Effect of sulodexide in patients with non-proliferative diabetic retinopathy: diabetic retinopathy sulodexide study (DRESS)

Ji Hun Song, Hee Seung Chin, Oh Woong Kwon, Su Jin Lim, Ha Kyoung Kim, DRESS Research Group, Ji Hun Song, Hee Seung Chin, Oh Woong Kwon, Su Jin Lim, Ha Kyoung Kim, DRESS Research Group

Abstract

Purpose: To evaluate the effectiveness of sulodexide for the treatment of hard exudates (HE) in non-proliferative diabetic retinopathy (NPDR).

Methods: This was a randomized, placebo-controlled, multicenter trial involving 130 patients (65 for each group) who had mild-to-moderate NPDR with macular HE. Participants were given a daily dose of either 50 mg sulodexide or a matching dose of placebo orally for 12 months. Main outcome measure was an improvement in HE defined as a decrease in severity by at least two grades on a 10-grade severity scale. This was evaluated by fundus photography over 12-month period.

Results: The sulodexide group showed significantly greater improvement in HE severity than that shown by the placebo group (39.0 % vs. 19.3 %; chi square, P = 0.005). Logistic regression analysis yielded an odds ratio of 2.790 (95 % confidence interval, 1.155-6.743; P = 0.023) for the effect of treatment once adjustments were made for demographic, prognostic and disease confounders. Intention to treat and per-protocol analysis yielded similar results. Sulodexide's safety was comparable to that of the placebo.

Conclusions: Oral sulodexide therapy over 12 months improved macular HE in patients with mild-to-moderate NPDR, without leading to detectable adverse events. The study protocol was registered on clinicaltrial.gov under identifier NCT01295775.

Figures

Fig. 1
Fig. 1
The early treatment diabetic retinopathy study (ETDRS) standard photographs 3 (a) and 4 (b). From the Early Treatment Diabetic Retinopathy Study Research Group (1991); Grading diabetic retinopathy from stereoscopic color fundus photographs – an extension of the modified Airlie House classification. Ophthalmology 98:786–806. Reprinted courtesy of Elsevier
Fig. 2
Fig. 2
Typical examples of fundus photographs in each grade. a Grade 2. b Grade 3. c Grade 4a-. d Grade 4a. e Grade 4a+. f Grade 4b-. g Grade 4b. h Grade 4b+
Fig. 3
Fig. 3
Patients’ dispositions. ITT = intention to treat, PP = per protocol
Fig. 4
Fig. 4
Fundus photographs of two subjects in sulodexide group. a At T0, fundus photograph showed grouped hard exudates graded as 4b-. b Hard exudates gradually decreased to grade 3 at T6. c Further diminution of hard exudates attained grade 2 at T12. d Funds photograph of another subject revealed grouped hard exudates of grade 4b- at T0. e This patient also showed improvement in hard exudates to grade 4a at T6. f Further improvement continued to reach grade 3 at T12

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