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Journal Club
2007年12月６日 8:20-8:50
B棟８階 カンファレンス室
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
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)
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.
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.
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.
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)
rimonabant
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.
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.
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.