Statins are increasingly prescribed to older adults to stave off premature death from heart disease, despite a lack of evidence that this practice benefits older populations. Now, a study published online May 22 in JAMA Internal Medicine finds that the cholesterol-lowering drugs may not extend lifespan in heart-healthy older adults.
A team led by researchers at NYU Langone Medical Center reviewed data from 2,867 adults who participated in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT), which concluded in 2002. They found no significant differences in all-cause mortality or cardiovascular outcomes between groups randomized to receive either statins or usual care.
Recently published guidelines from the United States Preventive Services Task Force highlighted the lack of evidence supporting statin use for primary cardiovascular prevention in older adults, particularly for those older than 75, something the researchers sought to address with the new study.
“As the number of older adults in the United States is rapidly increasing, it is more important than ever that we improve our understanding of preventative interventions in aging patients, and the possible side effects and risks that accompany them,” says lead author Benjamin Han, MD, MPH, an assistant professor in NYU Langone’s Department of Medicine’s Division of Geriatric Medicine and Palliative Care, and Department of Population Health. “Our study argues that the benefits of initiating statins in older patients, particularly those over 75, may not outweigh the risks.”
Researchers limited their sample to participants 65 years and older with hypertension and without evidence of atherosclerotic cardiovascular disease. Half were treated with pravastatin and half received usual care, to measure pravastatin’s effect on all-cause mortality, with a secondary interest in cardiovascular outcomes such as coronary heart disease and nonfatal heart attacks.
The researchers noted a nonsignificant direction toward increased mortality in adults aged 75 years and older who received pravastatin. David G. Sutin, MD, study co-author and clinical associate professor in the Department of Medicine’s Division of Geriatric Medicine and Palliative Care, says the findings could be explained by side effects of statin use.
“We know that any negative effect on day-to-day function places older adults at higher risk for functional decline and death,” says Dr. Sutin. “It’s possible that, for these more vulnerable older adults, the muscle pain or fatigue that can come with statins offset the benefit of statins for primary cardiovascular prevention.”
Dr. Han says clinicians need to consider not just cardiovascular results, but also the patient’s chronic medical conditions, medications, and everyday function, as they weigh the potential benefits and risk of statin use. “Providers should engage in shared decision-making with their older patients and treatment recommendations should be individualized,” he says.
The study authors are joining others in the field in a call for more studies that focus on primary cardiovascular prevention in older adults.
In addition to Dr. Han and Dr. Sutin, other researchers involved in this study were Caroline S. Blaum, MD, the Diane and Arthur Belfer Professor of Geriatric Medicine, director of the Division of Geriatrics and Palliative Care, and professor in the Department of Population Health at NYU Langone; Jeff Williamson from Wake Forest School of Medicine; and Barry Davis, Linda Piller, Hannah Pervin, and Sara Pressel from the Coordinating Center for Clinical Trials at University of Texas School of Public Health.
This study was supported by contracts NO1-HC-35130 and HHSN268201100036C with the National Heart, Lung, and Blood Institute. The ALLHAT investigators acknowledge study medications contributed by Pfizer Inc., AstraZeneca, and Bristol-Myers Squibb and financial support provided by Pfizer Inc. Dr. Han is supported by New York University Clinical and Translational Science Award grant KL2 TR001446 from the National Center for Advancing Translational Sciences. Dr. Sutin and Dr. Blaum are partially supported by The Stroke Foundation, Inc., of Sarasota, Florida.