Use of statins in the primary prevention setting yields a substantial reduction in the risk of major cardiovascular events in community-dwelling adults at least 70 years of age, as shown in the STAREE trial.
In a cohort of ≥70-year-old participants with no history of cardiovascular disease, diabetes, or dementia who were followed for a median of 5.9 years, daily treatment with atorvastatin 40 mg was associated with a 30-percent reduction in the risk of a first major cardiovascular event—defined as a composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization—compared with placebo (10.9 vs 15.5 events per 1,000 person-years, hazard ratio [HR], 0.70, 95 percent confidence interval [CI], 0.61–0.82; p<0.001). [N Engl J Med 2026;doi:10.1056/NEJMoa2607314]
However, the beneficial effect of atorvastatin on major cardiovascular events did not translate to gains in disability-free survival. The risk of combined death from any cause, dementia, or persistent physical disability was similar between the atorvastatin and placebo groups (21.6 vs 23 events per 1,000 person-years, respectively; HR, 0.94, 95 percent CI, 0.84–1.05; p=0.25).
Lead author Prof Sophia Zoungas from Monash University in Melbourne, Victoria, Australia, noted that the reduction in the risks of the secondary cardiovascular outcomes—a composite of cardiovascular death, myocardial infarction (MI), or stroke, fatal and nonfatal MI, fatal and nonfatal stroke, coronary revascularization, and all arterial revascularizations—were consistent with the overall treatment effect.
“STAREE is the first large-scale trial of atorvastatin for primary prevention to show cardiovascular benefit in people aged 70 years and older,” Zoungas said.
“The risk of heart attack and stroke is a concern for older people, and knowing there is an effective measure for lowering that risk will be a huge reassurance to older people and their families,” she added.
STAREE trial
STAREE included 9,971 participants (mean age 74.7 years, 51.9 percent female, 98.3 percent White), enrolled from general practices across Australia. These participants were randomly assigned to receive atorvastatin at a dose of 40 mg once daily (4,984) or identical placebo (n=4,987).
At baseline, most participants reported current alcohol use and no history of smoking. The median BMI was 27 kg/m2, and the mean blood pressure was 136/80 mm Hg. The median number of concurrent medications was two, with 19.6 percent of participants taking at least five medications, including antihypertensive agents (46.3 percent), acid suppressants (27.1 percent), and analgesic agents (20.6 percent).
Muscle symptoms were common (46.1 percent), but memory symptoms were not (4.8 percent). The median cognitive score was 95 for those who completed the Modified Mini–Mental State examination (score range 0–100) in person and 70 for those who completed the examination by telephone (score range 0–73), with higher scores indicating better cognitive functioning. Most participants (88.7 percent) reported having no difficulty with bathing, dressing, toileting, transferring, walking across a small room, and feeding.
“Mean LDL cholesterol levels were in the normal range (upper limit, <135 mg/dL) at baseline and, as anticipated, were reduced by a mean of 47.6 mg/dL in the atorvastatin group as compared with 16.2 mg/dL in the placebo group (between-group difference, 31.4 mg/dL),” Zoungas noted.
The percentage of participants who had serious adverse events (AEs) were similar in the atorvastatin and placebo groups, both at 2.7 percent. However, the atorvastatin group had slightly higher rates of medically important AEs related to musculoskeletal or connective tissue disorders (1.1 percent vs 0.9 percent), hepatobiliary disorders (1.4 percent vs 0.3 percent), and diabetes and related disorders (1.1 percent vs 0.7 percent).
Most statin discontinuations in the trial were attributed to “participant unwilling” (15.6 percent in the atorvastatin group and 16.2 percent in the placebo group), with only a few attributed to AEs (7.2 percent and 6.1 percent, respectively).
Practice-changing
Study discussant Prof François Mach from the Geneva University Hospital, Geneva, Switzerland, congratulated Zoungas and colleagues for addressing an evidence gap concerning the prescription of statins for primary prevention in community-dwelling adults 70 years of age or older.
Despite the lack of effect of statins on disability-free survival, STAREE demonstrates that “age should no longer be used as a reason to withhold statin therapy for primary prevention. National and international lipid guidelines will have to be adapted accordingly,” Mach said.
It does not mean, however, that every ≥70-year-old individual should automatically receive statin treatment, Mach warned. “Treatment decisions should factor in life expectancy, competing risks, treatment burden, and patient priorities,” he said.
Clinicians should be asking which older adults they should treat, for how long, and whether preventing a cardiovascular event would give older adults a more meaningful life, Mach concluded.