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Key clinical point: Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes.
Major finding: For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care (HR, 1.08), and for those aged 75 years and older, there were 92 deaths with pravastatin vs. 65 with usual care (HR, 1.34).
Data source: A secondary analysis of data in the randomized, open-label ALLHAT trial, focusing on 2,867 elderly participants followed for 6 years.
Disclosures: This work was supported by the National Institutes of Health. Pfizer, AstraZeneca, and Bristol-Myers Squibb provided study medications free of charge. Dr. Han and his associates reported having no relevant financial disclosures.
Statins are commonly prescribed for primary prevention to older patients, particularly those older than age 75 years. And the prevalence of use in this patient population is increasing.
But statins are associated with a variety of musculoskeletal disorders – including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies – which may be particularly harmful in older people and contribute to their physical deconditioning and frailty. The drugs also have been linked to cognitive dysfunction, which can further raise the risk of falls and disability.
Physicians should take into consideration these multiple risks, in addition to the ALLHAT data showing no mortality benefit in this age group, before prescribing or continuing statin therapy in such patients.
, is at Harvard Medical School, Boston, and is also the health care policy and law editor for JAMA Internal Medicine. Dr. Curfman reported having no relevant financial disclosures. He made these remarks in an Editor’s Note accompanying Dr. Han’s report.
Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.
Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said, of the division of geriatric medicine and palliative care, New York University, and his associates.
The primary outcome, all-cause mortality, was slightly higher in the statin group. For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care, for a hazard ratio of 1.08, and for those aged 75 and older, there were 92 deaths with pravastatin vs. 65 with usual care, for an HR of 1.34. This represents a nonsignificant trend toward increased mortality with statin therapy. The results were similar, with pravastatin providing no significant benefit, regarding coronary heart disease, stroke, heart failure, and cancer events.
These findings indicate that “statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit,” Dr. Han and his associates said (JAMA Intern Med. 2017 May 22.).
One important limitation of this secondary analysis is that patients were allowed to cross over to the other study group during follow-up, at their own or their physicians’ discretion. By the end of the study, 29% of the control group were taking lipid-lowering drugs while 22% of the active-treatment group had discontinued pravastatin. “This level of crossover should be considered when interpreting our findings,” the investigators noted.
October 11, 2017
December 14, 2016