BACKGROUND
Effective targets for systolic blood-pressure control in patients with type 2 diabetes
are unclear.
METHODS
We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic
blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites
across China. Patients were randomly assigned to receive intensive treatment that
targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that
targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The
primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarc-
tion, treatment or hospitalization for heart failure, or death from cardiovascular
causes. Multiple imputation was used for missing outcome data, with an assumption
that the data were missing at random.
RESULTS
Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the
standard-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, 135.0
mm 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) in
the 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, 0.69
to 0.90; P<0.001). The incidence of serious adverse events was similar in the treat-
ment groups. However, symptomatic hypotension and hyperkalemia occurred more
frequently in the intensive-treatment group than in the standard-treatment group.
CONCLUSIONS
Among patients with type 2 diabetes, the incidence of major cardiovascular events
was significantly lower with intensive treatment targeting a systolic blood pressure
of less than 120 mm Hg than with standard treatment targeting a systolic blood
pressure 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.)
