Clinical Utility of the Sivelestat for the Treatment of ALI/ARDS: Moving on in the Controversy?

Acute respiratory distress syndrome (ARDS) is a serious condition that can arise following direct or indirect acute lung injury (ALI). It is heterogeneous and has a high mortality rate. Supportive care is the mainstay of treatment and there is no definitive pharmacological treatment as yet. In nonclinical studies, neutrophil elastase inhibitor sivelestat appears to show benefit in ARDS without inhibiting the host immune defense in cases of infection. In clinical studies, the efficacy of sivelestat in the treatment of ARDS remains controversial. The currently available evidence suggests that sivelestat may show some benefit in the treatment of ARDS, although large, randomized controlled trials are needed in specific pathophysiological conditions to explore these potential benefits.