MedicalResearch.com Interview with:
Prof. Michael d’Emden
Endocrine Research Unit
Royal Brisbane Hospital, Brisbane, Australia
Medical Research: What are the main findings of the study?
Prof. d’Emden: Our study is the largest trial of women having type 2 diabetes assessing the role of a fibric acid derivative, in this case fenofibrate, ever conducted. There were 3657 female subjects randomized to placebo or fenofibrate. The study demonstrated greater reductions in women of total cholesterol, triglycerides and LDL-cholesterol and greater increases in HDL-cholesterol. In women, fenofibrate decreased total cardiovascular end-points by 30% compared with only 13% in men, although there was no-treatment-by-sex interaction. The majority of end points assessed revealed a consistent trend to increased benefit being seen in women.
Medical Research: Were any of the findings unexpected?
Prof. d’Emden: The increased effectiveness in women was surprising. Greater reductions in women of total cholesterol, triglycerides and LDL-cholesterol and greater increases in HDL-cholesterol had not been observed before. The fact that there were consistently greater trends for benefits in CVD end points was unexpected, but was in keeping with the lipid changes.
The findings of improvements in microvascular disease were also novel and potentially important opening the possibility for therapies to decrease retinopathy, nephropathy and peripheral neuropathy/peripheral vascular disease through alternative pathways.
Medical Research: What should clinicians and patients take away from your report?
Prof. d’Emden: Fenofibrate is a safe and effective therapy to be considered for use in persons with type 2 diabetes who are on statin therapy but who remain dyslipidaemic. It should also be considered in patients with type 2 diabetes who have evidence of retinopathy.
Medical Research: What recommendations do you have for future research as a result of this study?
Prof. d’Emden: The microvascular findings were novel and important. Are there benefits seen in persons with type 1 diabetes? Do we completely know the biological effect of fenofibrate to reduce retinopathy? Are there other agents that could be more effective at modulating this pathway(s)?
Michael C. d’Emden & Alicia J. Jenkins & Liping Li & Diana Zannino & Kristy P. Mann &James D. Best & Bronwyn G. A. Stuckey & Kris Park & Juha Saltevo & Anthony C. Keech & on behalf of the FIELD Study Investigators