A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)

The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).

Sex

All

Minimum age

70 Years

Inclusion Criteria:

* Men and women aged ≥70 years living independently in the community
* Willing and able to provide informed consent and accept the study requirements (Note: competent physical ability to participate in the trial is assessed using the KATZ ADL questionnaire)

Exclusion Criteria:

A history of cardiovascular disease (defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, coronary artery angioplasty and/or stenting, coronary artery bypass grafting, carotid stenosis, abdominal aortic aneurysm or heart failure),

* A history of dementia or a 3MS score \<78 on screening,
* A history of diabetes,
* Total cholesterol \>7.5 mmol/L,
* Moderate or severe chronic kidney disease (persistent proteinuria (Urine albumin:creatinine ratio \>30mg/mmol or Urine protein:creatinine ratios \>45 mg/mmol)45 and/or eGFR \<45ml/min/1.73m2),
* Moderate or severe liver disease (persistent elevations of transaminases of more than 3 times the upper limit of the normal laboratory reference range),
* Serious inter-current illness likely to cause death within the next 5 years such as terminal cancer or obstructive airways disease,
* Current participation in a clinical trial,
* Absolute contraindication to statin therapy,
* Current use of statin therapy or other lipid lowering therapy for primary prevention and unwilling to stop therapy,
* Current long term or permanent use of the following cytochrome P450 (CYP) 3A4 inhibitors : Amiodarone, Boceprevir, Cimetidine, Cyclosporin, Danazol, Fosamprenavir, Indinavir, Lopinavir + Ritonavir, Erythromycin, Fluconazole, Itraconazole, Ketoconazole.

• DERIVEDZoungas S, Wolfe R, Moran C, Nicholls SJ, Cloud GC, Reid CM, Tauonkin AM, Beilin L, Wierzbicki AS, Chong TT, Broder JC, Curtis AJ, Flanagan Z, Hopper I, Ryan J, Spark S, McNeil JJ, Nelson MR; STAREE Investigators. Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2607314. Online ahead of print. PMID 42670961
• DERIVEDZoungas S, Moran C, Curtis AJ, Spark S, Flanagan Z, Beilin L, Chong TT, Cloud GC, Hopper I, Kost A, McNeil JJ, Nicholls SJ, Reid CM, Ryan J, Tonkin AM, Ward S, Wierzbicki AS, Wolfe R, Zhou Z, Nelson MR; STAREE investigator group. Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability-Free Survival in Older People. J Am Heart Assoc. 2024 Nov 19;13(22):e036357. doi: 10.1161/JAHA.124.036357. Epub 2024 Nov 15. PMID 39548016
• DERIVEDZoungas S, Curtis A, Spark S, Wolfe R, McNeil JJ, Beilin L, Chong TT, Cloud G, Hopper I, Kost A, Nelson M, Nicholls SJ, Reid CM, Ryan J, Tonkin A, Ward SA, Wierzbicki A; STAREE investigator group. Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial). BMJ Open. 2023 Apr 3;13(4):e069915. doi: 10.1136/bmjopen-2022-069915. PMID 37012015
• DERIVEDRozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16. PMID 36413436