When the guidelines for taking statins were changed last year, it made lots of noise. The revision for the drugs, which are prescribed to control blood cholesterol and prevent heart disease, classified millions more people as candidates for daily use. The new recommendation, by the American Heart Association and the American College of Cardiology, ignored lifestyle changes that should be tried before drugs, which can always have side effects.
Now, a new study invites concern that among the potential side effects of statins, which include the well-known Lipitor, Crestor and Zocor, is a heightened risk of severe muscle pain and impaired thinking among older people.
The study was published last month in the Annals of Internal Medicine. The researchers expressed concern that the benefits of taking statins do not outweigh the risks for this group of patients.
The study involved data from the National Health and Nutrition Examination Survey for adults 75 and older. If all of the study subjects took statins, it would add 8 million users, and would prevent 105,000 heart attacks and 68,000 deaths. But a significant number of the new users would suffer muscle weakness and cognitive impairment.
“An increased relative risk for functional limitation or mild cognitive impairment … could offset the cardiovascular benefits,” the researchers wrote. “At effectiveness similar to that in trials, statins are projected to be cost-effective for primary prevention, however, even a small increase in geriatric-specific adverse effects could offset the cardiovascular benefit. Improved data on the potential benefits and harms of statins are needed to inform decision making.”
As Patrick wrote in his December patient safety newsletter, “Spotlight on Statins,” statins are of concern for every age group because of their association with an increased risk of diabetes. This is particularly poignant for a drug that is supposed to address the risk of cardiovascular problems – diabetes is a risk factor for heart problems. The longer someone takes statins, it appears, the greater the risk of developing diabetes.
As reported on AboutLawsuits.com, users of high potency statins, such as Lipitor, Crestor and Zocor, might face as much as a 15% higher risk of being diagnosed with diabetes within two years of starting treatment. In other words, for every 350 patients taking a high potency instead of low potency statin, one would contract diabetes.
In 2012, the FDA required the makers of higher potency statins to include label warnings about the potential impact of the medication on blood glucose levels. But a lot of people believe the warnings aren’t strong enough. They might be right – Pfizer and AstraZeneca are facing multiple lawsuits over Lipitor and Crestor, respectively, about their lack of sufficient diabetes warnings by statin users who contracted the disease.
Statins are hugely profitable drugs, generating sales of more than $14.5 billion per year. They work by blocking the body’s ability to make of cholesterol, which is a key contributor to coronary artery disease. In addition to the diabetes risk, other problems have been associated with statin use, including muscle damage and kidney problems. And now, especially among older people, cognitive troubles.
Of course, heart disease is life-threatening, and everyone must take it seriously. But if gentler interventions haven’t been tried before those with clear risks, the approach to treatment should be scrutinized.
For more information about other dangerous drugs, see our backgrounder.