6/28/23, 11:01 PM HARP-2 (secondary analysis) Pathway Feedback Search Clinical Topics Home Studies HARP 2 (secondary analysis) HARP 2 (secondary analysis) Disease Acute respiratory distress syndr 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 N = 511 57.0% male 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 36.8 % 36.8 https://web.pathway.md/studies/recA4NuARFylY4Rba 1/2 6/28/23, 11:01 PM HARP-2 (secondary analysis) Pathway 27.6 % 24 18.4 % Significant decrease 9.2 % NNT = 8 0.0 % Simvastatin Placebo 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. Open reference URL https://web.pathway.md/studies/recA4NuARFylY4Rba 2/2