Sivelestat sodium and mortality in pneumonia patients requiring mechanical ventilation: propensity score analysis of a Japanese nationwide database.

ABSTRACT

PURPOSE: Sivelestat is widely used in Japan for the treatment of acute respiratory distress syndrome caused by pneumonia. Although the efficacy of sivelestat was reported in several Japanese studies in the early 2000 s, a multinational randomized control trial did not support these findings. We therefore conducted the present study to examine the association between the use of sivelestat and mortality in pneumonia patients requiring mechanical ventilation. METHODS: We conducted a retrospective observational study using the Diagnosis Procedure Combination database, a national inpatient database in Japan. We identified pneumonia patients requiring mechanical ventilation who were hospitalized between April 2012 and March 2014. Propensity score matching was performed to compare 7- and 30-day mortality between patients with and without sivelestat use. RESULTS: The eligible patients (n = 16,471) were categorized into the sivelestat (n = 1707) and control (n = 14,764) groups. The unmatched comparison showed significant differences between the sivelestat and control groups in both 7-day mortality (11.0 vs. 7.6%, p < 0.001) and 30-day mortality (29.9 vs. 19.7%, p < 0.001). In the 1516 pairs of propensity-matched patients, there were no significant differences in 7-day mortality (sivelestat vs. CONTROL 10.2 vs. 10.9%, p = 0.516) and 30-day mortality (sivelestat vs. control 29.0 vs. 29.0%, p = 1.000). CONCLUSIONS: The propensity-matched analyses revealed that the use of sivelestat was not associated with decreased mortality for pneumonia patients requiring mechanical ventilation.