Clinical trials have shown that statin therapy is effective at reducing the risk of cardiovascular events such as heart attacks or stroke in people who have already experienced such an event (secondary prevention). However, it is not known if statins can prevent or delay these events from occurring for the first time in healthy people (primary prevention). This gap in knowledge is particularly critical for people aged 70 years and over, as very few trials have included enough participants of this age group to be certain if there is a benefit.
In recent years, guidelines released in the US and the UK recommend a more aggressive approach for statin use in people under 75 years of age, which will triple the number of people who are eligible for statin therapy, especially in those aged between 70-75. Due to this, and the predicted increase in the ageing population, resolving the question about statin therapy is of increasing importance for future generations.
Questions about statins that need answering with specific reference to older adults
- Can statins prevent a first heart attack or stroke adults?
- Can statins prevent dementia?
- Can statins improve healthy life expectancy?
- Do statins impact on day to day physical function?
- Are the frequency and/or severity of adverse reactions to statins higher?
- Is the risk of developing diabetes higher?
- Is statin therapy cost effective in healthy?
Statins in Reducing Events in the Elderly (STAREE) will be the first randomised controlled trial (RCT) of statin therapy in an apparently healthy cohort of older adults living independently in the community and will provide the evidence required to determine whether statin therapy should be taken routinely by healthy people aged 70 years and over. Given the growing older population and the increasing health care costs incurred by governments and individuals, this study also has the potential to influence health expenditure in Australia.
STAREE will utilise the resources and expertise in community-based research established in the Australian National Blood Pressure Study (ANBP2) trial and subsequently adapted for the randomised controlled trial of Aspirin in Reducing Events in the Elderly (ASPREE).
The aim of the STAREE study is to determine the effect of statin therapy (40 mg atorvastatin) versus placebo on disability free survival and incidence of major adverse cardiovascular events (myocardial infarction, stroke and cardiovascular death) in a healthy older population (≥70 years)
STAREE is a double-blind, randomised, placebo-controlled trial involving men and women over 70 years of age. STAREE is a community based trial working in collaboration with General Practices across Australia and will run over an average 5-year treatment period.
This project is being carried out in accordance with the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement was developed to protect the interests of trial participants who agree to human research studies.
The ethical aspects of this research project have been approved by the following human research ethics committees:
- Monash University Human Research Ethics Committee (MUHREC)
- RACGP National Research and Evaluation Committee
- Curtin University Human Research Ethics Committee
- University of Tasmania Human Research Ethics Committee
- University of Newcastle Human Research Ethics Committee
You can contact the ethics committee if you have any questions or a complaint about the conduct of the trial. Any of the ethics officers below can be contacted by telephone:
Monash University Human Research Ethics Committee (MUHREC)
Human Research Ethics,
Building 3E, Research Office
Tel: (03) 9905 2052
RACGP Ethics Committee
Executive Officer, National Research and Evaluation Ethics Committee
Royal Australian College of General Practitioners, College House
1 Palmerston Crescent
SOUTH MELBOURNE, VIC 3205
Tel: (03) 8699 0481
University of Tasmania
Executive Officer, Human Research Ethics Committee (Tasmania) Network
Office of Researcher Services
Private Bag 01
Hobart TAS 7001
Tel: (03) 6226 6254
Quote Tasmanian Network project number: H0014918.
University of Newcastle
Executive Officer, Human Research Ethics Committee (University of Newcastle HREC) University of Newcastle
Newcastle NSW 2308
Tel: (02) 4921 7894
Curtin Ethics Officer: (08) 9266 9223
Research Integrity Manager: (08) 9266 7093
Curtin University Human Research Ethics Committee study number (HR113/2015).