The effect of long-term treatment with sulindac on the progression of diabetic retinopathy.

OBJECTIVE

To evaluate the effects of long-term treatment with sulindac on the progression of diabetic retinopathy (DR).

RESEARCH DESIGN AND METHODS

40 Japanese patients with type 2 diabetes were enrolled in a randomized, single-blind controlled trial in which the effects of sulindac (200 mg/day, 100 mg twice a day; n = 16 patients) on the progression of DR were compared to controls (24 patients) for 3 years. All patients were comparable in their age, gender, duration of disease, body mass index, dipstick proteinuria, insulin therapy, glycemic control, and clinical stages of DR. Outcome was determined by comparing parameters of retinopathy in fundus photographs that were taken at time 0 to those taken 1, 2, and 3 years after the initiation of treatment.

RESULTS

Patients in the sulindac group did not develop DR during the course of treatment nor was there progression of pathology in those who began the study with mild non-proliferative DR (NPDR). On the other hand, six patients progressed to mild NPDR in the control group--three at year 1 and three at year 3--and an additional patient progressed to severe NPDR from mild NPDR by year 1 and to proliferative DR by year 2. The findings at year 3 in the sulindac group were significantly (p < 0.05) different from the control group. None of the patients experienced any adverse effects of treatment.

CONCLUSIONS

Long-term treatment with sulindac was clinically effective in decreasing the progression of mild DR in type 2 diabetic patients in this pilot study.