Effect of lisinopril on progression of retinopathy in normotensive people with type 1 diabetes

Background Retinopathy commonly occurs in people with type 1 diabetes. Strict glycaemic control can decrease development and progression of retinopathy only partially. Blood pressure is also a risk factor for microvascular complications. Antihypertensive therapy, especially with inhibitors of angiotensin-converting enzyme (ACE), can slow progression of nephropathy, but the effects on retinopathy have not been established. We investigated the effect of lisinopril on retinopathy in type 1 diabetes. Methods As part of a 2-year randomised double-blind placebo-controlled trial, we took retinal photographs at baseline and follow-up (24 months) in patients aged 20–59 in 15 European centres. Patients were not hypertensive, and were normoalbuminuric (85%) or microalbuminuric. Retinopathy was classified from photographs on a five-level scale (none to proliferative). Findings The proportion of patients with retinopathy at baseline was 65% (117) in the placebo group and 59% (103) in the lisinopril group (p=0•2). Patients on lisinopril had significantly lower HbA1c at baseline than those on placebo (6•9% vs 7•3 p=0•05). Retinopathy progressed by at least one level in 21 (13•2%) of 159 patients on lisinopril and 39 (23•4%) of 166 patients on placebo (odds ratio 0•50 [95% Cl 0•28–0•89], p=0•02). This 50% reduction was the same when adjusted for centre and glycaemic control (0•55 [0•30–1•03], p=0•06). Lisinopril also decreased progression by two or more grades (0•27 [0•07–1•00], p=0•05), and progression to proliferative retinopathy (0•18 [0•04–0•82], p=0•03). Progression was not associated with albuminuric status at baseline. Treatment reduced retinopathy incidence (0•69 [0•30–1•59], p=0•4). Interpretation Lisinopril may decrease retinopathy progression in non-hypertensive patients who have type 1 diabetes with little or no nephropathy. These findings need to be confirmed before changes to clinical practice can be advocated.