Simvastatin for patients with acute respiratory distress syndrome: long-term outcomes and cost-effectiveness from a randomised controlled trial

Critical Care. 2017;21(1):1-10 DOI 10.1186/s13054-017-1695-0

 

Journal Homepage

Journal Title: Critical Care

ISSN: 1364-8535 (Print); 1466-609X (Online)

Publisher: BMC

LCC Subject Category: Medicine: Internal medicine: Medical emergencies. Critical care. Intensive care. First aid

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS

A. Agus (Northern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals)
C. Hulme (Academic Unit of Health Economics, University of Leeds)
R. M. Verghis (Northern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals)
C. McDowell (Northern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals)
C. Jackson (Northern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals)
C. M. O’Kane (Centre for Infection and Immunity, Queen’s University of Belfast)
J. G. Laffey (Department of Anaesthesia, School of Medicine, HRB Galway Clinical Research Facility, Clinical Sciences Institute, National University of Ireland)
D. F. McAuley (Northern Ireland Clinical Trials Unit, Elliot Dynes Building, The Royal Hospitals)

EDITORIAL INFORMATION

Blind peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 14 weeks

 

Abstract | Full Text

Abstract Background Simvastatin therapy for patients with acute respiratory distress syndrome (ARDS) has been shown to be safe and associated with minimal adverse effects, but it does not improve clinical outcomes. The aim of this research was to report on mortality and cost-effectiveness of simvastatin in patients with ARDS at 12 months. Methods This was a cost-utility analysis alongside a multicentre, double-blind, randomised controlled trial carried out in the UK and Ireland. Five hundred and forty intubated and mechanically ventilated patients with ARDS were randomly assigned (1:1) to receive once-daily simvastatin (at a dose of 80 mg) or identical placebo tablets enterally for up to 28 days. Results Mortality was lower in the simvastatin group (31.8%, 95% confidence interval (CI) 26.1–37.5) compared to the placebo group (37.3%, 95% CI 31.6–43.0) at 12 months, although this was not significant. Simvastatin was associated with statistically significant quality-adjusted life year (QALY) gain (incremental QALYs 0.064, 95% CI 0.002–0.127) compared to placebo. Simvastatin was also less costly (incremental total costs –£3601, 95% CI –8061 to 859). At a willingness-to-pay threshold of £20,000 per QALY, the probability of simvastatin being cost-effective was 99%. Sensitivity analyses indicated that the results were robust to changes in methodological assumptions with the probability of cost-effectiveness never dropping below 90%. Conclusion Simvastatin was found to be cost-effective for the treatment of ARDS, being associated with both a significant QALY gain and a cost saving. There was no significant reduction in mortality at 12 months, Trial registration ISRCTN, 88244364. Registered 26 November 2010.