Statin therapy for acute respiratory distress syndrome: an individual patient data meta-analysis of randomised clinical trials

Purpose We performed an individual patient data meta-analysis to assess the possible benefits and harms of statin therapy in adults with acute respiratory distress syndrome (ARDS) and to investigate effects in specific ARDS subgroups. Methods We identified randomised clinical trials up to 31 October 2016 that had investigated statin therapy versus placebo in patients with ARDS. Individual patient data from each trial were compiled. Conventional two-stage meta-analyses were performed for primary and secondary outcomes, and one-stage regression models with single treatment–covariate interactions for subgroup analyses. Risk of bias was assessed using the Cochrane Risk of Bias Tool. Results Six trials with a total of 1755 patients were included. For the primary outcomes, there was no significant effect of statin therapy on 28-day mortality [relative risk (RR) 1.03, 95% CI 0.86–1.23], ventilator-free days (mean difference 0.34 days, 95% CI −0.68 to 1.36) or serious adverse events (RR 1.14, 95% CI 0.84–1.53). There was a significantly increased incidence of raised serum creatine kinase or transaminase levels with statin therapy (106/879; 12.1%) versus control (78/876; 8.9%) (RR 1.40, 95% CI 1.07–1.83, p = 0.015). There were no significant treatment–covariate interactions in the predefined subgroups investigated. Conclusions We found no clinical benefit from initiation of statin therapy in adult patients with ARDS, either overall or in predefined subgroups. While there was an increased incidence of raised serum creatine kinase and transaminase levels, there was no difference in serious adverse events among groups. Therefore, we do not recommend initiation of statin therapy for the treatment of ARDS.