title: Sivelestat sodium and mortality in pneumonia patients requiring mechanical ventilation: propensity score analysis of a Japanese nationwide database.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Public Health, Health Management and Policy, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan. miwakishimoto@gmail.com.|Department of Anesthesiology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan. miwakishimoto@gmail.com.
authors.forename: Miwa
authors.initials: M
authors.lastname: Kishimoto
authors.affiliation: Department of Clinical Epidemiology and Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Hayato
authors.initials: H
authors.lastname: Yamana
authors.affiliation: Department of Anesthesiology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan.
authors.forename: Satoki
authors.initials: S
authors.lastname: Inoue
authors.affiliation: Department of Public Health, Health Management and Policy, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Noda
authors.affiliation: Department of Public Health, Health Management and Policy, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Myojin
authors.affiliation: Department of Clinical Epidemiology and Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Matsui
authors.affiliation: Department of Clinical Epidemiology and Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Yasunaga
authors.affiliation: Department of Anesthesiology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kawaguchi
authors.affiliation: Department of Public Health, Health Management and Policy, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-0813, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Imamura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual; D005260:Female; D005998:Glycine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy*; D057216:Propensity Score; D012121:Respiration, Artificial; D012189:Retrospective Studies; D015842:Serine Proteinase Inhibitors / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*
chemical_list: D015842:Serine Proteinase Inhibitors; D013449:Sulfonamides; C069195:sivelestat; D005998:Glycine
keywords: Acute respiratory distress syndrome; Outcomes assessment; Pneumonia; Propensity score matching; Sivelestat