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From:
JAMA Internal Medicine
Was a Statin Beneficial for Primary Cardiovascular Prevention in Older Adults?
Analysis of data from older adults who participated in a clinical trial showed no benefit of a statin for all-cause mortality or coronary heart disease events when a statin was started for primary prevention in older adults with hypertension and moderately high cholesterol, according to a new article published by JAMA Internal Medicine.
Many older patients take statins for primary cardiovascular prevention but data are limited on the risks and benefits of statins for primary prevention in this age group. Improving the understanding of preventive interventions in older patients has implications for health care and its costs.
Benjamin H. Han, M.D., M.P.H., of the New York University School of Medicine, and coauthors analyzed data from older adults in the Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT), which was conducted from 1994 to 2002.
The authors used an analytical sample that included 2,867 adults with hypertension but without baseline atherosclerotic cardiovascular disease (plaque build-up in the arteries). Of the 2,867 adults, 1,467 were in the pravastatin sodium group (40 mg per day) and 1,400 received usual care from their primary care physician to lower cholesterol.
The authors report no benefit of pravastatin for the main outcome of all-cause mortality or secondary outcomes of coronary heart disease events and cause-specific mortality. More deaths occurred in the pravastatin group than in the usual care group (141 vs. 130) among adults 65 to 74 and among adults 75 and older (92 vs. 65). There were 76 CHD events in the pravastatin group compared with 89 in the usual care group among adults 65 to 74 and 31 CHD events compared with 39 among adults 75 and older, according to the results. Stroke, heart failure and cancer rates were similar in the two treatment groups for both age groups.
Authors note limitations of the current study, which include its design as a post hoc secondary analysis of a trial of a subgroup of patients.
“No benefit was found when a statin was given for primary prevention to older adults. Treatment recommendations should be individualized for this population,” the article concludes.
For more details and to read the full study, please visit the For The Media website.
(doi:10.1001/jamainternmed.2017.1442)
Editor’s Note: The article contains funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Expert Reaction
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
Professor Richard O'Brien is Clinical Dean of Medicine at the Austin Clinical School at the University of Melbourne. He is also Director of Lipid Services at the Austin Hospital.
"This paper has analyzed data from ALLHAT, an almost 20 year old study, to attempt to quantify the benefit of therapy with a statin (pravastatin) in elderly people with no previous history of vascular disease (no pervious heart attack, stroke or other disease of the blood vessels).
The analysis found no statistically significant difference between the pravastatin and placebo groups in any of the outcomes measured. There was a trend towards a decrease in heart attacks but also a slight trend towards an increase in mortality in those taking pravastatin.
The people in this analysis had no previous vascular disease: these results must not be extrapolated to people with previous heart attacks or strokes: there is a wealth of data from many studies that these people (including the elderly) derive great benefit from statin therapy.
The drug used was pravastatin, a weak and older statin not commonly used today.
The trial was open label – the doctors and patients knew what they were taking. This is a potential source of bias as doctors may treat their patients differently, perhaps not being as aggressive at treating other heart risk factors, if they know the person is taking a statin.
People in the trial could be treated with a statin if their doctor wished, and many were, including in the 'placebo' group. This led to a big dilution in the effect of the study treatment, so that the difference in LDL “bad cholesterol” was only 17%. This would be considered very inadequate today: guidelines suggest that effective statin therapy should achieve a minimum LDL reduction of 30%.
A small difference in LDL cholesterol means the expected reduction in heart attacks and deaths from heart attack will be small. Under these circumstances, it only takes a few excess deaths from other causes in the treatment group (and of course deaths are common in an elderly population) to confound the results and make it appear as if the drug has caused harm.
Studies with newer statins have demonstrated substantial reductions in heart attack and stroke in elderly people without cardiovascular disease, but not reductions in mortality.
Preventing a non-fatal heart attack or stroke in an elderly person may dramatically improve potential quality of life, even if it does not prolong life. Statins have been shown to achieve this.
An accompanying editorial by Gregory Curfman suggests that these findings may be of concern and cites other potential problems with statins including multiple musculoskeletal problems and memory disturbance.
This is incorrect. The paper he cites on musculoskeletal problems has been criticized in the literature for its methodology, and I am unsure why he believes there are problems with cognitive function (he includes no reference). Large studies using statins and other cholesterol lowering agents, treating patients to very low cholesterol levels, have been totally reassuring in this respect.
A more responsible conclusion from this study is that statin therapy in older people without previous heart disease is unlikely to prolong life, but may reduce heart attack and stroke risk. Therefore, whether or not to take a statin may depend on a patient’s individual philosophy, and should be a choice a person takes after discussion with their doctor."
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