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Journal Club

Study on the effect of long-term fenofibrate therapy in reducing progression of diabetic retinopathy and laser treatment need in type 2 diabetic patients.

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Journal Club

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  1. Journal Club 亀田メディカルセンター　糖尿病内分泌内科 Diabetes and Endocrine Department, Kameda Medical Center 松田　昌文 Matsuda, Masafumi 2007年12月６日　8:20-8:50 B棟８階　カンファレンス室

  2. NHMRC Clinical Trials Centre(Prof A C Keech FRACP, Prof R J Simes FRACP, D Tse PhD, E Williamson PhD, A Merrifi eld PhD, R L O’Connell MMedStat), Royal Prince Alfred Hospital (Prof A C Keech, Prof R J Simes), Department of Ophthalmology (Prof P Mitchell FRANZCO), and Millennium Institute (M S Moffi tt DipTc), University of Sydney, NSW, Australia; Eye Hosptial, Helsinki University Central Hospital, Helsinki, Finland (P A Summanen FEBO); Department of Ophthalmology (J O’Day FRANZCO) and Royal Melbourne Hospital (Prof P G Colman FRACP), University of Melbourne, VIC, Australia; School of Medicine and Pharmacology, University of Western Australia Fremantle, WA, Australia (Prof T M E Davis MRCP); Department of Medicine (Prof M-R Taskinen MD) and Department of Ophthalmology (Prof L T Laatikainen FEBO), University of Helsinki, Helsinki, Finland; Royal Brisbane and Women’s Hospital, QLD, Australia (M C d’Emden FRACP); and Laboratoires Fournier SCA, Dijon, France (D C Crimet MD)

  3. Background and Aim Laser treatment for diabetic retinopathy is often associated with visual field reduction and other ocular side-effects. Our aim was to assess whether long-term lipid-lowering therapy with fenofibrate could reduce the progression of retinopathy and the need for laser treatment in patients with type 2 diabetes mellitus.

  4. Methods The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a multinational randomised trial of 9795 patients aged 50–75 years with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg/day (n=4895) or matching placebo (n=4900). At each clinic visit, information concerning laser treatment for diabetic retinopathy—a prespecified tertiary endpoint of the main study—was gathered. Adjudication by ophthalmologists masked to treatment allocation defined instances of laser treatment for macularoedema, proliferative retinopathy, or other eye conditions. In a substudy of 1012 patients, standardised retinal photography was done and photographs graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to determine the cumulative incidence of diabetic retinopathy and its component lesions. Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN64783481.

  5. Interpretation Treatment with fenofibrate in individuals with type 2 diabetes mellitus reduces the need for laser treatment for diabetic retinopathy, although the mechanism of this eff ect does not seem to be related to plasma concentrations of lipids.

  6. The Parker Institute, Musculoskeletal Statistics Unit, Frederiksberg Hospital, Frederiksberg, Denmark (R Christensen MSc, P K Kristensen BSc, Prof H Bliddal MD); The Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Copenhagen, Denmark (P K Kristensen, Prof A Astrup MD); and Copenhagen University Library, Copenhagen, Denmark (E M Bartels DSc)

  7. rimonabant

  8. Background Since the prevalence of obesity continues to increase, there is a demand for effective and safe anti-obesity agents that can produce and maintain weight loss and improve comorbidity. We did a meta-analysis of all published randomised controlled trials to assess the efficacy and safety of the newly approved anti-obesity agent rimonabant.

  9. Methods We searched The Cochrane database and Controlled Trials Register, Medline via Pubmed, Embase via WebSpirs, Web of Science, Scopus, and reference lists up to July, 2007. We collected data from four double-blind, randomised controlled trials (including 4105 participants) that compared 20 mg per day rimonabant with placebo.

  10. Interpretation Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events—ie, depressed mood disorders and anxiety—despite depressed mood being an exclusion criterion in these trials. Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions.

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