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Statins in the very old

Drug-class library

Statins in the very old sit at the intersection of three separate questions that are usually collapsed into one: does the drug work in this age group, how long does it take to work, and what does it cost the person taking it.

Before you read on

Never stop or change a prescribed medication without speaking to your own prescriber. Several of the classes described on this site rebound, or cause a withdrawal syndrome, when they are stopped abruptly, and some have to be reduced gradually over weeks or months under supervision. Nothing here is advice about your own medication, and nothing here is a reason to change anything on your own.

Do they work in older adults?

Yes, and the evidence is randomized. An individual-participant-data meta-analysis of 28 randomized controlled trials found a 21% proportional reduction in major vascular events per 1.0 mmol/L reduction in LDL cholesterol — relative risk 0.79 (95% CI 0.77 to 0.81) — with a significant reduction in all age groups. Stroke of any type showed a relative risk of 0.84 with no significant difference by age.

But read the population before applying it. Only 14,483 of 186,854 participants across those 28 trials — 8% — were older than 75 at randomization. That single sentence, from the analysis itself, is the citable fact about how thin the evidence is at the ages that matter most here.

Where the evidence gets thinner, specifically

The trend toward smaller proportional reductions with age was not statistically significant for major vascular events overall (p = 0.06), and was significant for major coronary events (p = 0.009). The most important subgroup finding: the proportional reduction was similar irrespective of age among patients with pre-existing vascular disease (p = 0.2), but “appeared smaller among older than among younger individuals not known to have vascular disease” (p = 0.05).

The authors’ own conclusion states it plainly: “there is less direct evidence of benefit among patients older than 75 years who do not already have evidence of occlusive vascular disease. This limitation is now being addressed by further trials.”

The US Preventive Services Task Force reaches the same place in plainer language. For adults aged 76 and over it issues an I statement: “the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality.” Note the verb. That is a statement about starting, not about stopping, and it must not be read as a recommendation to discontinue anyone.

The trials that will answer this

Two large randomized trials are testing the over-75 primary-prevention question directly, and neither has reported.

  • STAREE randomized 9,971 community-dwelling adults aged 70 and over, living independently, without cardiovascular disease, dementia or diabetes, to atorvastatin 40 mg or placebo. Co-primary outcomes are disability-free survival and major cardiovascular events. Status: active, not recruiting. No results posted.
  • PREVENTABLE is recruiting toward 20,000 community-dwelling adults aged 75 and over without clinically evident cardiovascular disease, significant disability or dementia, testing atorvastatin 40 mg against placebo with new dementia and persistent disability as co-primary outcomes at four years. No results posted.

Nothing on this site attributes a finding to either trial, and anything claiming to report their results should be treated as an error.

How long does the benefit take?

A survival meta-analysis of eight randomized primary-prevention trials covering 65,383 adults, mean ages 55 to 69, found it takes 2.5 years (95% CI 1.7 to 3.4) to prevent one major adverse cardiovascular event per 100 patients treated; 1.3 years per 200 treated; 0.8 years per 500.

Two qualifications belong with those numbers every time. The analysis covers ages 50 to 75 — applying it to a 90-year-old is an extrapolation. And only one of the eight studies showed a decrease in all-cause mortality; the authors state: “There is no evidence of a mortality benefit.”

Time to benefit covers this reasoning in full.

The diabetes trade-off

This is documented, randomized, and on the FDA-approved label. Current statin labeling states: “Increases in HbA1c and fasting serum glucose levels have been reported with statins,” and instructs clinicians to inform patients that such increases may occur.

The 2010 collaborative meta-analysis of 13 randomized statin trials covering 91,140 participants, of whom 4,278 developed diabetes over a mean of four years, found an odds ratio of 1.09 (95% CI 1.02 to 1.17) with little heterogeneity — the origin of the “about 9%” figure. In absolute terms, treating 255 patients (95% CI 150 to 852) for four years produced one extra case of diabetes.

Relevant here specifically: that analysis found the risk of developing diabetes with statins “was highest in trials with older participants.”

A 2024 individual-participant-data meta-analysis of 19 randomized placebo-controlled trials covering 123,940 participants refined the picture and separated it by intensity:

  • Low- or moderate-intensity statin versus placebo: a 10% proportional increase in new-onset diabetes — relative risk 1.10 (95% CI 1.04 to 1.16).
  • High-intensity statin versus placebo: a 36% proportional increase — relative risk 1.36 (95% CI 1.25 to 1.48).
  • Where the new cases come from: approximately 62% of new diabetes diagnoses occurred in participants already in the top quarter of the baseline glycemic distribution. The underlying shift is very small — mean glucose up 0.04 mmol/L, mean HbA1c up 0.06% on low or moderate intensity and 0.08% on high intensity.

So the mechanism is a small upward shift in glucose that pushes people already close to the diagnostic threshold across it. The authors add the sentence that settles how to frame it: “any theoretical adverse effects of statins on cardiovascular risk that might arise from these small increases in glycaemia… are already accounted for in the overall reduction in cardiovascular risk that is seen with statin therapy in these trials.”

It is a real, labeled trade-off to weigh with a prescriber against an individual’s cardiovascular risk. It is not a reason for anyone to stop a statin on their own.

The label also records, under postmarketing experience, “rare reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with the use of all statins,” noting these were “generally nonserious, and reversible upon statin discontinuation.”

The one randomized discontinuation trial

381 adults with an estimated life expectancy between one month and one year, on a statin for at least three months, with recent functional deterioration and no recent active cardiovascular disease, mean age 74.1, were randomized to stop or continue. Death within 60 days occurred in 23.8% versus 20.3% (90% CI for the difference −3.5% to 10.5%, p = 0.36). The trial did not meet its noninferiority endpoint and should not be described as having proven noninferiority. Quality of life was better in the discontinuation group (7.11 versus 6.85, p = 0.04), and cardiovascular events were few in both arms.

The authors’ conclusion was that stopping “is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications,” and that “thoughtful patient-provider discussions regarding the uncertain benefit… are warranted.”

How often this comes up

Applying STOPPFrail to 464 applications for long-term nursing care found 274 eligible, median age 83, of whom 91.2% had at least one potentially inappropriate medication — and statins were the third most common category, present in 29.6%.

Common questions

Should a 90-year-old be on a statin?

It depends on whether they already have vascular disease, what their expected remaining life is, what else is on the list and what they want. The randomized evidence for benefit is much thinner in primary prevention above 75 — only 8% of participants across 28 trials were over 75 — and the USPSTF rates the evidence for initiating at 76 and over as insufficient. That is a reason for a conversation with the prescriber, not an answer. Time to benefit.

Do statins cause diabetes?

They produce a small dose-dependent upward shift in blood glucose that pushes people already close to the diagnostic threshold across it — a 10% proportional increase at low or moderate intensity and 36% at high intensity, in randomized trials, with about 62% of new cases occurring among those already in the top quarter of baseline glycemia. It is on the FDA-approved label. The same trials show the cardiovascular benefit already accounts for it. The medication review.

Back to the drug-class library.

References

  1. Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. The Lancet. 2019;393(10170):407–415. PMID 30712900 · DOI 10.1016/S0140-6736(18)31942-1.
  2. Mangione CM, Barry MJ, Nicholson WK, et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2022;328(8):746–753. PMID 35997723 · DOI 10.1001/jama.2022.13044.
  3. Monash University. A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE). ClinicalTrials.gov identifier NCT02099123. Active, not recruiting; no results posted. ClinicalTrials.gov. 2026. https://clinicaltrials.gov/study/NCT02099123.
  4. Duke University. PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE). ClinicalTrials.gov identifier NCT04262206. Recruiting; no results posted. ClinicalTrials.gov. 2026. https://clinicaltrials.gov/study/NCT04262206.
  5. Yourman LC, Cenzer IS, Boscardin WJ, et al. Evaluation of Time to Benefit of Statins for the Primary Prevention of Cardiovascular Events in Adults Aged 50 to 75 Years: A Meta-analysis. JAMA Internal Medicine. 2021;181(2):179–185. PMID 33196766 · DOI 10.1001/jamainternmed.2020.6084.
  6. Hansen MR, Hróbjartsson A, Pottegård A, et al. Postponement of Death by Statin Use: a Systematic Review and Meta-analysis of Randomized Clinical Trials. Journal of General Internal Medicine. 2019;34(8):1607–1614. PMID 31073857 · DOI 10.1007/s11606-019-05024-4.
  7. Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. The Lancet. 2010;375(9716):735–742. PMID 20167359 · DOI 10.1016/S0140-6736(09)61965-6.
  8. Cholesterol Treatment Trialists’ (CTT) Collaboration. Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis. The Lancet Diabetes & Endocrinology. 2024;12(5):306–319. PMID 38554713 · DOI 10.1016/S2213-8587(24)00040-8.
  9. Parke-Davis, Division of Pfizer Inc. LIPITOR (atorvastatin calcium) tablets — FDA-approved prescribing information. DailyMed, U.S. National Library of Medicine. 2026. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65.
  10. Kutner JS, Blatchford PJ, Taylor DH, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Internal Medicine. 2015;175(5):691–700. PMID 25798575 · DOI 10.1001/jamainternmed.2015.0289.
  11. Lavan AH, O’Mahony D, Gallagher P. STOPPFrail (Screening Tool of Older Persons’ Prescriptions in Frail adults with a limited life expectancy) criteria: application to a representative population awaiting long-term nursing care. European Journal of Clinical Pharmacology. 2019;75(5):723–731. PMID 30685856 · DOI 10.1007/s00228-019-02630-3.
  12. Curtin D, Gallagher P, O’Mahony D. Deprescribing in older people approaching end-of-life: development and validation of STOPPFrail version 2. Age and Ageing. 2021;50(2):465–471. PMID 32997135 · DOI 10.1093/ageing/afaa159.

Bibliographic records on this page were retrieved from PubMed. Every reference links to its DOI or PubMed record.

Written and medically reviewed by Dr. Gurpreet Singh Padda, MD, MBA, MHP, founder and medical director of DWARAA. Last reviewed . This page is educational. DWARAA does not prescribe, deprescribe, diagnose or treat.