Intensive Blood Pressure Control in Type 2 Diabetes: BPROAD Trial Summary

Background

Hypertension is the most modifiable cardiovascular risk factor in patients with type 2 diabetes. Yet, the ideal target for systolic blood pressure (SBP) remains a point of contention. Previous trials like ACCORD showed neutral findings for intensive BP lowering, whereas SPRINT—excluding patients with diabetes—showed clear benefits. The BPROAD trial aimed to resolve this uncertainty by evaluating whether targeting an SBP <120 mm Hg confers cardiovascular benefits over the standard <140 mm Hg in patients with type 2 diabetes.

Study Design

  • Trial Name: BPROAD (Blood Pressure Control Target in Diabetes)
  • ClinicalTrials.gov: NCT03808311
  • Journal: New England Journal of Medicine, March 2025
  • Study Period: 2019–2021
  • Sites: 145 centers across China
  • Design: Randomized, open-label, blinded endpoint assessment
  • Duration: Median 4.2 years follow-up

Inclusion Criteria

  • Age ≥50 years
  • Type 2 diabetes
  • Elevated SBP: 130–180 mm Hg (treated) or ≥140 mm Hg (untreated)
  • Increased cardiovascular risk (prior CVD, CKD, or multiple risk factors)

Interventions

  • Intensive group: SBP target <120 mm Hg
  • Standard group: SBP target <140 mm Hg
  • Antihypertensive regimens titrated per protocolized algorithms

Primary Outcome

Composite of:

  • Nonfatal stroke
  • Nonfatal myocardial infarction
  • Hospitalization or treatment for heart failure
  • Cardiovascular death

Key Findings

Blood Pressure Control

Time Point Intensive SBP (mean) Standard SBP (mean)
1 year 121.6 mm Hg 133.2 mm Hg

Cardiovascular Outcomes

Outcome Intensive Group Standard Group Hazard Ratio (95% CI) p-value
Primary composite endpoint 1.65/100 PY 2.09/100 PY 0.79 (0.69–0.90) <0.001
Fatal or nonfatal stroke 1.19/100 PY 1.50/100 PY 0.79 (0.67–0.92)
Heart failure hospitalization 0.13/100 PY 0.19/100 PY 0.66 (0.41–1.04)
Cardiovascular death 0.24/100 PY 0.32/100 PY 0.76 (0.55–1.06)
All-cause mortality 0.69/100 PY 0.73/100 PY 0.95 (0.77–1.17)

PY = person-years

Safety Outcomes

Adverse Event Intensive Group Standard Group Notable Findings
Serious AEs 36.5% 36.3% No significant difference
Symptomatic hypotension 0.1% <0.1% Slightly more frequent in intensive arm
Hyperkalemia (>5.5 mmol/L) 2.8% 2.0% Statistically significant (p = 0.003)

Conclusions

Intensive blood pressure control (target SBP <120 mm Hg) significantly reduced the incidence of major cardiovascular events compared to standard control (<140 mm Hg) in patients with T2DM. Benefits were consistent across subgroups and came without an overall increase in serious adverse events—though hypotension and hyperkalemia were more common with intensive therapy.

Clinical Perspective

  • Reinforces a shift toward more intensive BP targets in diabetes, aligning with SPRINT’s findings in non-diabetic populations.
  • Impacts guideline interpretations, potentially challenging the legacy of JNC 8.
  • Clinical implementation should weigh cardiovascular benefits against potential risks like electrolyte abnormalities and orthostatic events, especially in frail or elderly populations.

Reference

Bi Y, Li M, Liu Y, et al. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025;392(12):1155-1167. doi:10.1056/NEJMoa2412006(https://doi.org/10.1056/NEJMoa2412006)

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