ISSUE1768
- Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
- Susan Daron, Pharm D., Associate Editor has disclosed no relevant financial relationships.
- Review recent evidence on the use of statins for primary prevention of atherosclerotic cardiovascular disease in older patients.
- A randomized, double-blind trial compared atorvastatin to placebo in healthy, independent adults ≥70 years old with a median follow-up of 5.9 years.
- Atorvastatin was associated with a 30% lower risk of a primary cardiovascular event (a composite of cardiovascular death, nonfatal myocardial infarction or stroke, or coronary revascularization). The reduction was driven mainly by a decrease in nonfatal cardiovascular events; atorvastatin did not reduce the risk of cardiovascular death.
- Atorvastatin was not associated with an increased or decreased risk of dementia or death from any cause.
- In relatively healthy older adults, starting a statin for primary prevention can reduce the risk of nonfatal cardiovascular events, but it does not appear to reduce the risk of cardiovascular death.
- Shared clinical decision-making is a reasonable approach when deciding whether to start statin therapy for primary prevention of atherosclerotic cardiovascular disease in older adults.
HMG-CoA reductase inhibitors (statins) are the drugs of choice for lowering low-density lipoprotein cholesterol (LDL-C).1 They reduce the risk of primary and secondary atherosclerotic cardiovascular disease (ASCVD) events and death, but data supporting their efficacy and safety in older adults have been lacking.2 Guidelines recommend weighing the potential risks and benefits when deciding whether to start or stop statin therapy for primary prevention in adults >75 years old.3 Results of a trial evaluating statin initiation for primary prevention of ASCVD in older persons have recently been published.
THE NEW TRIAL ― In a double-blind trial (STAREE), 9971 community-dwelling adults ≥70 years old without cardiovascular disease, diabetes, or dementia were randomized to receive atorvastatin 40 mg or placebo once daily. At baseline, the mean LDL-C level was 127 mg/dL. After a median follow-up of 5.9 years, treatment with atorvastatin had reduced mean LDL-C by 48 mg/dL (vs 16 mg/dL with placebo). Almost half of the patients discontinued atorvastatin within 5 years.
The primary cardiovascular endpoint (a composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization) occurred significantly less often with atorvastatin than with placebo (10.9 vs 15.5 events/1000 patient-years; hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.61-0.82). The number needed to treat (NNT) to prevent one cardiovascular event was 37. The reduction in the primary cardiovascular endpoint was driven mainly by a decrease in nonfatal events; there was no significant difference between atorvastatin and placebo in the rate of cardiovascular death. There was also no significant difference between the two groups in the rate of disability-free survival (a composite of death from any cause, dementia, or persistent physical disability), the other primary endpoint.4
SAFETY ― Musculoskeletal, hepatobiliary, and diabetes-related adverse events occurred more often with atorvastatin than with placebo in the STAREE trial.4
CONCLUSION ― In relatively healthy older adults, starting a statin for primary prevention appears to reduce the risk of nonfatal cardiovascular events, but not the risk of cardiovascular death. Shared clinical decision-making is a reasonable approach when deciding whether to start statin therapy for primary prevention of atherosclerotic cardiovascular disease in such patients.
- Drugs for hypercholesterolemia. Med Lett Drugs Ther 2026; 68:89.
- MB Mortensen. Statins in older adults – evidence at last. N Engl J Med 2026; 395:1327. doi:10.1056/nejme2611127
- RS Blumenthal et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of dyslipidemia: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2026; 153:e1194. doi:10.1161/cir.0000000000001423
- S Zoungas et al. Atorvastatin, cardiovascular events, and disability-free survival in older adults. N Engl J Med 2026; 395:1259. doi:10.1056/nejmoa2607314
