Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Diabetes Mellitus

Dementia

Lipid Regulating Agents

All Drugs and Chemicals

Antihypertensive Agents

Channel Blockers

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Amlodipine, atorvastatin drug combination

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily

Placebo (2 x 20 mg placebo) taken orally once daily

Inactive pill manufactured to mimic Atorvastatin 20 mg tablet

Placebo (for Atorvastatin)

Sophia Zoungas, MBBS, FRACP

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).

Statin therapy has been shown to reduce the risk of vascular events in younger individuals with manifest atherosclerotic disease or at high risk of vascular events. However, data derived from meta-analyses of existing trials suggests that the efficacy of statins may decline sharply amongst those over 70-75 years of age. Insufficient patients of this age group have been included in major trials to be certain of the benefit. Within this age group part of the benefit of statin therapy may be offset by adverse effects including myopathy, development of diabetes, cancer and cognitive impairment, all of which are more prevalent in the elderly in any event.

The use of statins in the over 70 age group raises fundamental questions about the purpose of preventive drug therapy in this age group. When a preventive agent is used in the context of competing mortality, polypharmacy and a higher incidence of adverse effects its use should be justified by an improvement in quality of life or some other composite measure that demonstrates that the benefit outweighs other factors.

STAREE will determine whether taking daily statin therapy (40 mg atorvastatin) will extend the length of a disability-free life, determined from survival outside permanent residential care, in healthy participants aged 70 years and above.

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

A Study of STAtins for Reducing Events in the Elderly (STAREE)

On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)

Defined as the first occurrence of a non-fatal myocardial infarction, non-fatal stroke or cardiovascular death

Hospitalisation reasons and length of stay

Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)

Cognitive decline as assessed using cognitive tests excluding depression

Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).

Fatal and Non-fatal Stroke can be a) haemorrhagic or b) thromboembolic

All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures) or external diagnosis

Spots Global Cancer Trial Database for placebo (for atorvastatin)