Modest Effects of Intensive Blood Pressure–Lowering on Quality of Life in Patients at High Cardiovascular Risk: The ESPRIT Trial
Targeting SBP <120 mm Hg modestly improved HRQoL without harm. Multicenter open-label, blinded-outcome randomized controlled trial; Level 1b (2011 OCEBM).
Background
Whether more aggressive blood pressure lowering improves health-related quality of life (HRQoL) has been uncertain.
Patients
Hypertensive adults ≥50 years with high cardiovascular risk (prior stroke allowed); 10,804 analyzed (intensive n=5,398; standard n=5,406) from 11,255 randomized.
Intervention
Treat to office SBP <120 mm Hg.
Control
Treat to office SBP <140 mm Hg.
Outcome
Primary (HRQoL analysis): change in EQ-5D visual analog scale (VAS; 0–100; MCID=7 points). Secondary: proportion with meaningful improvement/worsening (≥7-point change), EQ-5D utility index, domain categories (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Follow up period
Median 3.36 years (IQR 3.04–3.44).
Results
| Outcome | Intensive | Standard | Effect (95% CI) | NNT/NNH |
|---|---|---|---|---|
| Primary: Change in EQ-5D VAS | +0.56 | −0.50 | Mean difference +1.26 (0.55 to 1.98) | NA |
| Clinically meaningful improvement (≥7 points) | 37.9% | 36.3% | RR 1.16 (1.04 to 1.30); ARR 1.6% | NNT 63 |
| Clinically meaningful worsening (≥7 points) | 28.8% | 30.5% | ARR 1.7% (favoring intensive) | NNT 59 (to prevent one worsening) |
| EQ-5D utility index (change) | −0.0365 | −0.0463 | Difference +0.010 (0.002 to 0.017) | NA |
| Domain category changes | No between-group differences across 5 domains | — | NA | |
Limitations
- HRQoL measured only at baseline and study end; transient effects not captured.
- ~4% missing final HRQoL; potential but unlikely bias.
- Ceiling effect: 63% at maximum utility at baseline.
- Open-label design; generalizability largely Chinese settings.
Funding
Chinese government grants; free drugs; Servier research support—possible sponsor bias.
Citation
Huang X, Zhang H, Li Y, et al. Modest Effects of Intensive Blood Pressure–Lowering on Quality of Life in Patients at High Cardiovascular Risk: The ESPRIT Trial. Journal of the American College of Cardiology. 2025;86(17):1392–1401. doi:10.1016/j.jacc.2025.06.010.