Are there any risks?
Most treatments have side-effects which some people may experience and others may not. Fenofibrate is usually well tolerated with no serious safety problems. The ‘run-in phase’ will also give us a good chance to check that you have no problems with the tablets. We will send you a questionnaire every 6 months which specifically asks about your recent health. In addition, the research team will monitor your medical records regarding any admissions to hospital and any routine blood tests which you have. You can withdraw from the trial at any time if you wish and this will have no impact on your usual NHS care.
Fenofibrate is a licensed drug in the UK for treating people with raised cholesterol levels but it is not currently licensed for treating diabetic retinopathy. In LENS we are testing whether fenofibrate should be used as a treatment for patients with diabetes and retinopathy. Fenofibrate can be taken safely regardless of whether you are on a statin or not, as already confirmed in major studies. It is also safe to take with the vast majority of other medicines. We will check that you are not on any medicines which cannot be taken with fenofibrate. It is well known that treatment with fenofibrate often causes a small rise in a blood test called creatinine, which is a test of kidney function. However, creatinine then quickly returns to one’s normal level when fenofibrate is stopped, so there is no evidence that using fenofibrate harms the kidney in any way. You will receive a Treatment Information Leaflet with more details before entering the ‘run-in’ phase.
In large trials of fenofibrate and similar drugs (called fibrates), those treated with fibrates had a lower risk of suffering heart attacks and foot amputations.
If you do experience side effects, you may choose or be advised by your doctor to stop the trial tablets. There is nothing to suggest that stopping the tablets will cause you any harm. If you experience unexpected symptoms after joining the trial you can contact your LENS research nurse, or a trial doctor on Freephone 0808 164 5090 (available 24 hours a day, 7 days a week).
The effects of fenofibrate on the unborn child and on children being breast-fed are not definitively known. For this reason fenofibrate should not be taken by women who are pregnant, planning to become pregnant, or breast feeding, and these women cannot take part in the trial. Women who could become pregnant must use effective and reliable contraception during the study and for 7 days after the end of the study (i.e. after stopping study treatment). If you become pregnant during the trial (or plan to become pregnant), you should tell your research nurse or the LENS trial doctors immediately so appropriate steps can been discussed.