Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus
Why the study?
The optimal blood pressure goal in patients with diabetes mellitus remains controversial, and whether baseline blood pressure or cardiovascular disease risk influences the benefits and risks of intensified antihypertensive therapy is uncertain.
Does combination perindopril-indapamide reduce mortality and major vascular events in patients with type 2 diabetes mellitus at moderate-to-high cardiovascular risk, regardless of baseline blood pressure?
Population
10 948 people with diabetes mellitus at moderate-to-high risk in the ADVANCE trial
Comparison
Combination perindopril-indapamide treatment vs placebo
Design
Randomized trial post-hoc analysis
Follow-up
4.3 years
Authors
Discussion
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Member takes
Implication
May support risk-stratified BP targets in diabetes; leaves open optimal thresholds pending dedicated trials.
Key Points
- To assess whether the clinical benefits and safety risks of intensified blood pressure lowering in type 2 diabetes mellitus vary according to baseline blood pressure or baseline cardiovascular disease risk.
- Evaluation of 10,948 moderate-to-high-risk individuals with diabetes mellitus randomized to combination perindopril-indapamide or placebo in the ADVANCE trial with 4.3 years of follow-up (NCT00751972).
- Cox proportional hazards models assessed whether baseline systolic BP (down to <120 mm Hg), diastolic BP (down to <70 mm Hg), or 10-year cardiovascular risk (≥20% vs <20%) modified treatment efficacy or adverse events.
- Perindopril-indapamide significantly reduced all-cause mortality and major macrovascular or microvascular events compared with placebo over 4.3 years.
- Treatment benefits were consistent regardless of baseline systolic BP (P for heterogeneity = 0.85), baseline diastolic BP (P = 0.49), or 10-year CVD risk (P = 0.08).
- Discontinuation of therapy due to cough, hypotension, or dizziness did not differ significantly across subgroups stratified by baseline blood pressure and cardiovascular risk (all P ≥ 0.08).
Structured PICO
Does combination perindopril-indapamide reduce mortality and major vascular events in patients with type 2 diabetes mellitus at moderate-to-high cardiovascular risk, regardless of baseline blood pressure?
P
Population
10,948 people with type 2 diabetes mellitus at moderate-to-high cardiovascular risk (from the ADVANCE trial)
I
Intervention
Combination perindopril-indapamide
C
Comparator
Placebo
O
Outcome
Mortality and major vascular (macrovascular or microvascular) eventshard clinical
Intensive blood pressure lowering with perindopril-indapamide benefits patients with type 2 diabetes regardless of baseline blood pressure or cardiovascular risk, challenging guidelines that restrict treatment based on these thresholds.
Cite This Study
Rahman et al. (2019) studied this question.