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Statins yielded no benefit for primary cardiovascular prevention in older adults

Among patients aged 65 years and older, there was no difference in all-cause mortality or cardiovascular outcomes between pravastatin and usual care for primary cardiovascular prevention, indicating that recommendations for treatment should be individualized for this population, according to research published in JAMA Internal Medicine.

“While there is some evidence of benefit to secondary prevention with statins among older adults, data are limited on the risks and benefits of statins for primary prevention in this age group,” Benjamin H. Han, MD, MPH, from the division of geriatric medicine and palliative care at the New York University School of Medicine, and colleagues wrote. “Improving our understanding of preventive interventions in patients 75 years and older has many implications for health care and its costs.”

Han and colleagues used data from the Lipid-Lowering Trial component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) to analyze the effect of statin treatment when used for primary cardiovascular treatment in adults aged 65 years and older with hypertension and without baseline atherosclerotic CVD (n = 2,867). The trial was conducted between February 1994 and March 2002 at 513 clinical sites. The researchers assessed primary and secondary outcomes including all-cause mortality, cause-specific mortality and nonfatal myocardial infarction or fatal coronary heart disease combined. Participants were assigned to receive 40 mg of pravastatin per day (n = 1,467; mean age, 71.3 years; 48% female) or usual care (n = 1,400; mean age, 71.2 years; 50.8% female).

Data showed that the baseline mean LDL cholesterol levels were 147.7 mg/dL and 147.6 mg/dL in the pravastatin group and usual care group, respectively. These levels declined by year 6 to 109.1 mg/dL in the pravastatin group and 128.8 mg/dL in the usual care group. At year 6, 16.6% of participants receiving pravastatin and 71% of participants receiving usual care were not taking any statin. In the pravastatin group vs. usual care group, the hazard ratios for all-cause mortality were 1.18 (95% CI, 0.97-1.42; P = .09) for all adults 65 years and older; 1.08 (95% CI, 0.85-1.37; P = .55) for adults aged 65 to 74 years; and 1.34 (95% CI, 0.98-1.84; P = .07) for adults 75 years and older. Coronary heart disease event rates did not significantly differ between groups. These nonsignificant results remained even after multivariable regression analysis.

“Our study found that newly administered statin use for primary prevention had no benefit on all-cause mortality or [coronary heart disease] events compared with [usual care] in the subset of adults 65 years and older with hypertension and moderate hypercholesterolemia in the ALLHAT-LLT,” Han and colleagues concluded. “We noted a nonsignificant direction toward increased all-cause mortality with the use of pravastatin in the age group 75 years and older, but there was no significant interaction between treatment group and age. The use of statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit.” – by Alaina Tedesco

Disclosure: The researchers report receiving support from the National Heart, Lung and Blood Institute. Please see full study for complete list of relevant financial disclosures.