This document discusses the use of fenofibrate to treat diabetic retinopathy. It summarizes two studies - the FIELD study and ACCORD study. The FIELD study found that fenofibrate reduced the need for laser treatment for diabetic retinopathy by 30% and slowed the progression of existing retinopathy by 79%. However, it did not reduce retinopathy progression in all diabetics. The ACCORD study found no benefit of fenofibrate on retinopathy progression. The document concludes that fenofibrate may be useful for mild to moderate non-proliferative diabetic retinopathy but not for prevention or reducing mortality without retinopathy.
2. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
DIABETIC MACULAR OEDEMA
PROLIFERATIVE DIABETIC
RETINOPATHY
3. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
Duration of diabetes
Diabetic control
Hypertension
Lipid control
Anaemia
Pregnancy
4. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
0
10
20
30
40
50
60
70
80
90
<10 yrs 10-20 yrs >20 yrs
Any DR
PDR
DME
Yau et al. Global prevalence and major risk factors of diabetic
retinopathy. Diabetes Care. 2012 Mar;35(3):556-64
5. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
0
10
20
30
40
50
60
≤ 7.0 % 7.1-8.0 % 8.1-9.0 % >9.0 %
Any DR
PDR
DME
Yau et al. Global prevalence and major risk factors of diabetic
retinopathy. Diabetes Care. 2012 Mar;35(3):556-64
6. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
0
5
10
15
20
25
30
35
40
45
Normotensive Hypertensive or treated
Any DR
PDR
DME
Yau et al. Global prevalence and major risk factors of diabetic
retinopathy. Diabetes Care. 2012 Mar;35(3):556-64
7. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
< 4 mmol/L ≥ 4.0 mmol/L
0
5
10
15
20
25
30
35
Any DR
PDR
DME
Yau et al. Global prevalence and major risk factors of diabetic
retinopathy. Diabetes Care. 2012 Mar;35(3):556-64
8. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
n=10251
RCT evaluating strategies for treating:
Blood glucose levels (HbA1C <6% vs 7-8%)
Serum lipid levels (Simvastatin +/- fenofibrate)
Blood pressure (SBP <120 vs SBP <140)
In type 2 diabetic with cardiovascular disease
or known cardiovascular risk factors.
The ACCORD Study Group and ACCORD Eye Study Group. Effects of Medical Therapies on Retinopathy
Progression in Type 2 Diabetes N Engl J Med 2010; 363:233-244
9. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
No CVD benefit in intensive BP control
IncreasedCVD deaths and all cause deaths
with intensive glycaemic control- arm
stopped at 3.5yrs ? hypoglycaemia
No CVD benefit in intensive lipid treatment
10. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
No effect on preventing moderate vision loss
(p=0.57)
Effect independent from control of LDL-C,
glycaemia and blood pressure
No difference with or without atherogenic
dyslipidaemia at baseline
Suggests effect of fenofibrate is not related
to its lipid effects
11. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
12. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
n= 9795
RCT evaluating fenofibrate 200mg od vs
placebo in CVD rates stratified by metabolic
syndrome in well controlled (HbA1C <7%)
T2DM
Prof AC Keech, et al. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD
study): a randomised controlled trial The Lancet - 17 November 2007 ( Vol. 370, Issue 9600, Pages 1687-1697 )
13. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
1°-Nonfatal MI/CHD death ↓11% (p=0.16)
2°-Total CVD deaths ↓11% (p=0.035)
3°
Laser for oedema/retinopathy ↓30% (p=0.0003)
Progression of existing retinopathy ↓79%
(p=0.004) but not all diabetics ↓22% (p=0.19)
Progression of albuminuria (p=0.002)
↓ Non traumatic amputations (p=0.011)
Macrovascular
Microvascular
14. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
15. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
No.Why?
Doesn’t prevent progression in those with no
diabetic retinopathy (or reduce mortality)
Who then?
Mild to moderate non proliferative diabetic
retinopathy (to prevent laser and
progression)
Possibly more severe retinopathy, or diabetic
macular oedema (not studied)
16. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
FIELD used 200mg
ACCORD used 160mg
Lipidil is sold in 48mg and 145mg tablets
The formulations have a different particle
size, but same bioavailability so:
200mg = 160mg = 145mg = 3 x 48mg
17. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
Both have muscle aches as side effects
Reversible increase in Cr
Risk of rhabdomyolysis rare
NOT increased with statin use (cf gemfibrozil)
Dose adjustment if eGFR <60
18. Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO
Questions?
Dr Derek Chan
Cataract, Medical Retina
and General Ophthalmology
BSc(Med)MBBS(Hons)MPHFRANZCO