Statin drugs, commonly used to decrease cholesterol levels, doesn’t reduce the number and severity of outbreaks in chronic obstructive pulmonary disease (COPD). That was the result of a clinical trial from the Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia.
The study, presented at the American Thoracic Society’s annual international scientific meeting in San Diego and published online in the The New England Journal of Medicine, analyzed the hypothesis that statin drugs were beneficial to COPD patients. The theory was that the anti-inflammatory effect of the drugs would decrease the symptoms of the inflammatory disease of the airways and lungs COPD.
“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 Dr. Criner, Director of Temple’s Lung Center and Professor of Medicine at Temple University School of Medicine.
Similar studies were performed in the past, but suggested a potentially significant benefit in improving lung function and decreasing morbidity and mortality. “That turns out not to be the case,” Dr. Criner said. “This study suggests that statins’ purported non-cholesterol-lowering anti-inflammatory effects do not extend to COPD.”
The study was conducted at 45 investigational sites in the US and Canada, and included 877 patients with moderate to severe COPD, between 40 and 80 years old. 430 of them were administrated with 40 mg. daily of simvastatin, a common statin drug used to prevent heart attack and stroke, and 447 with placebo, and all were followed between 12 to 36 months.
The disease is characterized by acute exacerbations that provoke episodes of coughing with mucus, shortness of breath, wheezing and a feeling of tightness in the chest. The results showed that the number of exacerbation events were similar in the two groups (1.36 per year in the group that took simvastatin and 1.39 per year in the placebo group).
The number of days to first exacerbation was also similar (223 days, compared to 231). The severity suffered no effects, nor did the lung function or general or disease-specific quality of life. The number of adverse events and deaths were alike. “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 reported. “Furthermore simvastatin had no effect on lung function, quality of life, severe adverse effects or mortality.”
Dr. Criner alerted that this finding does not mean COPD patients should stop taking statins prescribed for cholesterol or other cardiovascular disease, it just means it doesn’t make any difference to COPD symptoms. “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,” Dr. Criner said. “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.”
The clinical trial not only dissolved this myth, but it also increased knowledge about the inflammatory nature of COPD. “What this does is allow us to pursue other avenues of anti-inflammatory treatment so we can develop new therapies that are so desperately needed,” Dr. Criner said.
The study was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
“More work is currently being done and planned to be done that will target more viable pathways and mechanisms to prevent or alleviate the consequences of COPD exacerbations,” he added.
About 75 percent of the annual expenditure on COPD care is targeted to treat acute exacerbations, which represents $49.9 billion. Around 12 million Americans are diagnosed with COPD and is the third leading cause of death in the United States. Other 12 million have reduced lung function, which is known as an underdiagnosis of COPD.