Abstract

SO.08.01

Efficacy of Etofibrate in the treatment of diabetic retinopathy

Emmerich K.-H.¹, Erbler H.², Görtelmeyer R.³, Poritis N.⁴, Klindzane I.^5
1Städtische Klinken Darmstadt, Darmstadt; ²Department of Pharmacology and Clinical Phamacology, Medizinische Hochschule, Hannover; ³Department of Scientific Methodology & Evaluation, Merz Pharmaceuticals GmbH, Frankfurt/Main; ⁴Central Ophthalmologist, Riga; ⁵Baltic Institute of Pharmaceutical Investigation and Consulting, Riga

Objective: Diabetic retinopathy is a debilitating disease that results from microvascular changes in the retina. It affects more than 40% of patients with type II diabetes mellitus, and can lead to severe visual disability or blindness. Previous research has shown that diabetic patients with high serum lipid levels have an increased incidence and severity of diabetic maculopathy.
This report describes a randomized, placebo-controlled, double-blind study involving nearly 300 patients with type II diabetes mellitus. The study was performed to evaluate the efficacy of Etofibrate therapy in the treatment of diabetic retinopathy and exudative maculopathy.
Methods: Etofibrate (Lipo-Merz^® retard) is an orally administered compound that has been used for more than 30 years for the treatment of patients with disorders of lipid metabolism. Patient recruitment for the current study involved screening of more than 10,000 patients with type II diabetes. Of these, 296 patients with diabetic retinopathy and lipid values outside the normal range were randomized to receive either 500 mg twice daily Etofibrate or matching placebo capsules. Patients were treated for 12 months, during which five clinical visits were performed (at screening, and 3, 6, 9 and 12 months after the start of treatment). The clinical visits included ophthalmological evaluations, visual acuity assessments, laboratory analyses of serum lipid parameters, and evaluation of adverse events.
Results: After 12 months of treatment, a significantly higher percentage of patients randomized to Etofibrate treatment showed an improvement in retinal pathology as compared to patients randomized to placebo (46% versus 32%, p<0.001). In addition, patients treated with Etofibrate showed significant improvements in serum lipid levels (total cholesterol, LDL-cholesterol and HDL-cholesterol) as compared to placebo patients. Safety evaluations showed no clinically relevant adverse effects of Etofibrate treatment.
Conclusions: The result of this study show that Etofibrate is a safe and effective treatment for diabetic retinopathy in patients with type II diabetes mellitus.

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