American Heart Association, 16 Nov, 2024 – Outcomes from the BPROAD (National Key R&D Program of China; NCT03808311) trial revealed that lowering high systolic blood pressure (SBP) with an intensive treatment strategy in patients with type 2 diabetes reduced the risk of major cardiovascular disease as opposed to a standard treatment strategy.
Just under 13,000 patients across China with high SBP, type 2 diabetes, and a history of or at high risk for cardiovascular disease were enrolled in the multicentre, open-label trial. Patients were randomized to receive intensive treatment with a low SBP target of <120 mmHg or standard treatment with a higher SBP target of <140 mmHg. Following randomization, medications were adjusted at monthly visits to achieve the SBP goals. While the antihypertensive agent recommendations followed the 2018 Chinese guidelines, the medications and dosages administered were at the clinicians' discretions. The primary endpoint was the time to the first occurrence of major adverse cardiovascular events (MACE), including non-fatal stroke, non-fatal myocardial infarction, hospitalized or treated heart failure, or cardiovascular death. The secondary endpoints included, but were not limited to, a composite of the primary outcome and all-cause mortality, macrovascular outcome, major coronary artery diseases, kidney outcomes, and cognitive function. The follow-up period was over five years.
The results presented by Prof Guang Ning (Shanghai Jiao Tong University, Shanghai, CN) demonstrated a 21% decreased risk of MACE in the intensive treatment group, with 393 events, as opposed to the standard treatment group, with 492 events (P<0.001). At four years, the mean SBP level lay at 120.6 mm Hg in the intensive treatment group and 132.1 mm Hg in the standard treatment group. For cardiovascular death alone, the percentage of occurrence in patients receiving intensive treatment was 0.24% verses 0.32% in those receiving standard treatment (HR 0.76). Additionally, the difference in any serious adverse events was nonsignificant (p = 0.96). However, high potassium levels of >5.5 mmol/L were more common in the intensive treatment group than the standard treatment group (2.8% vs 2.0%, p = 0.003), as well as symptomatic hypotension (0.1% vs 0.02%, p = 0.05).
Despite the study experiencing some limitations due to the COVID-19 pandemic, such as patients who were unable to visit the clinic having to self-report their SPB with standard home blood pressure monitoring, BPROAD suggests that intensive treatment strategies with a low SBP target of <120 mmHg are beneficial when managing patients with high SBP and type 2 diabetes.
Resources:
Clinical Trials. Blood Pressure Control Target in Diabetes (BPROAD). 2024. https://clinicaltrials.gov/study/NCT03808311 (accessed 4 December 2024).
American Heart Association. Systolic BP of less than 120 mm Hg reduced CVD risk in adults with Type 2 diabetes. Chicago: American Heart Association, 16 November 2024. https://newsroom.heart.org/news/systolic-bp-of-less-than-120-mm-hg-reduced-cvd-risk-in-adults-with-type-2-diabetes (accessed 4 December 2024).
Saha A. Blood Pressure Control Target in Diabetes – BPROAD. 2024. https://www.acc.org/latest-in-cardiology/clinical-trials/2024/11/15/15/09/bproad#:~:text=The%20BPROAD%20trial%20showed%20that,targeting%20≤140%20mm%20Hg (accessed 4 December 2024).
Bi Y, Li Mian, Liu Y, et al. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. The New England Journal of Medicine 2024. https://www.nejm.org/doi/abs/10.1056/NEJMoa2412006; DOI: 10.1056/NEJMoa2412006