Blood Pressure Control Target in Diabetes - BPROAD

Nov 16, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Anthony A. Bavry, MD,MPH,FACC
Trial Sponsor:
National Key Research and Development Program of the Ministry of Science and Technology of China
Date Presented:
11/16/2024
Date Published:
11/16/2024
Date Updated:
11/16/2024
Original Posted Date:
11/16/2024
References

Contribution To Literature:

The BPROAD trial showed that in patients with type 2 diabetes and hypertension with elevated CV risk, intensive treatment targeting SBP ≤120 mm Hg reduced the incidence of MACE at 5 years compared with standard treatment targeting ≤140 mm Hg.

Description:

The goal of the trial was to determine the efficacy and safety of an intensive blood pressure (BP)-lowering strategy in patients with type 2 diabetes mellitus (T2DM) and hypertension with respect to future cardiovascular disease (CVD) events.

Study Design

  • Multicenter (China)
  • Randomized
  • Assessor-blinded

Patients with T2DM and hypertension were randomized in a 1:1 fashion to intensive (n = 6,414) or standard (n = 6,407) antihypertensive therapy targeting a systolic blood pressure (SBP) of <120 or 140 mm Hg, respectively. Medications were adjusted at monthly visits following randomization until SBP goal was reached. Antihypertensive agent recommendations followed the 2018 Chinese guidelines but were ultimately at the clinicians’ discretion.

  • Total number of enrollees: 12,821
  • Duration of follow-up: 5 years
  • Mean patient age: 64 years
  • Percentage female: 45%

Inclusion criteria:

  • Age ≥50 years
  • T2DM: prior diagnosis and on medical therapy, fasting plasma glucose ≥126 mg/dL, glucose tolerance test 2-hour plasma glucose >200 mg/dL, or glycated hemoglobin (HbA1c) ≥6.5%
  • SBP ≥140 mm Hg untreated or ≥130 mm Hg treated
  • ≥1 additional risk factor: prior CVD (e.g., myocardial infarction [MI] or stroke) ≥3 months prior, subclinical CVD (e.g., microalbuminuria or coronary artery calcium score ≥400 AU) ≤3 years prior, ≥2 CVD risk factors (e.g., cigarette smoking or body mass index ≥28 kg/m2), or estimated glomerular filtration rate (eGFR) 30-59 mL/min/1.73 m2

Exclusion criteria:

  • Type 1 diabetes
  • Secondary hypertension
  • CVD event ≤3 months prior
  • Symptomatic heart failure (HF) or left ventricular ejection fraction <35% ≤6 months prior
  • eGFR <30 mL/min/1.73 m2

Other salient features/characteristics:

  • Mean HbA1c: 7.6%
  • Mean SBP at randomization: 140 mm Hg
  • Prior clinical CVD: 23%
  • Concurrent statin use: 65%

Principal Findings:

The primary outcome, composite of nonfatal stroke or MI, HF treatment or hospitalization, or CV death, for intensive vs. standard treatment at 5 years, was: 1.65% vs. 2.09% per year (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.69-0.90), p < 0.001.

Secondary outcomes for intensive vs. standard treatment at 5 years:

  • CV death: 0.24% vs. 0.32% per year (HR 0.76, 95% CI 0.55-1.06)
  • Fatal or nonfatal MI: 0.28% vs. 0.33% per year (HR 0.84, 95% CI 0.60-1.16)
  • Fatal or nonfatal stroke: 1.19% vs. 1.50% per year (HR 0.79, 95% CI 0.67-0.92)
  • HF treatment or hospitalization: 0.13% vs. 0.19% per year (HR 0.66, 95% CI 0.41-1.04)

Median SBP at 1 year for intensive vs. standard treatment was 118 vs. 135 mm Hg.

Adverse events for intensive vs. standard treatment:

  • Any serious adverse event: 36% vs. 36%, p = 0.96
  • Symptomatic hypotension: 0.1% vs. 0.02%, p = 0.05
  • Syncope: 0.2% vs. 0.2%, p = 0.99
  • Acute kidney injury: 0.06% vs. 0.08%, p = 0.73
  • Serum potassium >5.5 mmol/L: 2.8% vs. 2.0%, p = 0.003

Interpretation:

The ACCORD BP trial previously failed to demonstrate a CVD benefit to targeting SBP <120 mm Hg in T2DM but may have been underpowered for the observed event rate. Moreover, SPRINT did subsequently show a CVD reduction in patients without diabetes but with other risk factors, as did ESPRIT overall and in the diabetes subgroup. In the BPROAD trial, intensive treatment to SBP ≤120 mm Hg reduced CVD risk compared with a conventional target of ≤140 mm Hg. Symptomatic hypotension and elevated serum potassium were only slightly more frequent in the intensive treatment arm and could be easily managed by adjustment of drug therapy for individual patients. Of note, patients in BPROAD exhibited overall better glycemic control compared with the ACCORD BP cohort, in which a subgroup analysis suggested a differential treatment benefit in patients with HbA1c ≤8.0%. It is possible that the CVD risk of poorly controlled diabetes tempers any potential benefit of intensive antihypertensive therapy. The current data lend support to a more aggressive SBP target in diabetes and hypertension and warrant further study in non-Chinese cohorts to confirm generalizability across populations.

References:

Bi Y, Li M, Liu Y, et al., for the BPROAD Research Group. Intensive Blood-Pressure Control in Patients With Type 2 Diabetes. N Engl J Med 2024;Nov 16:[Epub ahead of print].

Presented by Dr. Guang Ning at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2024.

Clinical Topics: Prevention, Hypertension, Diabetes and Cardiometabolic Disease

Keywords: Antihypertensive Agents, Diabetes Mellitus, Type 2, Hypertension, AHA24, AHA Annual Scientific Sessions


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