medwireNews: Treating toward intensive targets for systolic blood pressure (BP) significantly lowers the risk for major cardiovascular events in people with type 2 diabetes, research shows.
The results of the BPROAD trial “provide support for more-intensive systolic blood-pressure control in patients with diabetes for the prevention of major cardiovascular disease events,” write Weiqing Wang (Shanghai Jiao Tong University School of Medicine, China) and co-authors in The New England Journal of Medicine.
The study, which was also presented at the AHA Scientific Sessions 2024 in Chicago, Illinois, USA, included 12,821 patients aged 50 years or older (mean age 64 years, 45% women) with type 2 diabetes, elevated systolic BP, and an increased risk for cardiovascular disease from 145 clinical sites across China between 2019 and 2021.
At baseline, the participants had a mean systolic BP of 140.0 mmHg. After 1 year, mean systolic BP was 121.6 mmHg in the 6414 individuals randomly assigned to receive intensive treatment that targeted a systolic BP of less than 120 mmHg. By comparison, it was 133.2 mmHg in the 6407 participants assigned to receive standard treatment that targeted a systolic BP of less than 140 mmHg.
Wang et al report that, during a median 4.2 years of follow-up, the primary composite outcome of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes occurred in 393 patients in the intensive-treatment group and 492 patients in the standard-treatment group, giving rates of 1.65 and 2.09 events per 100 person–years, respectively.
The difference between the two groups corresponded to a significant 21% lower risk for the composite outcome among the people given intensive treatment.
Among the individual components of the composite outcome, the risk for fatal or nonfatal stroke was a significant 21% lower in the intensive versus standard treatment group. The risk for the other components was also lower with intensive treatment but not significantly so.
In addition, intensive treatment was associated with a significant 13% reduction in the risk for incident albuminuria relative to standard treatment, but did not reduce the risk for the development or progression of chronic kidney disease, nor the risk for death from any cause.
Serious adverse events (AEs) occurred in 36.5% of patients in the intensive-treatment group and in 36.3% of those in the standard-treatment group. Most AEs of special interest, such as arrythmia, electrolyte abnormality, injurious falls, syncope, and acute renal failure, occurred at a similar rate between the two groups.
However, the authors note that the risk for symptomatic hypotension was a significant 7.9-fold higher with intensive versus standard BP therapy, with eight events occurring in 0.12% of patients versus one event in 0.016%, respectively. They therefore suggest that “with intensive blood-pressure targets, patients need to be monitored for hypotension, especially during the start of intensive blood-pressure reduction.”
Hyperkalemia was also significantly more common with intensive than standard treatment (2.8 vs 2.0%).
Wang and team conclude: “Our trial provided convincing evidence of the benefits of lowering systolic blood pressure to a target of less than 120 mmHg in patients with type 2 diabetes.”
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N Engl J Med 2024; doi:10.1056/NEJMoa2412006
AHA Scientific Sessions 2024; Chicago, Ilinois, USA: 16-18 November