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May 29, 2014
Simvastatin Didn’t Reduce COPD Exacerbations, Improve
Lung Function Philadelphia—Despite retrospective studies indicating that statins can decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD), a large, multicenter, randomized trial did not bear that out. The results were reported recently at the American Thoracic Society’s annual international scientific meeting in San Diego, with simultaneous publication in the New England Journal of Medicine. “This is the first randomized, controlled trial to examine the question of whether the class of drugs called statins (simvastatin) may be useful in preventing COPD exacerbations,” said Gerard J. Criner, MD, Director of Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia. “That turns out not to be the case, This study suggests that statins' purported non-cholesterol-lowering anti-inflammatory effects do not extend to COPD.” The National Heart, Lung, and Blood Institute (NHLBI)-funded study was carried out at 45 sites in the United States and Canada. The study's 877 participants were divided into two groups: 430 who took 40 mg daily of simvastatin and 447 who took a daily placebo. Participants were followed for at least 12 months, and some as long as 36 months. Study subjects, ranging in age from 40 to 80, all had moderate-to-severe COPD and were not otherwise taking statins. All were current or former smokers who also met one of the following other criteria: they used oxygen supplementation either currently or in the past, they were prescribed systemic corticosteroids and or antibiotics in the past year, or had received emergency care or been hospitalized with a flare-up in the past year. To document the study's primary and secondary outcomes measures—the rate of exacerbation, defined as the number of exacerbation events per participant year as well as time to first exacerbation; severity of exacerbations; quality of life; and changes in lung function as measured by spirometry—study participants visited clinics every 3 months and received monthly telephone calls. Results indicate that COPD exacerbation rates were similar in the two groups: 1.36 per year among those taking simvastatin and 1.39 per year for the placebo group. The median number of days to first exacerbation also did not differ significantly: 223 days for simvastatin and 231 days for placebo. The severity of exacerbation was not affected by whether the patient took simvastatin or placebo, and lung function or general or disease-specific quality of life was not improved in the group receiving the statin. Rates of adverse events, such as pneumonia and deaths were similar for the two groups, although, as expected at the 1-year follow up, patients taking simvastatin had lower cholesterol and triglyceride levels than those receiving a placebo. The study was stopped early because an interim analysis conducted by the data safety monitoring board found little or no benefit for using simvastatin to control COPD exacerbations. “In conclusion, 40 mg of daily simvastatin added to usual care did not reduce exacerbation rate or prolong time to exacerbation in moderate to severe COPD patients at risk for exacerbation,” the researchers report. “Furthermore simvastatin had no effect on lung function, quality of life, severe adverse effects or mortality.” Criner said that COPD patients taking statins for other reasons should continue on the drugs. “COPD patients benefit from the use of statins just like any other group of patients that benefit from statins according to established indications to reduce cardiovascular risk,” he explained. “What this study shows is that patients who do not meet already established criteria for statin therapy should not take statins only to prevent COPD exacerbations.”
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