OBJECTIVE: To determine whether tight control of blood pressure prevents macrovascular and microvascular complications in patients with type 2 diabetes.
DESIGN: Randomised controlled trial comparing tight control of blood pressure aiming at a blood pressure of <150/85 mm Hg (with the use of an angiotensin converting enzyme inhibitor captopril or a beta blocker atenolol as main treatment) with less tight control aiming at a blood pressure of <180/105 mm Hg.
SETTING: 20 hospital based clinics in England， Scotland， and Northern Ireland.
SUBJECTS: 1148 hypertensive patients with type 2 diabetes (mean age 56， mean blood pressure at entry 160/94 mm Hg); 758 patients were allocated to tight control of blood pressure and 390 patients to less tight control with a median follow up of 8.4 years.
MAIN OUTCOME MEASURES: Predefined clinical end points， fatal and non-fatal， related to diabetes， deaths related to diabetes， and all cause mortality. Surrogate measures of microvascular disease included urinary albumin excretion and retinal photography.
RESULTS: Mean blood pressure during follow up was significantly reduced in the group assigned tight blood pressure control (144/82 mm Hg) compared with the group assigned to less tight control (154/87 mm Hg) (P<0.0001). Reductions in risk in the group assigned to tight control compared with that assigned to less tight control were 24% in diabetes related end points (95% confidence interval 8% to 38%) (P=0.0046)， 32% in deaths related to diabetes (6% to 51%) (P=0.019)， 44% in strokes (11% to 65%) (P=0.013)， and 37% in microvascular end points (11% to 56%) (P=0.0092)， predominantly owing to a reduced risk of retinal photocoagulation. There was a non-significant reduction in all cause mortality. After nine years of follow up the group assigned to tight blood pressure control also had a 34% reduction in risk in the proportion of patients with deterioration of retinopathy by two steps (99% confidence interval 11% to 50%) (P=0.0004) and a 47% reduced risk (7% to 70%) (P=0.004) of deterioration in visual acuity by three lines of the early treatment of diabetic retinopathy study (ETDRS) chart. After nine years of follow up 29% of patients in the group assigned to tight control required three or more treatments to lower blood pressure to achieve target blood pressures.
CONCLUSION: Tight blood pressure control in patients with hypertension and type 2 diabetes achieves a clinically important reduction in the risk of deaths related to diabetes， complications related to diabetes， progression of diabetic retinopathy， and deterioration in visual acuity.
BMJ. 1998 Sep 12;317(7160):703-13.