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Sulodeksyd – możliwości zastosowania u pacjentów z retinopatią cukrzycową
Sulodexide – the New Treatment Possibilities in Patients with Diabetic Retinopathy
Agnieszka Serwatka, Iwona Grabska-Liberek, Piotr Tesla
Oddział Kliniczny Okulistyki Centrum Medycznego Kształcenia Podyplomowego SPSK im. prof. W. Orłowskiego
Kierownik: prof. dr hab. n. med. Iwona Grabska-Liberek
Summary: Purpose: To present the multicenter trial which evaluate the effectiveness of sulodexide (Vessel Due F) for the treatment of hard exudates in non-proliferative diabetic retinopathy.
Methods: This was a randomized, placebo-controlled, double-masked multicenter trial involving 130 patients (65 for each group) who had mild-to-moderate non-proliferative diabetic retinopathy with macular hard exudates. Participants were given a daily dose of either 50.0 mg sulodexide or a matching dose of placebo orally for 12 months. Main outcome measure was an improvement in hard exudates 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 hard exudates severity than that shown by the placebo group (39.0% vs. 19.3%; chi square, P = 0.005). Sulodexide`s safety was comparable to that of the placebo.
Discussion: The trial recruited diabetes patients with only mild-to-moderate retinopathy and relatively good healthiness. Although an improvement in hard exudates was significantly greater in the sulodexide group compared to the control group, about 60% of patients receving sulodexide did not react to the treatment. Propably it might be the low dose of the study drug (other studies in diabetes patients used higher doses 100–400 mg per day). In the next part of the discussion we show other studies which evaluate the effectiveness of sulodexide in the treatment of ophthalmologic patients.
Conclusions: Oral sulodexide therapy over 12 months improved macular hard exudates in patients with mild-to moderate non-proliferative diabetic retinopathy without leading to detectable adverse events.
Słowa kluczowe: retinopatia cukrzycowa, sulodeksyd, wysięki twarde, terapia uzupełniająca.
Keywords: diabetic retinopathy, hard exudates, sulodexide, adjunctive treatment.