BPROAD
Trial question
What is the role of intensive BP control in patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 12821
12821 patients (5803 female, 7018 male).
Inclusion criteria: adult patients aged ≥ 50 years with T2DM, elevated SBP, and increased CVD risk.
Key exclusion criteria: T1DM; secondary hypertension; 1-minute standing SBP < 110 mmHg; cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months; symptomatic HF or LVEF < 35% within the past 6 months; proteinuria.
Interventions
N=6414 intensive treatment (target of SBP < 120 mmHg for up to 5 years).
N=6407 standard treatment (target of SBP < 140 mmHg for up to 5 years).
Primary outcome
Incidence of nonfatal stroke, nonfatal MI, treatment or hospitalization for heart failure, or CV death
1.65
2.09
2.1/100 py
1.6/100 py
1.0/100 py
0.5/100 py
0.0/100 py
Intensive
treatment
Standard
treatment
Significant
decrease ▼
Significant decrease in the incidence of nonfatal stroke, nonfatal MI, treatment or hospitalization for HF, or CV death (1.65 events /100 py vs. 2.09 events /100 py; HR 0.79, 95% CI 0.69 to 0.9).
Secondary outcomes
No significant difference in the incidence of fatal or nonfatal MI (0.28/100 py vs. 0.33/100 py; HR 0.84, 95% CI 0.6 to 1.16).
Significant decrease in the incidence of fatal or nonfatal stroke (1.19/100 py vs. 1.5/100 py; HR 0.79, 95% CI 0.67 to 0.92).
No significant difference in the incidence of death from any cause (0.69/100 py vs. 0.73/100 py; HR 0.95, 95% CI 0.77 to 1.17).
Safety outcomes
No significant difference in serious adverse events.
Significant differences in symptomatic hypotension (0.1% vs. < 0.1%), high serum potassium levels (2.8% vs. 2.0%).
Conclusion
In adult patients aged ≥ 50 years with T2DM, elevated SBP, and increased CVD risk, intensive treatment was superior to standard treatment with respect to the incidence of nonfatal stroke, nonfatal MI, treatment or hospitalization for HF, or CV death.
Reference
Yufang Bi, Mian Li, Yan Liu et al. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025 Mar 27;392(12):1155-1167.
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