Candesartan Increases Regression of Retinopathy in Type 2 Diabetes, Reduces Incidence in Type 1 Diabetes

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Title: Candesartan Increases Regression of Retinopathy in Type 2 Diabetes, Reduces Incidence in Type 1 Diabetes
URL: http://www.pslgroup.com/dg/22D8D2.htm
Doctor's Guide
September 25, 2008

NEW YORK -- September 25, 2008 -- Treatment with candesartan can increase regression of retinopathy in type 2 diabetes and reduce incidence of retinopathy in type 1 diabetes, according to the results of 2 studies, published early online and in an upcoming edition of The Lancet.

In the first of the 2 articles, Nish Chaturvedi, National Heart and Lung Institute, Imperial College Healthcare NHS Trust London, London, United Kingdom, and colleagues examined the effect of candesartan on incidence and progression of retinopathy in type 1 diabetes.

This part of the study was formed by 2 randomised control trials: Diabetic Retinopathy Candesartan Trials (DIRECT)-Prevent 1 for patients without existing retinopathy and DIRECT-Protect 1 for patients who already had the condition.

In DIRECT-Prevent 1, 711 patients received candesartan and 710 patients received placebo. The researchers found that the incidence of retinopathy was 18% lower for patients given candesartan, a result with borderline statistical significance.

In DIRECT-Protect 1, 951 patients received candesartan and 954 placebo, with no statistically significant difference overall in retinopathy progression between the 2 groups.

However, further analysis revealed that risk of retinopathy progression by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was 35% lower for patients receiving candesartan compared with placebo.

Patients' final stage of retinopathy after the 4-year-long trial was more likely to have improved with candesartan compared with placebo in both DIRECT-Prevent 1 (by 16%) and in DIRECT-Protect 1 (by 12%).

"Although candesartan reduces the incidence of retinopathy, we did not see a beneficial effect on retinopathy progression," the authors wrote.

In the second study, Anne Sjølie, Odense University Hospital, Odense, Denmark, and colleagues report on the DIRECT-Protect 2 study -- a randomised controlled trial to analyse the effect of candesartan on both slowing progression and inducing regression of retinopathy in patients with type 2 diabetes.

The trial looked at 1,905 patients with mild to moderately severe retinopathy. Of the patients, 951 received candesartan 16 mg QD (doubled to 32 mg after 1 month) and 954 patients received placebo.

The researchers found that 17% of patients receiving candesartan and 19% of patients receiving placebo had progression of retinopathy by 3 or more steps on the ETDRS scale -- a nonstatistically significant risk reduction of 13% for candesartan patients. Egression was increased by 34% in the candesartan group compared with placebo.

Patients in the candesartan group were 17% more likely than placebo to experience an overall change towards less severe retinopathy by the end of the trial. "These results suggest that treatment with candesartan in type 2 diabetic patients with mild to moderate retinopathy could induce improvement of retinopathy," the authors wrote.

SOURCE: The Lancet

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