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About STAREE

Key Messages | Funding and Collaboration | Our Team

Rationale

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).

Aim

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)

Study Design

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.

Ethics Approval

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:

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)

Executive Officer,
Human Research Ethics,
Building 3E, Research Office
Monash University
Victoria 3800
Tel: (03) 9905 2052

Email: muhrec@monash.edu

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
E-mail: ethics@racgp.org.au

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
Email: human.ethics@utas.edu.au
Quote Tasmanian Network project number: H0014918.

University of Newcastle

Executive Officer, Human Research Ethics Committee (University of Newcastle HREC) University of Newcastle
University Drive
Newcastle NSW 2308
Tel: (02) 4921 7894
Email: human-ethics@newcastle.edu.au

Curtin University

Curtin Ethics Officer: (08) 9266 9223
Research Integrity Manager: (08) 9266 7093
Email: hrec@curtin.edu.au
Curtin University Human Research Ethics Committee study number (HR113/2015).

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Key Messages

STAREE study main principles

  1. STAREE is a community based, public health trial that is funded by government and non-profit health organisations. STAREE is not sponsored by pharmaceutical industries.
  2. STAREE is the only statin-placebo control, double-blind, randomised trial exclusively enrolling older adults.
  3. STAREE will determine if the benefits of statin therapy outweigh the risks of adverse effects for initially healthy older adults.
  4. STAREE will determine whether statins can extend healthy life expectancy and independent living and improve quality of life in the older population.
  5. STAREE will provide clinicians and older adults with evidence-based data which will guide decisions about whether they should prescribe or take a statin.

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Funding and Collaboration

Funding

STAREE is funded by grants from the National Health and Medical Research Council and the Heart Foundation.

Collaborators

  • The Menzies Research Institute, University of Tasmania
  • University of Western Australia
  • Australian National University
  • Curtin University
  • University of Newcastle