Doxium® slows progression of diabetic retinopathy
July 21, 2006

About 200 patients with type II diabetes and early diabetic retinopathy were included in this new placebo-controlled study of Doxium® (calcium dobesilate) conducted by Dr Ribeiro and other international specialists. It is now published in Graefes Archives of Clinical and Experimental Ophthalmology. The patients were treated with 4 capsules of Doxium® (2 g of active principle) or placebo per day for 2 years in Portugal, Hungary, Austria and France.

The primary efficacy parameter, posterior vitreous penetration ratio, measured by fluorophotometry in order to evaluate vascular leakage from the retina, shows a decrease by 3.87 (-13.2%) under Doxium as opposed to a 2.03 (+7.3%) increase under placebo after 2 years, giving a highly significant difference between the 2 groups (p=0.002).
This efficacy of Doxium® was demonstrated versus placebo whether the diabetes was well controlled or not, as determined by the patients’ glycosylated haemoglobin (HbA1c) level: -7.94 vs -0.37 in well controlled diabetes (HbA1c <7.0%), -2.00 vs +1.66 in moderately controlled diabetes (HbA1c ≥7-<9%) and -2.23 vs +5.13 in poorly controlled diabetes (HbA1c ≥9%).
An additional analysis of the primary parameter in a subgroup of patients without antihypertensive and/or lipid-lowering agents showed also a significant difference between the 2 groups: -3.38 under Doxium® versus + 3.50% under placebo.
The clinical secondary parameters of haemorrhages, microaneurysms and level of diabetic retinopathy were all markedly and significantly improved at the last available visit in the Doxium® group with respect to placebo.

Tolerance was very good with only 5 of the reported adverse events being considered to be possibly or probably drug-related (3 in Doxium® group and 2 in placebo group).

This 2-year study demonstrates anew that Doxium® prevents capillary retinal leakage and confirms the clinical efficacy observed in previous and generally shorter trials conducted in diabetic patients.