Simvastatin does not prevent exacerbations in people with moderate-to-severe chronic obstructive pulmonary disease (COPD), suggest results of a large prospective randomised placebo-controlled trial reported in The New England Journal of Medicine.
Treatment with the statin also failed to impact lung function, quality of life, severe adverse events or mortality, leading the researchers to conclude that their data “did not show a therapeutic benefit of statins in patients with moderate-to-severe COPD”.
Several previous studies have reported benefits of statin therapy in patients with COPD but all but one have been retrospective. The STATCOPE trial was undertaken to test this hypothesis in a prospective, controlled manner. It included 885 patients aged 40–80 years with COPD and a smoking history of at least 10 pack-years (calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked) who were considered to be at high risk for exacerbations.
Study participants were randomly assigned to receive simvastatin 40mg or placebo once daily and treated for a mean of 639 and 641 days, respectively. During this time there were 1,982 acute COPD exacerbations. Rates were similar in the simvastatin and placebo groups, at 1.36 and 1.39 exacerbations per person–year, respectively (P=0.54).
The median time to first exacerbation was similar between treatment groups, as was the number of non-fatal serious adverse events and deaths. Simvastatin had no effect on lung function, assessed using spirometry, or on general or respiratory-specific quality of life. As expected, levels of low-density lipoprotein cholesterol showed a greater decline over the study period in the simvastatin group than the placebo group.
The STATCOPE investigators conclude that daily use of 40mg simvastatin, in addition to usual care, “has no role in preventing exacerbations in moderate-to-severe COPD”. “The underuse of statins in persons with cardiac risk factors who have been included in retrospective studies may account in part for the differences between our findings and those previously reported,” they suggest.