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Information for GPs

FAQs

STAREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment of 40 mg atorvastatin will enhance disability free survival (death, dementia and disability) and prevent major cardiovascular outcomes in healthy participants aged 70 years and over.

Why be a GP Co-Investigator in the STAREE study?

  • This trial of vital interest to general practitioners and their patients, will address an important question in regards to statin use in those aged 70 years and over.
  • STAREE examines the nett effects (risks and benefits) of statin therapy in elderly individuals free of established vascular disease and diabetes.
  • Largest single project grant yet awarded by NHMRC.
  • The work required for the study is conducted by the STAREE research staff.
  • Administrative reimbursement of $100/ randomised patient made to your practice.
  • In conjunction with STAREE, a RACGP CPD program will be offered over the course of the next triennium.
  • The trial is coordinated by Monash University.
  • The researchers undertaking STAREE have previously conducted research in general practice, publishing widely (acknowledging all co-investigators) including:
    The Reduction of Atherothrombosis for Continued Health (REACH) Registry, Australian National Blood Pressure Study (ANBP2) and Aspirins in Reducing Events in the Elderly (ASPREE).

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:

How to get involved

Are you interested in becoming a GP co-investigator?

We’re recruiting in Victoria, Western Australia, South Australia, Tasmania, Queensland and New South Wales.

Please contact us on 1800 770 664 to speak to a STAREE staff member or email: staree@monash.edu.

CPD program for GPs

Medical practitioners have the opportunity to use their participation in the STAREE clinical trial to gain RACGP CPD program points over the course of the following triennium. The current triennium ends 2019.

GP co-investigators who register for CPD Category 2 points are awarded 30 points for study related activities that equate to a maximum of 15 hours of self-directed involvement which could include baseline screening of potential participants.

The STAREE clinical trial can also be used as a self-directed Category 1 activity, however the co-investigator must submit an online application form at racgp.org.au/education/professional-development/qi-cpd/self-directed-learning.

The form will require you to list all your supporting activities of the STAREE clinical trial including participation in reinforcing activities such as further research or development of the trial.

If you have any enquiries or need further information please contact the RACGP on 1800 331 626 or email: racgp@racgp.org.au.

Misinformation about STAREE

In August 2017, incorrect claims about the STAREE trial were made via national radio and social media. A pharmacist and master herbalist, made these claims on a nationally syndicated guest spot on Macquarie Radio, on the website i2p.com.au and on his own social media pages.

They incorrectly claimed that STAREE is funded by pharmaceutical companies and is a ‘sneaky’ move by ‘big pharma’ which targets vulnerable Australians. He encouraged prospective participants to ‘rip up’ their patient information and consent forms.

STAREE receives funding from the National Health and Medical Research Council. We are proud of our independence from pharmaceutical funding. We believe this builds trust with the community and reduces researcher biases.

STAREE and its associated participant communications have been reviewed by an ethics committee for transparency, clarity and accuracy.

The risks and benefits of statins in the healthy elderly have never been addressed in a large, independent population based trial. The trial fills a gap in the literature that the NHMRC has deemed of value to society.

The claims that STAREE is taking advantage of elderly Australians who are likely to feel pressured into participating are unfounded. The claims appear to universally equate ‘elderly’ with ‘vulnerable’. STAREE participants can only join the trial with the approval of their GP and following a mandatory health check. This ensures that healthy people, capable of making free and informed consent decisions join the study.

Many older Australians are physically healthy, mentally alert and maintain their capacity to make sound decisions. The decision to contribute to medical research often provides them with personal pride and a sense of purpose.

False claims such as these needlessly undermine the public’s trust in medical research. Without that trust, medical research in this country grinds to a halt.

If you have a patient participating in STAREE who has expressed these or similar concerns to you, we ask that you encourage them to speak directly to study staff. We have patient-focused resources available on our website.

FAQs for GPs

This page answers some frequently asked questions by GPs. The information on this page has been condensed. You can obtain a more detailed FAQ by downloading this PDF.

GP Summary

Atorvastatin has been selected for this pragmatic community based trial as it’s the most commonly prescribed statin in Australia, has a favourable side effect profile and is one of the most potent statins in reducing LDL concentrations.

The Cholesterol Treatment Trialist Collaborations (CTTC) meta-analyses published in September 2016, reported that a typical regimen, such as atorvastatin 40mg, taken for 5 years in 10,000 patients (age range 40-70 years) would on average prevent a major cardiovascular event in 1000 patients for secondary prevention and 500 patients for primary prevention, with smaller proportions of patients experiencing adverse events; 5 cases of myopathy, 50-100 new cases of diabetes and 5-10 cases of haemorrhagic stroke.

STAREE will answer the important question regarding the balance between expected benefits versus harms for preventive treatment in people aged over 70 years where the evidence is currently lacking.

What do we know about statins for primary prevention in older adults?

Data from randomised controlled trials (RCTs) about the benefits and risks of statins for primary prevention for adults older than 70 years are limited, as relatively few older adults have participated in trials to date. PROSPER, the only study to specifically study statin use in older persons, combined both primary and secondary prevention populations. Hence why STAREE (Statins in Reducing Events in the Elderly) addresses a critical knowledge gap and aims to provide the evidence to support practice guidelines for primary prevention in a large community-based sample of people over 70 years of age.

Why was atorvastatin chosen for the STAREE study?

  • Most commonly prescribed statin in Australia
  • At low to standard dosing (20-40mg) it has favourable side effect profile
  • One of the most potent treatments in reducing LDL-C

What is the risk for incident diabetes being on statin therapy?

  • About 1% (100 cases in 10,000 treated) new incident cases expected
  • Most likely in patients who had existing risk factors for type 2 diabetes

Within STAREE, participants will be considered to have developed diabetes if HbA1c ≥ 6.5% (48 mmol/mol) and Fasting Blood Glucose > 7.0mmol/L. Participants can enter the study with impaired fasting glucose if they have a normal Hba1c level. Once randomised to study treatment, participants who develop incident diabetes will be followed up on or off study medication; the latter if prescribed open label statin treatment.

How common are muscle symptoms? Who are at greatest risk?

  • Myalgia is commonly reported in older adults on statin therapy and also on placebo
  • Myopathy is rare
  • Statin associated symptoms are dose dependent, symmetrical and reversible

Myopathy is rare and the incidence of rhabdomyolysis is about 2-3 cases per 100, 000 treated patients1. The precise mechanisms causing statin induced muscle symptoms are not well-understood yet they are likely dose dependent, occur typically with 4 weeks of treatment but may occur even after therapy has been tolerated for up to 1 year, and is a leading reason for treatment withdrawal2-4.

The estimated incidence of statin myopathy in trials has ranged from 1.4 to 5% and higher with higher doses of statin (> 40mg). Older age, female gender and concomitant use of inhibitors of cytochrome P450 3A4 are recognised risk factors for the development of statin myopathy5-7.

If patients complain of muscle symptoms, the EAS Society Consensus Panel reccomends that clinicians should:

  • Evaluate risk factors that may pre-dispose to SAMS (female gender, ethnicity, multisystem disease and small body frame)
  • Exclude secondary causes (e.g. hypothyroidism)
  • Review other medications that may cause muscle related side effects
  • Review drug-drug interactions that may incease the risk of SAMS

Statin-associated muscle adverse events are likely to be symmetrical, affect large muscle groups and disappear when treatment is ceased. Within STAREE, participants who report muscle adverse effects may be offered a treatment rechallenge at a lower dose.

Managing patients who are identified with elevated creatine kinase (CK)

  • The incidence of elevated CK levels in patient treated with statin therapy is uncertain
  • Myopathy and rhabdomyolysis occur rarely
  • A number of factors impact upon CK levels so specificity of this result, pertaining to statin myopathy, is low.

It is recommended that all likely causes for elevated CK levels are investigated.

Managing patients who are identified with elevated transaminases (AST & ALT)

  • The incidence of true liver injury caused by statin therapy is low
  • In statin-treated patients, an increase in liver enzymes may be due to different aetiologies, which should be considered before assuming the increase in liver enzymes is due to the statin.

Up to one third of the population may have asymptomatic elevations in ALT at any one time8. Elevations may be due to pre-existing conditions such as non-alcoholic fatty liver disease or viral hepatitis, or may non-pathological. Mild elevations in liver tests such as ALT are not a contraindication to statin therapy. However persistent and substantial elevations in liver enzymes such as ALT should be investigated in the usual way before commencing treatment with statins, and specialist opinion may be informative.

In STAREE, AST and ALT levels are tested annually. A notification letter will be sent to the treating GP if an abnormality is detected, namely if the levels are 3 times the upper limit of normal (i.e. Melbourne Path: AST > 90 IU/L and ALT > 105 IU/L). It is recommended these people are followed up with their GP, and potentially re-tested, in 6 weeks.

Statin treatment in patients with low baseline LDL levels – are there clinical concerns?

  • No adverse events reported to date with LDL-C lowering to 1.4 mmol/L
  • However the proportional balance between benefits and risks in people aged over 70 years is not known

Do statins cause memory loss or changes in cognitive performance in older people?

  • Whether statins are beneficial, harmful or have no effect on cognition in older people with normal cognition or impaired cognition is unknown.
  • While memory and/or cognitive changes are frequently reported by patients taking statin therapy, on balance, the current available literature, which is limited, does not suggest that statins have adverse effects on cognition.

Overall, considering all available studies that have been conducted in older populations, and their limitations, there is moderate evidence that statins:

  • do not increase the risk of dementia in the elderly
  • do not increase the risk for mild cognitive impairment in the elderly
  • do not worsen global cognitive performance in the cognitively intact or impaired
  • do not worsen memory function in the elderly.

There is low strength evidence that statins do not increase the risk of Alzheimer’s disease.9

Clinicians should be open to patient complaints of cognitive or memory change.

If a cognitive deficit is found it is important to screen for other causes (e.g. hypothyroidism, vitamin B12 deficiency, depression) and actively screen for and treat cerebrovascular risk factors such as hypertension and diabetes.

Appropriate referral for formal neurocognitive examination, screening and if indicated, treatment, may be required.

Useful Links

References

1. Holbrook, A., Wright, M., Sung, M., Ribic, C. & Baker, S. Statin-associated rhabdomyolysis: is there a dose-response relationship? The Canadian journal of cardiology 27, 146-151 (2011).

2. Collins, R., et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet (2016).

3. Law, M. & Rudnicka, A.R. Statin safety: a systematic review. The American journal of cardiology 97, 52C-60C (2006).

4. Ganga, H.V., Slim, H.B. & Thompson, P.D. A systematic review of statin-induced muscle problems in clinical trials. American heart journal 168, 6-15 (2014).

5. Thompson, P.D., Clarkson, P.M., Rosenson, R.S. & National Lipid Association Statin Safety Task Force Muscle Safety Expert, P. An assessment of statin safety by muscle experts. The America journal of cardiology 97, 69C-76C (2006).

6. Rosenson, R.S., et al. An assessment by the Statin Muscle Safety Task Force: 2014 update. Journal of clinical lipidology 8, S58-71 (2014).

7. Joy, T.R. & Hegele, R.A. Narrative review: statin-related myopathy. Annals of internal medicine 150, 858-868 (2009).

8. Lazo, M., Selvin, E. & Clark, J.M. Brief communication: clinical implications of short-term variability in liver function test results. Annals of internal medicine 148, 348-352 (2008).

9. Samaras, K., Brodaty, H. & Sachdev, P.S. Does statin use cause memory decline in the elderly? Trends in cardiovascular medicine 26, 550-565 (2016).

How to become a co-investigator

Contact the STAREE centre Have a visit from one of
our GP recruiters
Sign on as a co-investigator Send a letter to your patients