Intensive treatment to control systolic blood pressure (BP) to less than 120 mmHg significantly reduced the incidence of major cardiovascular events in patients over the age of 50 with type 2 diabetes, based on results from the BPROAD trial presented at AHA 2024 and simultaneously published in NEJM.

Researchers randomly assigned 12,821 patients from 145 sites in China, all of whom had elevated systolic BP, an increased risk of cardiovascular disease and type 2 diabetes, to receive either intensive treatment controlling systolic BP at less than 120 mmHg (n=6,414) or standard treatment targeting a systolic BP of less than 140 mmHg (n=6,407) for five years. The mean age was 64 and approximately 45% were women. In this study, the criteria for elevated systolic BP was ≥140 mmHg without antihypertensive medications or ≥130 mmHg and taking at least one anti-hypertensive medication.

The primary outcome – a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes – 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) over the roughly five years of follow-up. Researchers highlighted no significant differences in the incidence of serious adverse events between the two groups, however they said that symptomatic hypotension and hyperkalemia were more frequently observed among patients in the intensive-treatment group than those receiving standard-treatment. At one year of follow-up, the mean systolic BP was 121.6 mmHg (median, 118.3 mmHg) in the intensive-treatment group compared with 133.2 mmHg (median, 135.0 mmHg) in the standard-treatment group.

"These findings provide strong support for a more intensive systolic BP target in people with type 2 diabetes for the prevention of major cardiovascular events," said lead study author Guang Ning, MD, PhD, FACC, a professor at Ruijin Hospital at Shanghai Jiao Tong University School of Medicine in Shanghai, China.

According to Ning, the study results are consistent with another study of patients with hypertension but without diabetes, which found a significantly 27% reduction in the incidence of cardiovascular diseases. "Future clinical practice guidelines will hopefully consider these results when making recommendations for BP targets for people with type 2 diabetes," he said. "Beneficial future research could focus on profiling those with the largest benefit and the lowest harm in an intensive BP treatment group."

There were several limitations to the study, including the marked difference in diastolic BP between groups, which could impact "the independent effect of systolic BP on trial outcomes." Additionally, the findings may not be generalizable to people of other ethnic populations or to populations with characteristics different from the participants, researchers said.