Efficacy and safety of intensive versus standard systolic blood pressure treatment: A systematic review and meta-analysis
O Rueda Ochoa, Y C Mayorga Parra, J A Laguna DuarteAbstract
Background/Introduction
Hypertension is a major cardiovascular risk factor. While SPRINT supported systolic blood pressure (SBP) <120 mmHg, ACCORD showed no similar benefit in diabetes. Recent trials raised safety concerns, leaving optimal SBP targets and the benefit-harm balance uncertain.
Purpose
To evaluate the efficacy and safety of intensive versus standard SBP targets for major adverse cardiovascular events (MACE) and serious adverse events (SAE), including in diabetic patients.
Methods
This PRISMA/PROSPERO systematic review searched five databases up to Jan 2026. We included 12 trials. Bias was assessed via Cochrane RoB 2. Random-effects meta-analyses estimated risk ratios (RR) with 95% confidence and prediction intervals (PI). Risk differences and numbers needed to harm (NNH) were calculated for SAEs. Analyses used Stata 19.0.
Results
Across 12 trials (50,070 patients; follow-up 2.0–4.7 years), intensive SBP control reduced MACE (RR 0.82; 95% CI 0.77–0.87; I²=40.9%; post-sensitivity RR 0.81; 0.76–0.87; I²=16.5%). Consistent reductions (I²≤13.0%) occurred in cardiovascular (CV) mortality (RR 0.71; 0.61–0.83), heart failure (RR 0.71; 0.61–0.83), myocardial infarction (MI) (RR 0.83; 0.73–0.94), and stroke (RR 0.80; 0.73–0.87), but not acute coronary syndrome (RR 0.93; 0.83–1.04). Benefit was independent of measurement method (automated vs. observed, p-int=0.646). Stroke decreased in diabetic (RR 0.72; 0.54–0.97) and non-diabetic (RR 0.82; 0.73–0.92) patients; however, MI (RR 0.80; 0.69–0.94) and CV mortality (RR 0.63; 0.52–0.76) reductions were exclusive to non-diabetics (p-int=0.641). Safety: intensive therapy increased hypotension (RR 2.34; 1.47–3.72; PI 0.91–5.99; NNH 94), renal failure (RR 1.67; 1.24–2.24; PI 1.08–2.58; NNH 240), syncope (RR 1.71; 1.28–2.28; PI 1.10–2.65; NNH 289), hyponatraemia (RR 1.44; 1.03–2.00; PI 0.81–2.56; NNH 184), and hypokalaemia (RR 1.30; 1.09–1.54). Overall SAEs (RR 1.01; 0.98–1.04; PI 0.98–1.04), arrhythmias (RR 1.13; 0.76–1.69), and falls (RR 0.98; 0.87–1.11) did not significantly increase.
Conclusion(s)
Intensive SBP targets offer substantial cardiovascular protection, mainly for non-diabetics, but require a clinical trade-off. While overall SAEs remain stable, elevated risks of hypotension, syncope, and renal failure mandate personalised, closely monitored treatment