One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial

Victor D. Dinglas; Ramona O. Hopkins; Amy W. Wozniak; Catherine L. Hough; Peter E. Morris; James C. Jackson; Pedro A. Mendez-Tellez; O. Joseph Bienvenu; E. Wesley Ely; Elizabeth Colantuoni; Dale M. Needham

doi:10.1136/thoraxjnl-2015-208017

One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial

Victor D. Dinglas, Ramona O. Hopkins, Amy W. Wozniak, Catherine L. Hough, Peter E. Morris, James C. Jackson, Pedro A. Mendez-Tellez, O. Joseph Bienvenu, E. Wesley Ely, Elizabeth Colantuoni, Dale M. Needham

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62 Scopus citations

Abstract

Background: 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. Aim: To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS. Methods: 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. Results: 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. Conclusions: 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.

Original language	English
Pages (from-to)	401-410
Number of pages	10
Journal	Thorax
Volume	71
Issue number	5
DOIs	https://doi.org/10.1136/thoraxjnl-2015-208017
State	Published - May 2016

Bibliographical note

Funding Information:
National Heart, Lung and Blood Institute funded this follow-up study (N01HR56170, R01HL091760 and 3R01HL091760-02S1) and the Statins for Acutely Injured Lungs from Sepsis (SAILS) trial (contracts HHSN268200536165C to HHSN268200536176C and HHSN268200536179C), along with the Johns Hopkins Institute for Clinical and Translational Research (UL1 TR 000424-06). Additionally, the SAILS trial was supported by the Investigator-Sponsored Study Program of AstraZeneca. All researchers are independent of the funding bodies.

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

UN SDGs

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10.1136/thoraxjnl-2015-208017

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Dinglas, V. D., Hopkins, R. O., Wozniak, A. W., Hough, C. L., Morris, P. E., Jackson, J. C., Mendez-Tellez, P. A., Bienvenu, O. J., Ely, E. W., Colantuoni, E., & Needham, D. M. (2016). One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial. Thorax, 71(5), 401-410. https://doi.org/10.1136/thoraxjnl-2015-208017

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title = "One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial",

abstract = "Background: 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. Aim: To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS. Methods: 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. Results: 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. Conclusions: 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.",

author = "Dinglas, {Victor D.} and Hopkins, {Ramona O.} and Wozniak, {Amy W.} and Hough, {Catherine L.} and Morris, {Peter E.} and Jackson, {James C.} and Mendez-Tellez, {Pedro A.} and Bienvenu, {O. Joseph} and Ely, {E. Wesley} and Elizabeth Colantuoni and Needham, {Dale M.}",

note = "Funding Information: National Heart, Lung and Blood Institute funded this follow-up study (N01HR56170, R01HL091760 and 3R01HL091760-02S1) and the Statins for Acutely Injured Lungs from Sepsis (SAILS) trial (contracts HHSN268200536165C to HHSN268200536176C and HHSN268200536179C), along with the Johns Hopkins Institute for Clinical and Translational Research (UL1 TR 000424-06). Additionally, the SAILS trial was supported by the Investigator-Sponsored Study Program of AstraZeneca. All researchers are independent of the funding bodies.",

year = "2016",

month = may,

doi = "10.1136/thoraxjnl-2015-208017",

language = "English",

volume = "71",

pages = "401--410",

number = "5",

}

Dinglas, VD, Hopkins, RO, Wozniak, AW, Hough, CL, Morris, PE, Jackson, JC, Mendez-Tellez, PA, Bienvenu, OJ, Ely, EW, Colantuoni, E & Needham, DM 2016, 'One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial', Thorax, vol. 71, no. 5, pp. 401-410. https://doi.org/10.1136/thoraxjnl-2015-208017

TY - JOUR

T1 - One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome

T2 - Prospective follow-up of SAILS randomised trial

AU - Dinglas, Victor D.

AU - Hopkins, Ramona O.

AU - Wozniak, Amy W.

AU - Hough, Catherine L.

AU - Morris, Peter E.

AU - Jackson, James C.

AU - Mendez-Tellez, Pedro A.

AU - Bienvenu, O. Joseph

AU - Ely, E. Wesley

AU - Colantuoni, Elizabeth

AU - Needham, Dale M.

N1 - Funding Information: National Heart, Lung and Blood Institute funded this follow-up study (N01HR56170, R01HL091760 and 3R01HL091760-02S1) and the Statins for Acutely Injured Lungs from Sepsis (SAILS) trial (contracts HHSN268200536165C to HHSN268200536176C and HHSN268200536179C), along with the Johns Hopkins Institute for Clinical and Translational Research (UL1 TR 000424-06). Additionally, the SAILS trial was supported by the Investigator-Sponsored Study Program of AstraZeneca. All researchers are independent of the funding bodies.

PY - 2016/5

Y1 - 2016/5

N2 - Background: 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. Aim: To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS. Methods: 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. Results: 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. Conclusions: 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.

AB - Background: 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. Aim: To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS. Methods: 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. Results: 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. Conclusions: 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.

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U2 - 10.1136/thoraxjnl-2015-208017

DO - 10.1136/thoraxjnl-2015-208017

M3 - Article

C2 - 26936876

AN - SCOPUS:84960878017

SN - 0040-6376

VL - 71

SP - 401

EP - 410

JO - Thorax

JF - Thorax

IS - 5

ER -

One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: Prospective follow-up of SAILS randomised trial

Abstract

Bibliographical note

ASJC Scopus subject areas

UN SDGs

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