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Press Releases

Data from the DIRECT Programme show that candesartan has effect on incidence and regression of diabetic retinopathy

New data from the DIRECT (DIabetic REtinopathy Candesartan Trials) study programme show that candesartan, an angiotensin receptor blocker (ARB), had a beneficial effect on the incidence of diabetic retinopathy in Type 1 diabetic patients and on the regression of retinopathy in Type 2 diabetic patients, despite the programme not reaching its primary endpoints. 

DIRECT is the first large-scale global programme examining the effect of an ARB, candesartan, on the onset and progression of diabetic retinopathy in over 5,000 Type 1 and Type 2 diabetic patients, with a particular focus on the early stages of the disease.

Results showed that in Type 1 patients with no signs of diabetic retinopathy at baseline, candesartan caused an 18% reduction in the incidence of diabetic retinopathy as measured by 2-step change on the Early Treatment of Diabetic Retinopathy Study (ETDRS) * scale (primary endpoint, p=0.0508), but a 35% reduction for a 3-step change (post-hoc analysis, p=0.003).¹
Treatment with candesartan also nonsignificantly reduced the risk of progression of retinopathy by 13% over placebo in Type 2 diabetes patients (primary endpoint, p=0.2).¹ Importantly, candesartan increased the probability of regression of retinopathy by 34% compared with placebo (pre-defined secondary endpoint, p=0.009).¹
Further, patients treated with candesartan were more likely to experience a significant overall change in retinopathy to more favourable levels by the end of the programme.¹

DIRECT was an international study programme across 309 centres in 30 countries which followed 5,231 patients for at least four years.  The programme comprised of three double blind, randomised, placebo controlled studies. ‘DIRECT-Prevent 1’ studied the effect of candesartan on the incidence of new retinopathy (primary endpoint) in normotensive, normoalbuminuric Type 1 diabetic patients; ‘DIRECT-Protect 1’ studied the effect of candesartan on the progression of retinopathy (primary endpoint) in normotensive, normoalbuminuric Type 1 diabetic patients already affected by retinopathy; ‘DIRECT-Protect 2’ studied the effect of candesartan on the progression of retinopathy (primary endpoint) in normoalbuminuric, normotensive or treated hypertensive, Type 2 diabetic patients with retinopathy. The primary endpoints were measured as a predefined change in the ETDRS scale for retinopathy in each of the three studies.

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