Heart failure & cardiomyopathies
Sacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF
Pooled resultResult — go to the resultRelative risk 0.78 95% CI 0.61–0.99Authors' conclusion
In pooled analyses of PARAGLIDE-HF and PARAGON-HF, sacubitril/valsartan reduced cardiovascular and renal events among patients with HF with mildly reduced or preserved ejection fraction.
Study context
- Population
- Heart failure (HF) with mildly reduced or preserved EF (LVEF >40% in PARAGLIDE-HF, ≥45% in PARAGON-HF) with worsening HF event within 30 daysall participants pooled n = 5262
- Participants
- 1,088 participants
- Comparison
- Sacubitril/valsartan vs valsartan
- Outcome
- Composite of:
- Total worsening HF events (first and recurrent HF hospitalisations and urgent visits)
- CV death
Methodological detailsmulticentre, double-blind, active-controlled
- Multicentre
- Double-blind
- Active-controlled
Pooled result
As reported in the abstract
Relative risk
0.78
95% CI 0.61–0.99
P = 0.042
Sacubitril/valsartanvs Valsartan
RR 0.78 (95% CI 0.61–0.99); P = 0.042
Further pooled results
| Outcome | Estimate | P value | |
|---|---|---|---|
| Total worsening HF events and CV death, all participants pooledn = 5262 | RR 0.86 (95% CI 0.75–0.98) | P = 0.027 | |
| Total worsening HF events and CV death by LVEF, all participants pooled (subgroup)Sacubitril/valsartanvs ValsartanLVEF ≤60% | RR 0.78 (95% CI 0.66–0.91) | ||
| Total worsening HF events and CV death by LVEF, all participants pooled (subgroup)Sacubitril/valsartanvs ValsartanLVEF >60% | RR 1.09 (95% CI 0.86–1.40) | ||
| Renal composite (≥50% eGFR decline, end-stage renal disease or renal death), primary pooled analysis | HR 0.67 (95% CI 0.43–1.05) | P = 0.080 | |
| Renal composite, all participants pooled | HR 0.60 (95% CI 0.44–0.83) | P = 0.002 | |
| 0.512Ratio (log scale) |
- Total worsening HF events and CV death by LVEF, all participants pooled (subgroup): Pinteraction = 0.021
Total worsening HF events and CV death, all participants pooled
- First nominal statistical significance reached by Day 9 after randomisation
Original publication
Sacubitril/valsartan in heart failure with mildly reduced or preserved ejection fraction: a pre-specified participant-level pooled analysis of PARAGLIDE-HF and PARAGON-HF. Eur Heart J. Published 21 May 2023. doi:10.
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