HARP-2 (secondary analysis)
Trial question
What is the role of simvastatin in patients with ARDS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 511
511 patients (220 female, 291 male).
Inclusion criteria: patients with acute lung injury or ARDS admitted to the ICU within the previous 48 hours.
Key exclusion criteria: assessed > 48 hours after onset of ARDS, pregnancy, receipt of statins within the previous 2 weeks, severe liver disease, severe renal impairment without receipt of RRT.
Interventions
N=247 simvastatin (at a dose of 80 mg/day for up to 28 days).
N=264 placebo (matching placebo for 28 days).
Primary outcome
Death at day 28 in group with high baseline plasma interleukin-18
24%
36.8%
36.8 %
27.6 %
18.4 %
9.2 %
0.0 %
Simvastatin
Placebo
Significant
decrease ▼
NNT = 7
Significant decrease in death at day 28 in group with high baseline plasma IL-18 (24% vs. 36.8%; RR 0.65, 95% CI 0.16 to 1.14).
Secondary outcomes
No significant difference in death at day 28 in group with low baseline plasma IL-18 (17.8% vs. 17.2%; RR 1.04, 95% CI -5.03 to 7.11).
Conclusion
In patients with acute lung injury or ARDS admitted to the ICU within the previous 48 hours, simvastatin was superior to placebo with respect to death at day 28 in group with high baseline plasma IL-18.
Reference
Andrew James Boyle, Peter Ferris, Ian Bradbury et al. Baseline plasma IL-18 may predict simvastatin treatment response in patients with ARDS: a secondary analysis of the HARP-2 randomised clinical trial. Crit Care. 2022 Jun 7;26(1):164.
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