Intensive Blood Pressure Control Benefits People With Type 2 Diabetes Too

CHICAGO — The cardiovascular outcome benefit of a tighter systolic blood pressure target was affirmed in patients with type 2 diabetes in the randomized BPROAD trial from China.

A target of less than 120 mm Hg reduced a composite of stroke, myocardial infarction, heart failure treatment or hospitalization, and cardiovascular death by a relative 21% compared with a target under 140 mm Hg during a median follow-up of 4.2 years, Guang Ning, MD, PhD, of Shanghai Jiao Tong University School of Medicine, reported at the American Heart Association (AHA) Scientific Sessions.

Mean achieved blood pressure in the two groups was 120.6 mm Hg in the intensive-treatment group and 132.1 mm Hg in the standard-management group. The difference translated to an absolute 0.44% lower risk per year (1.65 vs 2.09 events per 100 person-years, P<0.001) in the findings published concurrently in the New England Journal of Medicine.

Of all the endpoint components, stroke drove the primary endpoint difference. As a secondary endpoint, fatal or nonfatal stroke occurred 21% less often with intensive blood pressure lowering than with standard targets (1.19 vs 1.50 events per 100 person-years, HR 0.79, 95% CI 0.67-0.92).

Shawna Nesbitt, MD, of UT Southwestern Medical Center in Dallas and study discussant at an AHA press conference, drew comparisons to two prior trials comparing targets of less than 120 versus 140 mm Hg systolic: the ACCORD BP trial, which found a nonsignificant trend for lower cardiovascular event rates with intensive blood pressure control in type 2 diabetes, and the SPRINT trial, which found significant benefits in a non-diabetic population.

That combination of positive and negative findings “goes against what one would think,” said Nesbitt, “because the risk of cardiovascular events in diabetics is obviously much higher.”

She pointed to one potential explanation being the tiered enrollment design of ACCORD such that the less risky patients were reserved for the blood pressure arm of the two-by-two randomized trial.

“This trial now confirms that diabetics actually have the same response as non-diabetics in terms of blood pressure treatments,” she concluded.

John Buse, MD, PhD, an endocrinologist at the University of North Carolina at Chapel Hill and an ACCORD trial leader acknowledged the “several unsuccessful attempts to define a role for more stringent blood pressure control to reduce cardiovascular outcomes” in type 2 diabetes.

He agreed that BPROAD’s “demonstration of benefit of aiming for a systolic blood pressure less than 120 mm Hg from China is an important advance for evidence in this space.”

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 recommend 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 suggested that there should now be unification of the guidelines to the intensive target.

However, Buse sounded a note of caution: “One thing to keep in mind is that type 2 diabetes in China is quite different than the disease in the U.S., with much lesser burden of obesity and greater insulin deficiency. Whether this translates to people with type 2 diabetes in the U.S. is not certain.”

BPROAD included 12,821 patients (45.3% women) enrolled from February 2019 through December 2021 at 145 clinical sites across China. Inclusion criteria were age 50 or older (mean 63.8), type 2 diabetes, increased risk of cardiovascular disease, and a baseline systolic blood pressure of 130-180 mm Hg while taking antihypertensive medications or at least 140 mm Hg while not taking antihypertensives.

Serious adverse event rates came out similar in the two groups overall, but symptomatic hypotension and hyperkalemia occurred more frequently with intensive treatment, as expected from the prior trials.

Nesbitt noted that the trial used the same protocol for blood pressure measurement and the same Omron devices as in the SPRINT trial. “In the SPRINT trial, I’ll point out that there was a publication that showed that whether or not [the measurements] were witnessed or not witnessed did not change the outcome of the trial. And so although there are still questions about exactly how blood pressure should be measured, the outcome was basically the same.”

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