PT - JOURNAL ARTICLE AU - Peter Schenk AU - Alexander O. Spiel AU - Felix Hüttinger AU - Micheline Gmeiner AU - Josefine Fugger AU - Martina Pichler AU - Gernot Pichler AU - Susanne Schmeikal AU - Wolfgang Janistyn AU - Stefan Schügerl AU - Constantin Sajdik AU - Harald Herkner TI - Can Simvastatin reduce COPD Exacerbations? A Randomised Double Blind Controlled Study AID - 10.1183/13993003.01798-2020 DP - 2021 Jan 01 TA - European Respiratory Journal PG - 2001798 4099 - http://erj.ersjournals.com/content/early/2020/12/17/13993003.01798-2020.short 4100 - http://erj.ersjournals.com/content/early/2020/12/17/13993003.01798-2020.full AB - Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalisation and need for mechanical ventilation.We performed a randomised double-blind placebo-controlled single-center trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for COPD criteria II-IV at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and main outcome parameter was time to first exacerbation.Overall 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 versus 140 days, log-rank test p<0.001. Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34–0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) versus 147 (59%), p=0.003. The annualised exacerbation rate was 1.45 per patient-year in the simvastatin group and 1.9 in the placebo group (IRR 0.77, 95% CI 0.60 to 0.99).We found no effect on quality of life, lung function, 6-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).In our single-center RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Schweitzer has nothing to disclose.Conflict of interest: Scientific research grant for performing the study by Life Science 2010, NÖ Forschungs- und Bildungsges.m.b.H., Austria, as declared in the manuscriptConflict of interest: Dr. Spiel has nothing to disclose.Conflict of interest: Dr. Hüttinger has nothing to discloseConflict of interest: Dr. Micheline Gmeiner has nothing to discloseConflict of interest: Josefine Fugger, aHPh, has nothing to discloseConflict of interest: Martina Pichler has nothing to discloseConflict of interest: Dr. Gernot Pichler has nothing to discloseConflict of interest: Dr. Susanne Schmeikal has nothing to discloseConflict of interest: Dr. Wolfgang Janistyn has nothing to discloseConflict of interest: Dr. Stefan Schügerl has nothing to discloseConflict of interest: Dr. Constantin Sajdik has nothing to discloseConflict of interest: Dr. Herkner has nothing to disclose.