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 Statins Pose Marginal Benefit For Older Seniors

Older adults over 75 years with no comorbid conditions should consider taking statins to stave off heart disease, but only if no adverse effects result, says a new study in the Annals of Internal Medicine.
Two decades ago, statins, a cholesterol-lowering drug family that includes Lipitor, Crestor, and Zocor, once shone brightly as the antidote for heart disease. In 2003, these drugs became the most widely prescribed drugs of all time. Today they still remain a billion-dollar product.
However, a cloud recently has lowered on statins as studies have shown side effects ranging from the relatively mild—muscle and joint aches, headaches, and nausea—to the more extreme—muscle atrophy, diminished cognitive ability, diabetes, and liver disease.
Guidelines that came out in 2013 from the American College of Cardiology and the American Heart Association focus on four main groups of people who may be helped by statins: people who already have cardiovascular disease, people who have very high LDL (bad) cholesterol, people who have diabetes, and people who have a higher 10-year risk of heart attack. The guidelines are only intended for individuals aged 21 to 75 years, much to the worry of geriatricians.
Clinical trials rarely include individuals older than 75 years, one concern being that this part of the population is more frail and prone to cognitive impairments, the latter of which call into question informed consent or whether these individuals would be able to follow experimental protocol.
“There is a mix of logistical and ethical considerations,” says Michelle Odden, lead study author and epidemiologist at Oregon State University in Corvallis. “I believe it is something we need to overcome with thoughtful study design and the inclusion of diverse populations.”
The U.S. threshold of cost-effectiveness is typically $50,000 a year to prevent a death. Statins and their generics have become affordable to the public, averaging about $5-6 a month.
But seniors shouldn’t reach for the prescription bottle just yet, warns Odden. When the team factored in the adverse effects of cognitive and muscle impairments, it offset the aforementioned benefits. 
“Statins should be considered on a patient-by-patient basis,” says Michael Rich, a cardiologist from Washington University School of Medicine in St. Louis, who wrote an accompanying editorial.
Several factors should be taken into consideration, Rich says in his editorial. For instance, higher cholesterol has been associated with increased survival in adults over 85 years of age. Older patients may also be at increased risk of the drugs’ more serious adverse effects. Finally, older patients often have comorbid conditions that compete with heart disease as the cause of death—drugs taken to offset these other conditions may interact and alter the effectiveness of statins.
Rich says a push has gotten underway to get industry and FDA officials to include older patients in clinical studies, especially when there are drugs being developed for them. Nursing home and assisted living patients are rarely considered as participants, yet these individuals are often treated with statins and other drugs, he says.
Jackie Oberst is Provider’s managing editor. Email her at joberst@providermagazine.com or follow her on Twitter, @ProviderMag.
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