While there is evidence to support older adults taking statins for secondary prevention of cardiovascular disease – such as to prevent a second heart attack or stroke – there is limited evidence on the risks and benefits of this age group taking the cholesterol-lowering medication to prevent a first cardiovascular event. Now, an analysis of data from a clinical trial that compares it with usual care finds no benefit in use of a statin for primary prevention in older adults with high blood pressure and moderately high cholesterol.
Benjamin H. Han, an assistant professor in the Department of Medicine at New York University School of Medicine, NY, and colleagues report their findings in the journal JAMA Internal Medicine.
While the body needs some cholesterol, if levels in the blood are too high, they can promote the buildup of plaque in artery walls, raising the risk of heart disease and stroke.
Statins work by lowering the liver’s production of cholesterol and helping it to remove cholesterol from the bloodstream.
In 2016, the United States Preventive Services Task Force (USPSTF) issued new guidelines for the use of statins in primary prevention of cardiovascular disease (such as to prevent a first heart attack or stroke).
The USPSTF say that the guidelines do not include recommendations for adults over the age of 75 because there is insufficient evidence for this age group.
Prof. Han and colleagues note in their study paper that despite this lack of evidence, “many older patients take statins for primary cardiovascular prevention,” and that such use is on the rise.
They refer to a survey on medical expenditure in the U.S. that finds statin use for primary cardiovascular prevention among people older than 79 years has risen more than threefold between 1990-2000 and 2011-2012 (from 8.8 percent to 34.1 percent, respectively).
Thus, in the new study, Prof. Han and colleagues set out to answer the question: “Are statins beneficial when used for primary cardiovascular prevention in older adults?”
To answer the question, they analyzed data on a subgroup of older adults who took part in a randomized clinical trial called the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial – Lipid-Lowering Trial (ALLHAT-LLT), which ran from 1994 to 2002.
The researchers analyzed results on a subgroup of 2,867 participants aged 65 and older with high blood pressure and no evidence of plaque buildup in their arteries (a hallmark of atherosclerotic cardiovascular disease) at baseline.
The study participants were randomly assigned to receive one of two cholesterol-lowering treatments. Of these, 1,467 were assigned 40 milligrams per day of pravastatin sodium treatment, and the other 1,400 were assigned the usual care from their doctors.
The analysis found no significant differences between the two groups in three types of result: deaths due to all causes, deaths to specific causes, and coronary heart disease (CHD) events.
Among participants aged 65 to 74, there were more deaths in the pravastatin group (141) than in the usual care group (130). This was also the case in those aged 75 and older (92 and 65 deaths, respectively).
Looking at the CHD results, the analysis for participants aged 65 to 74 showed that there were 76 CHD events in the pravastatin group and 89 in the usual care group. For those aged 75 and older, these figures were 31 and 39, respectively.
The authors conclude, “No benefit was found when a statin was given for primary prevention to older adults. Treatment recommendations should be individualized for this population.”
In an accompanying editor’s note, Dr. Gregory Curfman, editor in chief of Harvard Health Publications at Harvard Medical School in Boston, MA, highlights the risks that can be associated with statin use. These include “musculoskeletal disorders, including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies.”
He notes that such side effects may cause particular problems and promote frailty and disability in older adults. Statin use has also been linked to memory and thinking problems, which could further compromise older people’s ability to function in daily life. He suggests, therefore, that:
“The combination of these multiple risks and the ALLHAT-LLT data showing that statin therapy in older adults may be associated with an increased mortality rate should be considered before prescribing or continuing statins for patients in this age category.”