[Efficacy and safety of etofibrate in patients with non-proliferative diabetic retinopathy].
BACKGROUND
Diabetic retinopathy is the leading cause of vision loss or blindeness in working-age adults in the developed and developing countries. No curative treatments are available for diabetic retinopathy and the most common symptomatic treatment, laser photocoagulation, provides only partial and temporary relief from the progressive vascular damage caused by this disease. Etofibrate (Lipo-Merz) is an orally-administered treatment for lipid disorders that combines fibrate and nicotinic acid in a slow-release formulation.


METHODS
This report describes the results of a double-blind, randomised, placebo-controlled study, performed to evaluate the efficacy and safety of etofibrat in patients with type 2 diabetes mellitus and concomitant diabetic retinopathy. They received either placebo or 1000 mg/day etofibrate for up to 12 months. Efficacy analyses were based on visual acuity assessment and blinded expert ratings of ocular fundus pathology, as well as laboratory analyses of serum lipid parameters.


RESULTS
The evaluable population comprised 296 patients, 148 in each treatment group, of whom 89% completed the study and 73% completed according to protocol. After 12 months of treatment, a significantly larger population of etofibrate-treated patients than placebo-treated patients showed improvements in ocular pathology (46% versus 32%, respectively, p < 0.001); similar findings were already apparent after 6 months of treatment (43% versus 31%, respectively p < 0.001). Etofibrate treatment also produced significant improvements in total cholesterol, LDL-cholesterol and HDL-cholesterol in comparison to the placebo treatment group. Safety evaluations (adverse events, laboratory parameters) did not reveal any clinically significant adverse effects of etofibrate in comparison to placebo.


CONCLUSIONS
Etofibrate provides a safe and effective treatment for ocular pathology resulting from type 2 diabetes mellitus.
Emmerich
K-H
KH
Augenklinik, Klinikum Darmstadt, Darmstadt. augenklinik@klinikumdarmstadt.de
Poritis
N
N
Stelmane
I
I
Klindzane
M
M
Erbler
H
H
Goldsteine
J
J
Görtelmeyer
R
R
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D002995:Clofibric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003930:Diabetic Retinopathy / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D016896:Treatment Outcome; D055815:Young Adult
D000960:Hypolipidemic Agents; C009746:etofibrate; D002995:Clofibric Acid