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UKPDS 69

UK Prospective Diabetes Study (UKPDS) Group^*

Arch Ophthalmol. 2004;122:1631-1640.

Objective  To determine the relationship between tight blood pressure (BP) control and the different aspects of diabetic retinopathy in patients with type 2 diabetes mellitus (DM).

Setting  Nineteen hospital-based clinics in England, Scotland, and Northern Ireland.

Design  Outcome of retinopathy status assessed by 4-field retinal photography related to allocation within a randomized controlled trial comparing a tight BP control policy aiming for a BP less than 150/85 mm Hg with a less tight BP control policy aiming for a BP less than 180/105 mm Hg.

Subjects  One thousand one hundred forty-eight hypertensive patients with type 2 DM were studied. These patients had type 2 DM for a mean duration of 2.6 years at the inception of the Hypertension in Diabetes Study, had a mean age of 56 years; and had a mean BP of 160/94 mm Hg. Seven hundred fifty-eight patients were allocated to a tight BP control policy with angiotensin-converting enzyme inhibitor or -blockers as the main therapy; 390 were allocated to a less tight BP control policy.

Main Outcome Measures  Deterioration of retinopathy (2-step change on a modified Early Treatment Diabetic Retinopathy Study [ETDRS] final scale), together with end points (photocoagulation, vitreous hemorrhage, and cataract extraction) and analysis of specific lesions (microaneurysms, hard exudates, and cotton-wool spots). Visual acuity was assessed at 3-year intervals using ETDRS logarithm of the minimum angle of resolution charts. Blindness was monitored as an end point with the criterion of Snellen chart assessment at 6/60 or worse.

Results  By 4.5 years after randomization, there was a highly significant difference in microaneurysm count with 23.3% in the tight BP control group and 33.5% in the less tight BP control group having 5 or more microaneurysms (relative risk [RR], 0.70; P = .003). The effect continued to 7.5 years (RR, 0.66; P<.001). Hard exudates increased from a prevalence of 11.2% to 18.3% at 7.5 years after randomization with fewer lesions found in the tight BP control group (RR, 0.53; P<.001). Cotton-wool spots increased in both groups but less so in the tight BP control group which had fewer cotton-wool spots at 7.5 years (RR, 0.53; P<.001). A 2-step or more deterioration on the ETDRS scale was significantly different at 4.5 years with fewer people in the tight BP control group progressing 2 steps or more (RR, 0.75; P = .02). Patients allocated to tight BP control were less likely to undergo photocoagulation (RR, 0.65; P = .03). This difference was driven by a difference in photocoagulation due to maculopathy (RR, 0.58; P = .02). The cumulative incidence of the end point of blindness (Snellen visual acuity, 6/60) in 1 eye was 18/758 for the tight BP control group compared with 12/390 for less tight BP control group. These equate to absolute risks of 3.1 to 4.1 per 1000 patient-years, respectively (P = .046; RR, 0.76; 99% confidence interval, 0.29-1.99). There was no detectable difference in outcome between the 2 randomized therapies of angiotensin-converting enzyme inhibition and -blockade.

Conclusions  High BP is detrimental to each aspect of diabetic retinopathy; a tight BP control policy reduces the risk of clinical complications from diabetic eye disease.

*Authors: This report was prepared on behalf of the UKPDS by David R. Matthews, FRCP; Irene M. Stratton, BS, MSc; Stephen J. Aldington, DMS; Rury R. Holman, FRCP; Eva M. Kohner, FRCP.
Group Information: A list of the UKPDS Group as of September 17, 2004, was published in Lancet. 1998;352:837-853.

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