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Can Simvastatin reduce COPD exacerbations? A randomized double blind controlled study

Peter Schenk, Spiel A, Hüttinger F, Gmeiner M, Fugger J, Pichler M, Pichler G, Schmeikal S, Janistyn W, Schügerl S, Sajdik C and Herkner H

Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalization and need for mechanical ventilation. We performed a randomized double-blind placebocontrolled 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 vs. 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%) vs. 147 (59%), p = 0.003. The annualized 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, six-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 vs. 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.