title: One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial.
abstract: Prior randomised trials have evaluated statins in patients with sepsis and acute respiratory distress syndrome (ARDS), but there has been no comprehensive evaluation of long-term effects, despite potential neuromuscular and mental health adverse effects of these drugs.
  
  
  
  To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS.
  
  
  
  Prospective follow-up evaluation of the ARDS Clinical Trials Network Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo in 568 mechanically ventilated patients with sepsis-associated ARDS, with blinded 6-month outcome assessment performed in the 272 eligible survivors for age-adjusted and sex-adjusted 36-Item Short Form Health Survey (SF-36) physical function and mental health domains, and in 84 eligible survivors for the 6 min walk test, along with secondary outcomes evaluations of survival, and additional patient-reported and performance-based measures at 6-month and 12-month follow-up.
  
  
  
  Over 1-year follow-up, there was no significant difference in cumulative survival in the rosuvastatin versus placebo groups (58% vs 61%; p=0.377), with survivors demonstrating substantial impairments in physical function and mental health. Rosuvastatin versus placebo had no effect (mean treatment effect (95% CI)) on SF-36 physical function (0 (-7 to 8), p=0.939) or mental health (-6 (-12 to 1) p=0.085) domains, 6 min walk distance (per cent predicted: 2 (-9 to 14), p=0.679) or the vast majority of secondary outcomes.
  
  
  
  Over 1-year follow-up, patients with sepsis-associated ARDS had high cumulative mortality, with survivors commonly experiencing impairments in physical functioning and performance, and mental health. Randomisation to rosuvastatin had no effect on these outcomes.
  
  
  
  NCT00979121 and NCT00719446.
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Victor D
authors.initials: VD
authors.lastname: Dinglas
authors.affiliation: Pulmonary and Critical Care Division, Department of Medicine, Intermountain Medical Center, Murray, Utah, USA Psychology Department and Neuroscience Center, Brigham Young University, Provo, Utah, USA Center for Humanizing Critical Care, Intermountain Health Care, Murray, Utah, USA.
authors.forename: Ramona O
authors.initials: RO
authors.lastname: Hopkins
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Amy W
authors.initials: AW
authors.lastname: Wozniak
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, Washington, USA.
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Hough
authors.affiliation: Division of Pulmonary, Critical Care & Sleep Medicine, University of Kentucky, Lexington, Kentucky, USA.
authors.forename: Peter E
authors.initials: PE
authors.lastname: Morris
authors.affiliation: Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
authors.forename: James C
authors.initials: JC
authors.lastname: Jackson
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Mendez-Tellez
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: O Joseph
authors.initials: OJ
authors.lastname: Bienvenu
authors.affiliation: Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA Geriatric Research, Education and Clinical Center Service, Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, Tennessee, USA.
authors.forename: E Wesley
authors.initials: EW
authors.lastname: Ely
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Colantuoni
authors.affiliation: Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Dale M
authors.initials: DM
authors.lastname: Needham
mesh_terms: D015992:Body Mass Index; D048909:Diabetes Complications / Q000150:complications; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012128:Respiratory Distress Syndrome / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality; D012307:Risk Factors; D000068718:Rosuvastatin Calcium / Q000627:therapeutic use*; D018805:Sepsis / Q000150:complications*; D016037:Single-Blind Method; D016896:Treatment Outcome; D014481:United States; D016138:Walking
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000068718:Rosuvastatin Calcium
keywords: ARDS