They found no evidence that statins increased the risk for memory loss or thinking declines. Moreover, test scores on memory and other mental functions did not differ between statin users and nonusers.
The researchers also analyzed FDA data, and couldn't come up with any differences in mental decline among people using statins and people taking two drugs that have not been associated with mental decline. Those drugs are the blood pressure medication Cozaar (losartan) and the blood thinner Plavix (clopidogrel).
Despite the findings, deGoma wasn't ready to say the FDA should backtrack on its decision to issue a warning about a rare risk for memory loss while using statins.
"I think it's hard to say whether or not adding mental impairment to the statin safety label may have been premature," he said. "I am hoping that the FDA provides greater detail regarding the rationale for their decision. Once their data analysis is made public, I think we can have a better discussion about the labeling."
An FDA official said, however, that the new finding doesn't warrant eliminating or changing the current safety warning on statins.
That warning states only that there have been rare cases in which statin use may have been associated with memory loss that wasn't serious and was reversed once the patient stopped taking the drug, said FDA spokeswoman Morgan Liscinsky.
Since Alzheimer's disease and dementia are progressive diseases and not temporary conditions, "a finding that statins are not associated with a risk for dementia, Alzheimer's disease or any decline [in thinking ability] would not necessarily conflict with the current labeling of statins," Liscinsky said.
This latest review should be reassuring to the approximately 30 million people in the United States taking statins, deGoma said. "I do not think mental impairment should be a significant concern with statin use," he said.
At the same time, the researchers would like to see more randomized trials conducted to confirm their findings.
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