BROAD trial: Intensive Blood-Pressure Control in Patients with Type 2 Diabetes

BACKGROUNDEffective targets for systolic blood-pressure control in patients with type 2 diabetesare unclear.METHODSWe enrolled patients 50 years of age or older with type 2 diabetes, elevated systolicblood pressure, and an increased risk of cardiovascular disease at 145 clinical sitesacross China. Patients were randomly assigned to receive intensive treatment thattargeted a systolic blood pressure of less than 120 mm Hg or standard treatment thattargeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. Theprimary outcome was a composite of nonfatal stroke, nonfatal myocardial infarc-tion, treatment or hospitalization for heart failure, or death from cardiovascularcauses. Multiple imputation was used for missing outcome data, with an assumptionthat the data were missing at random.RESULTSOf 12,821 patients (6414 patients in the intensive-treatment group and 6407 in thestandard-treatment group) enrolled from February 2019 through December 2021,5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years.At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median,118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years,primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) inthe intensive-treatment group and 492 patients (2.09 events per 100 person-years)in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69to 0.90; P<0.001). The incidence of serious adverse events was similar in the treat-ment groups. However, symptomatic hypotension and hyperkalemia occurred morefrequently in the intensive-treatment group than in the standard-treatment group.CONCLUSIONSAmong patients with type 2 diabetes, the incidence of major cardiovascular eventswas significantly lower with intensive treatment targeting a systolic blood pressureof less than 120 mm Hg than with standard treatment targeting a systolic bloodpressure of less than 140 mm Hg. (Funded by the National Key Research and Devel-opment Program of the Ministry of Science and Technology of China and others;BPROAD ClinicalTrials.gov number, NCT03808311.)