A new study from China, the BPROAD trial, reveals that targeting a systolic blood pressure of less than 120 mm Hg can significantly reduce cardiovascular events in individuals with type 2 diabetes. The trial, presented at the American Heart Association (AHA) Scientific Sessions, showed a 21% relative reduction in a composite outcome of stroke, myocardial infarction, heart failure treatment or hospitalization, and cardiovascular death compared to a target of under 140 mm Hg.
The findings, led by Guang Ning, MD, PhD, of Shanghai Jiao Tong University School of Medicine, were simultaneously published in the New England Journal of Medicine. The study enrolled 12,821 patients across 145 clinical sites in China between February 2019 and December 2021. Participants were aged 50 or older, had type 2 diabetes, were at increased cardiovascular risk, and had a baseline systolic blood pressure of 130-180 mm Hg while on antihypertensive medications or at least 140 mm Hg while not taking antihypertensives. The median follow-up was 4.2 years.
Key Results from the BPROAD Trial
The intensive-treatment group achieved a mean blood pressure of 120.6 mm Hg, while the standard-management group reached 132.1 mm Hg. This difference translated to an absolute risk reduction of 0.44% per year (1.65 vs 2.09 events per 100 person-years, P < 0.001). Stroke was a significant contributor to the primary endpoint difference, with a 21% reduction in fatal or nonfatal stroke in the intensive blood pressure lowering group (1.19 vs 1.50 events per 100 person-years, HR 0.79, 95% CI 0.67-0.92).
Comparison to Prior Trials and Guidelines
Shawna Nesbitt, MD, of UT Southwestern Medical Center in Dallas, compared the BPROAD trial to the ACCORD BP and SPRINT trials. ACCORD BP showed a non-significant trend for lower cardiovascular event rates with intensive blood pressure control in type 2 diabetes, while SPRINT demonstrated significant benefits in a non-diabetic population. Nesbitt noted that the BPROAD trial confirms that diabetics respond similarly to non-diabetics in terms of blood pressure treatments.
Current AHA/American College of Cardiology guidelines recommend a systolic blood pressure target of less than 130/80 mm Hg for adults with diabetes, while American Diabetes Association guidelines suggest a goal under 140/90 mm Hg for most patients with diabetes but the under 130/80 mm Hg threshold for those at higher cardiovascular risk. Ning advocated for unifying the guidelines to the more intensive target.
Considerations and Cautions
John Buse, MD, PhD, an endocrinologist at the University of North Carolina at Chapel Hill and an ACCORD trial leader, acknowledged previous unsuccessful attempts to define a role for more stringent blood pressure control in type 2 diabetes. He cautioned that type 2 diabetes in China differs from that in the U.S., with a lesser burden of obesity and greater insulin deficiency, which may affect the applicability of the findings to the U.S. population.
While serious adverse event rates were similar between the two groups, symptomatic hypotension and hyperkalemia were more frequent with intensive treatment, consistent with prior trials. The trial utilized the same protocol for blood pressure measurement and the same Omron devices as in the SPRINT trial, addressing concerns about measurement accuracy.
