Abstract
Background Several studies have shown that statins have beneficial effects in COPD regarding lung function decline, rates and severity of exacerbation, hospitalisation and need for mechanical ventilation.
Methods We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2–4 at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and the main outcome parameter was time to first exacerbation.
Results 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 events per patient-year in the simvastatin group and 1.9 events per patient-year in the placebo group (incidence rate ratio 0.77, 95% CI 0.60–0.99). We found no effect on quality of life, lung function, 6-min walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).
Conclusion In our single-centre RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.
Abstract
Acute exacerbations of COPD cause a lot of suffering and healthcare burden. In this study, p.o. simvastatin 40 mg·day−1 reduced time to first exacerbation and exacerbation frequency in a double-blind, randomised controlled trial. https://bit.ly/3nHINet
Footnotes
This article has an editorial commentary: https://doi.org/10.1183/13993003.00342-2021
This article has supplementary material available from erj.ersjournals.com
This clinical trial is registered with EUDRACT number 2011-004166-16. Individual patient data are available. The study protocol and the informed consent form are available.
Conflict of interest: P. Schenk reports a scientific research grant for performing the study by Life Science 2010, NÖ Forschungs- und Bildungsges m.b.H., Austria.
Conflict of interest: A.O. Spiel has nothing to disclose.
Conflict of interest: F. Hüttinger has nothing to disclose.
Conflict of interest: M. Gmeiner has nothing to disclose.
Conflict of interest: J. Fugger has nothing to disclose.
Conflict of interest: M. Pichler has nothing to disclose.
Conflict of interest: G. Pichler has nothing to disclose.
Conflict of interest: S. Schmeikal has nothing to disclose.
Conflict of interest: W. Janistyn has nothing to disclose.
Conflict of interest: S. Schügerl has nothing to disclose.
Conflict of interest: C. Sajdik has nothing to disclose.
Conflict of interest: H. Herkner has nothing to disclose.
Support statement: Supported by Life Science 2010, NÖ Forschungs- und Bildungsges m.b.H. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received May 14, 2020.
- Accepted December 16, 2020.
- Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org