Fenofibrate finds fame


Diabetic retinopathy (DR) is the leading cause of preventable blindness of working-age adults in the world.1

In Australia it is one of the top five causes of irreversible blindness among adults.1,2 Of the 1.7 million Australians with diabetes, including an estimated 500,000 people with undiagnosed diabetes, more than 300,000 people have some degree of DR—while about 65,000 have progressed to more advanced, sight-threatening disease.1,2

However, two major clinical trials3-5 demonstrated that fenofibrate slowed DR and reduced the need for laser eye surgery. And when combined with simvastatin, there was a 40% reduction in DR progression over four years. This occurred with an increase in HDL-cholesterol and a decrease in the serum triglyceride levels in the fenofibrate group and was independent of glycaemic control—it also offered protection against diabetic kidney and nerve damage.

Lipidil is the only branded fenofibrate indicated for DR in type 2 diabetes (T2D) and the only fibrate currently recommended for combination therapy with a statin.6

Now researchers at the University of Sydney’s Clinical Trials Centre (CTC) are turning their attention to how the drug might work in people living with type 1 diabetes (T1D).

In a world first study,7 funded by the NHMRC and JDRF Australia, the CTC is leading the FAME-1 Eye trial to determine if fenofibrate can achieve similar results for those adults with T1D and early eye damage.

“We already know fenofibrate slows and reverses vision loss for T2D diabetes, as well as protect against kidney and nerve damage, said study lead, Professor Alicia Jenkins. “We are now calling for people around the world to help us find out if this is the case for those with the more severe type 1 diabetes. Type 1 diabetes has many potential health complications. Fenofibrate could potentially lighten the load and give people a better quality of life with fewer long-term health risks,” says Prof Jenkins.

In the study non-invasive photography is used to detect if fenofibrate can help protect retina tissue in T1D. Researchers are hoping to show the drug can slow existing eye damage and even reverse it. If it does, fenofibrate could also help other tissues in the body and avoid other major and common health complications later, such as amputations and heart disease.

The trial is currently recruiting in 18 sites across Australia, New Zealand and Hong Kong, and has already recruited close to half of the required 450 participants.

For more information, contact fame1eye@ctc.usyd.edu.au.


ATSI eye health tests rise

More Aboriginal Torres Strait Island (ATSI) people are accessing eye health services, according to the results of the fourth Indigenous eye measures 2020,1 released by the Australian Institute of Health and Welfare (AIHW).

The report provides an evidence-base for monitoring changes in Indigenous eye health over time. It found 30% of people had an eye check in 2018–19, up 11% on 2010–11 and around 44% of indigenous Australians who had a diabetes test were screened for diabetic retinopathy in 2018–19. While the prevalence of active trachoma in children aged 5–9 in at-risk communities fell from 15% in 2009 to 4.5% in 2019.

National Aboriginal Community Controlled Health Organisation (NACCO) chair, Donella Mills, said the results point to the success of programs like 715 Checks—the free GP health assessment to ensure ATSI people receive primary healthcare and early detection, diagnosis and intervention for common and treatable conditions.

“This has led to substantial improvements in the rate of indigenous Australians accessing cataract surgery, diabetic retinopathy screening and eye health exams growing from 11% to 30%. The prevalence of trachoma, a highly infectious eye disease can cause blindness if left untreated, has fallen significantly among ATS I children.

“These improvements in eye health for our people [is] a reflection of the good work done by Aboriginal Community Controlled Health Services and proves the fact that culturally appropriate services can deliver results and needs to be supported.

“NACCO continues its work with Vision 2020 Australia in the National Spectacle Subsidy Scheme to increase access to subsidised glasses for all ATSI people, as well as working in implementing the five-year plan for eye and vision health—strong eyes, strong communities.”

Researchers at the University of Sydney are also working on ways to improve the vision and eye health of ATSI peoples. For example, its Clinical Trials Centre (CTC) is training indigenous health workers in how to screen people—with now nearly 20 newly trained workers having screened more than 600 people with type 2 diabetes. Additionally, they are integrating eye screening programs into care programs. This has resulted in more than 150 indigenous Australians with diabetes attending a primary care clinic for eye health screening.

To find out more contact, Professor Anthony Keech, deputy director, NHRC clinical trials centre. Email: anthony.keech@sydney.edu.au

  1. Indigenous eye health measures 2020. AIHW; 05 Nov 2020. Available at: https://www.aihw.gov.au/reports/indigenous-australians/indigenous-eye-health-measures-2020/summary

References

  1. Reducing the risk of diabetic retinopathy. Macular Disease Foundation Australia. Available at: https://www.mdfoundation.com.au/content/risk-factors-associated-diabetic-retinopathy
  2. Dirani M. Out of sight—a report into diabetic eye disease in Australia. Baker IDI Heart and Diabetes Institute and Centre for Eye Research Australia; 2013.
  3. Keech A, et al. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trail. Lancet. 2007;370(9600):1687-97.
  4. The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye. (FAME 1 EYE). Available at: https://clinicaltrials.gov/ct2/show/NCT01320345
  5. Chew E, et al. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: The ACCORD Eye Study. Opthalmology. 2014;121(12):2443-51.
  6. Lipidil: fenofibrate tablet. Australian Product Information. Available at: https://apps.medicines.org.au/files/goplipid.pdf
  7. The Fenofibrate And Microvascular Events in Type 1 diabetes Eye: A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabete. A multicentre double-blind placebo-controlled study in Australia and internationally. Available at: http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000249954

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