Key Points
- BPROAD was a randomized control trial in China that assigned nearly 13,000 participants
with type 2 diabetes (T2DM) and hypertension (HTN) to either a systolic blood pressure
target of 120mmHg (intensive arm) or 140mmHg (standard arm). - At 5 years of follow up, the intensive arm had significantly lower rates of major
cardiovascular events (MACE: a composite of heart attack, stroke, heart failure, and
cardiovascular death), however symptomatic hypotension and hyperkalemia occurred more frequently in the intensive arm. - This trial supports targeting a systolic blood pressure of<120 mmHg to prevent MACE
among patients with T2DM and HTN, with close monitoring for adverse effects.
Nearly 75% of patients with T2DM have high blood pressure. Hypertension is a major risk
factor for cardiovascular disease (CVD), including myocardial infarction, stroke, and heart
failure. While the SPRINT trial demonstrated that intensive blood pressure control improves
cardiovascular risk among those with HTN, patients with T2DM were excluded. 1 The ACCORD
BP trial found no benefit to an intensive blood pressure control strategy among those with
T2DM, however the power of this study was limited, and the interaction between intensive blood pressure control and intensive glycemic control strategies pursued in this study affected the overall results. 2 Therefore, benefit of intensive blood pressure control among those with T2DM remains uncertain.
On November 16, 2024 the results of Blood Pressure Control Target in Diabetes (BPROAD)
Study were presented at AHA Scientific Sessions 2024 with simultaneous publication in the New England Journal of Medicine. The purpose of this study was to determine whether targeting an intensive systolic blood pressure goal of <120 mmHg was more effective than the standard target of <140 mmHg in reducing the risk major cardiovascular adverse events (MACE) –including non-fatal stroke, myocardial infarction, heart failure, and cardiovascular death –among adults with T2DM.
BPROAD randomized 12,821 adults aged 50 or older with T2DM, HTN, and an increased risk of
CVD at 145 study sites across mainland China in 1:1 fashion to the intensive or standard
treatment arm. HTN for this study was defined as an systolic blood pressure of ≥ 140 mmHg on no medications or a systolic blood pressure of ≥130 mmHg on at least one medication. Increased CVD risk was defined as a history of clinical or subclinical cardiovascular disease prior to trial enrollment, at least two cardiovascular risk factors, or CKD. The average age was 64 years, 45% were women, and 23% self-reported a history of CVD. The groups were well balanced in terms of baseline characteristics, including blood pressure, BMI, smoking status, and hemoglobin A1c and lipid levels.
After 1 year of follow up, the mean systolic blood pressure in the intensive arm was 121.6
mmHg compared to 133.2 mmHg in the standard arm. At a median follow up for 4.2 years, rates of MACE were lower in the intensive arm (1.65 per 100 person-years) than in the standard arm (2.09 per 100 person-years), a significant reduction (HR 0.79 [95% CI 0.69-0.90]; p<0.001). The benefit of intensive control was consistent across the pre-specified subgroups. While the incidence of serious adverse events were similar, symptomatic hypotension and hyperkalemia was more frequent in the intensive arm.
Limitations of this study include lack of blinding for participants and study physicians, study
interruptions due to COVID-19 pandemic (the study enrolled from February 2019 through
December 2021), and limited generalizability to other populations.
Guang Ning, M.D., Ph.D., an elected member of the Chinese Academy of Engineering and a
professor at Ruijin Hospital at Shanghai Jiao Tong University School of Medicine in Shanghai,
China, concluded: “We found that for most people with Type 2 diabetes, lowering systolic blood pressure to less than 120 mm Hg reduced the risk of major cardiovascular events. These findings provide strong support for a more intensive systolic blood pressure target in people with Type 2 diabetes for the prevention of major cardiovascular events.”
References
1. The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-
Pressure Control. N Engl J Med. 2015;373(22):2103-2116. doi:10.1056/NEJMoa1511939
2. Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus. N Engl J Med.
2010;362(17):1575-1585. doi:10.1056/NEJMoa1001286