In patients with type 2 diabetes, intensive blood-pressure control (targeting systolic BP <120 mm Hg) significantly reduced cardiovascular events compared to standard treatment (systolic BP <140 mm Hg), though it was associated with increased risks of symptomatic hypotension and hyperkalemia.
PICO Summary
Population:
12,821 patients aged ≥50 years with type 2 diabetes, elevated systolic BP (≥130 mm Hg on medication or ≥140 mm Hg untreated), and high cardiovascular risk.
Intervention:
Intensive treatment targeting systolic BP <120 mm Hg.
Comparison:
Standard treatment targeting systolic BP <140 mm Hg.
Outcome:
- Efficacy: Intensive treatment reduced composite primary outcomes (nonfatal stroke, nonfatal MI, heart failure hospitalisation, or cardiovascular death) with a hazard ratio (HR) of 0.79 (95% CI, 0.69–0.90; P < 0.001).
- Safety and Tolerability: Serious adverse events were similar between groups (36.5% vs. 36.3%). However, symptomatic hypotension (0.1% vs. <0.1%) and hyperkalemia (2.8% vs. 2.0%) were more frequent in the intensive-treatment group.
Clinical Summary
Main Finding:
Intensive systolic BP control (<120 mm Hg) significantly lowers cardiovascular event risks in type 2 diabetes, with consistent benefits across subgroups but elevated risks of some side effects.
Clinical Relevance:
This evidence reinforces the benefit of tighter BP control in high-risk diabetic patients to prevent major cardiovascular events. However, the increased risk of symptomatic hypotension and hyperkalemia highlights the importance of careful patient selection and monitoring, especially in older populations or those with advanced chronic kidney disease (CKD).
Study Overview:
- Type of Study: Randomised controlled trial (RCT).
- Sample Size & Population: 12,821 patients; mean age 63.8 years, 45.3% female.
- Intervention Duration & Doses: 4.2 years median follow-up; antihypertensive adjustments based on group BP targets.
- Comparison: Systolic BP <120 mm Hg vs. <140 mm Hg.
Outcomes:
- Primary Measure (Composite cardiovascular events): HR, 0.79 (95% CI, 0.69–0.90).
- Secondary Measure (Stroke incidence): HR, 0.79 (95% CI, 0.67–0.92).
- Safety Profile: Higher rates of symptomatic hypotension and hyperkalemia in the intensive group.
Expanded Clinical Outcomes:
1. Primary Outcome (Composite Cardiovascular Events):
Intensive BP control resulted in 1.65 events per 100 person-years compared to 2.09 events per 100 person-years in the standard group. This corresponds to a 21% relative reduction in major cardiovascular events (HR 0.79; 95% CI, 0.69–0.90; P < 0.001).
2. Stroke (Fatal or Nonfatal):
Stroke incidence was lower in the intensive group, with 1.19 events per 100 person-years compared to 1.50 in the standard group (HR 0.79; 95% CI, 0.67–0.92). Stroke prevention appeared to be a major driver of the benefit, consistent with hypertension’s role as a leading cause of stroke.
3. Heart Failure (Hospitalisation or Treatment):
The incidence of heart failure was reduced in the intensive group (0.13 vs. 0.19 events per 100 person-years), although the reduction was not statistically significant (HR 0.66; 95% CI, 0.41–1.04).
4. Cardiovascular Mortality:
Cardiovascular deaths were numerically lower in the intensive-treatment group (0.24 vs. 0.32 events per 100 person-years) but did not reach statistical significance (HR 0.76; 95% CI, 0.55–1.06).
5. All-Cause Mortality:
No significant difference was observed in all-cause mortality between the two groups (HR 0.95; 95% CI, 0.77–1.17).
6. Chronic Kidney Disease (CKD):
Similar rates of CKD progression and development were seen in both groups. However, incident albuminuria was less common in the intensive group (HR 0.87; 95% CI, 0.77–0.97).
7. Adverse Events:
Serious adverse events occurred at similar rates in both groups (36.5% in intensive vs. 36.3% in standard). Notable safety concerns included a higher frequency of:
• Symptomatic Hypotension: Reported in 0.1% of patients in the intensive group compared to <0.1% in the standard group (P = 0.05).
• Hyperkalemia: A serum potassium concentration >5.5 mmol/L occurred in 2.8% of intensive-treatment patients versus 2.0% in the standard group (P = 0.003).
Considerations:
Limitations include potential bias from unblinded treatment allocation and challenges with achieving target BP in ~40% of intensive-treatment participants. Findings may have limited generalisability to non-Asian populations or younger patients. Further studies are warranted to evaluate long-term outcomes and specific subgroup risks.
Reference:
Bi, Y., Li, M., Liu, Y., et al. (2024). “Intensive Blood-Pressure Control in Patients with Type 2 Diabetes.” New England Journal of Medicine. doi:10.1056/NEJMoa2412006
Disclosure:
This review was prepared with both human and AI assistance, and has been reviewed for accuracy, quality, and clarity.
