Efficacy of early sivelestat administration on acute lung injury and acute respiratory distress syndrome

ABSTRACT Background and objective The efficacy of sivelestat, a neutrophil elastase inhibitor, for acute lung injury ( ALI ) and acute respiratory distress syndrome ( ARDS ) remains controversial. We investigated the role of sivelestat in ALI / ARDS patients on mortality as an end point between the sivelestat group and the non‐sivelestat group within 7 days of admission. Methods This study was performed using the Japanese nationwide administrative database (Diagnostic Procedure Combination; DPC ) in 2012. We employed the propensity score weighting method with a Cox proportional hazards model to compare the mortality between the sivelestat group and the non‐sivelestat group. Results A total of 4276 patients were eligible for this study; 1997 patients were treated with sivelestat and 2279 patients did not receive sivelestat within 7 days of admission. After adjusting for confounds, the mortality within 3 months was significantly lower in the sivelestat group compared with the non‐sivelestat group (weighted hazard ratio: 0.83; 95% CI : 0.75–0.93; P < 0.002). Multiple regression analysis revealed that younger age, absence of cancer, no need for haemodialysis and no use of high‐dose methylprednisolone were significantly correlated with treatment success (survive). Conclusion These results of this retrospective and observational study suggest that administration of sivelestat within 7 days of admission may improve the prognosis of patients with ALI / ARDS . To our knowledge, this is the largest study to evaluate the efficacy of sivelestat on ALI / ARDS .