Lower is better: BPROAD trial backs intensive blood pressure target for patients with diabetes
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Key takeaways:
- Incidence of major CV events was lower with treatment targeting systolic BP less than 120 mm Hg vs. 140 mm Hg in patients with diabetes.
- Hypotension and hyperkalemia rates were higher with intensive treatment.
CHICAGO — An intensive blood pressure strategy resulted in a lower incidence of major cardiovascular events compared with a more standard strategy among patients with type 2 diabetes and elevated systolic blood pressure in the BPROAD trial.
The BPROAD trial aimed to determine the optimal systolic BP control target for patients with type 2 diabetes. To date, other trials that examined this — like ACCORD BP and SPRINT, in patients with and without diabetes — have generated differing results.
“The BPROAD study just filled a key gap in our knowledge about lower blood pressure, particularly if this concept applies to patients with diabetes, and the answer is definitively yes. Now, we have to work toward implementing these important findings in the millions of individuals worldwide with diabetes,” Amit Khera, MD, American Heart Association 2024 program chair and the Dallas Heart Ball Chair in Hypertension and Heart Disease, professor of internal medicine and director of preventive cardiology at UT Southwestern Medical Center, said during a press conference discussion of the results.
The BPROAD trial included patients with type 2 diabetes, elevated systolic BP and increased risk for CVD, enrolled at 145 sites in China. Nearly half were women (45.3%) and the mean age was 64 years. Twenty-two percent of patients had a history of clinical CVD at baseline. Each patient underwent random assignment to intensive BP treatment, with a target systolic BP of less than 120 mm Hg, or standard treatment, with a target systolic BP of less than 140 mm Hg, for up to 5 years. Treatment choice and doses of antihypertensive medications was flexible, but preferences were based on CVD outcome trial results and current clinical guidelines, Guang Ning, MD, PhD, elected member of the Chinese Academy of Engineering and professor at Ruijin Hospital at Shanghai Jiao Tong University School of Medicine, China, said during the late-breaking clinical trial presentation at the AHA Scientific Sessions.
The results were presented here and simultaneously published in The New England Journal of Medicine.
Differences in the incidence of major CVD events
Baseline mean systolic BP level was 140 mm Hg. Systolic BP levels declined rapidly in both groups after the intervention, Ning said. At 1-year follow-up, mean systolic BP was 121.6 mm Hg (median, 118.3) in the intensive-treatment group compared with 133.2 mm Hg (median, 135) in the standard-treatment group, according to the results. This difference in systolic BP levels continued during follow-up, Ning said during the late-breaking clinical trial presentation.
During the median follow-up of 4.2 years, the primary outcome — which comprised nonfatal stroke, nonfatal MI, treatment or hospitalization for HF or death from CV causes — occurred in 393 patients (1.65% per year) in the intensive-treatment group compared with 492 patients (2.09% per year) in the standard-treatment group (HR = 0.79; 95% CI, 0.69-0.9; P < .001), Ning said.
“The BPROAD study revealed that in patients with type 2 diabetes and elevated CVD risk, intensive treatment targeting systolic BP less than 120 mm Hg resulted in a lower incidence of major CVD events as compared with standard treatment targeting systolic BP less than 140 mm Hg,” Ning said during the presentation. “Our findings are consistent with findings from the SPRINT study in hypertension patients without diabetes.”
The benefits observed with intensive BP treatment were consistent across prespecified subgroups, Ning said.
Serious adverse events were similar in both groups. However, symptomatic hypotension (0.12% vs. 0.02%; P < .05) and hyperkalemia (2.84% vs. 2.01%; P = .003) occurred more frequently in the intensive-treatment group.
‘Consistent evidence’
The BPROAD trial provides “consistent evidence that lowering BP to less than 120 mm Hg reduces outcomes” in this patient population and “now confirms that diabetics ... have the same response as nondiabetics in terms of blood pressure treatments,” Shawna Nesbitt, MD, MS, professor of internal medicine and cardiology and chief institutional opportunity officer at UT Southwestern Medical Center, said during the press conference discussion.
However, “patient age and condition must be considered as you are deciding how low the BP should go, as we know that in elderly people the likelihood of having a fall or having hypotension may be slightly increased,” Nesbitt said. “We must be careful to monitor [serious adverse events] as we treat our patients with BP therapy.”
During a discussion after the late-breaking clinical trial results, Dorairaj Prabhakaran, MD, DM, MSc, executive director at the Centre for Chronic Disease Control in New Delhi, said this trial was important to conduct because there are approximately 828 million adults with diabetes worldwide and about half of those are untreated.
The optimal BP target in patients with diabetes has been “debatable,” and differences among guidelines on the target BP have led to “quite a bit of confusion” among clinicians, Prabhakaran said. Moreover, there has been “true equipoise” after the ACCORD, ADVANCE and SPRINT trials, he said.
Looking ahead, Prabhakaran said it will be important to question how to generalize and translate the BPROAD trial to other countries and contexts.
Reference:
Perspective
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We have known for a long time that intensive BP lowering is probably superior in terms of reducing CV endpoints. We have seen a series of studies that have come out recently that have persuaded, for example, the American College of Cardiology to recommend a systolic BP target of less than 130 mm Hg, and that is a result of now having many studies that show that the direction of improving clinical outcomes is with more intensive BP lowering. This study adds to the existing literature that shows that intensive BP lowering is probably beneficial.
In the SPRINT trial, they excluded patients who had stroke and diabetes, because the ACCORD trial previously suggested that maybe there was a signal toward no improvement with intensive BP treatment. Of note, there are a lot of differences between these trials. BPROAD was a Chinese population, specifically, which is sort of the opposite of the population in the other studies like ACCORD and SPRINT. This study adds to the literature in that now we have multiple randomized clinical trials showing that intensive BP treatment is beneficial. A challenge is the lack of concordance in clinical guidelines and recommendations has been problematic. The European guideline published a few months ago is more consistent, even though they do not change the definition or the classification, but the recommendation for the target is similar to the U.S. guideline, at least the current form.
Where we have gaps still is with primary care. The primary care guidelines still endorse a more lenient target in general of less than 140/90 mm Hg, instead of less than 130/80 mm Hg. It is possible that with this study, in combination with other studies, will perhaps get primary care physicians to appreciate that we need to have more consistency across all the guidelines.
Ultimately, what we know we need is better BP control.
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Ning G. LBS.01. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2024; Chicago.
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