Research performed at the University of Michigan Health System and hospitals across the United and Canada tested the benefit of the cholesterol-lowering drugs on outcomes in the lung diseases.
Jeffrey L. Curtis, M.D., a critical care specialist at the U-M and chief of pulmonary and critical care medicine at the VA Ann Arbor Healthcare system, MeiLan Han, M.D., and Fernando J. Martinez, M.D., co-authored a paper published the New England Journal of Medicine about the findings.
“Treatment options for COPD and ARDS are limited,” says James Kiley, Ph.D., director of NHLBI’s Division of Lung Diseases. “Even though retrospective analysis of some previous studies had suggested that people treated with statins for other reasons did better with their lung diseases, our well-designed prospective study directly comparing statins to a placebo did not show benefits.”
Inflammation contributes to worsening lung function and associated complications such as hospitalization, the need for ventilator support, and death in COPD and ARDS. While statins are used primarily to lower cholesterol, they may also reduce inflammation and other pathways important in lung disease.
The NHLBI initiated two separate studies to clinically address the effects of statins on lung diseases.
The STATCOPE (Simvastatin for the Prevention of COPD Exacerbations) study compared the effects of generic simvastatin against placebo in 885 adults with COPD; the SAILS (Statins for Acutely Injured Lungs from Sepsis) study compared rosuvastatin and placebo in 745 adults hospitalized with sepsis-associated ARDS. No participant in either study was taking statins before being enrolled.
Both studies were stopped early because there was very little chance of showing that statins would improve any clinical outcome for either lung disease.
COPD patients taking statins experienced no reduction in the frequency of flare-ups or other adverse events. ARDS patients on statins showed no reduction in death or days free of the mechanical ventilator.
The SAILS study also found that statins might be harmful to liver and kidney function in ARDS patients, but no increased adverse events were seen in STATCOPE.
SAILS was carried out at 44 enrolling hospitals across the United States as part of NHLBI’s ARDS Clinical Trials Network. STATCOPE involved 45 participating hospitals across the United States and Canada as part of NHLBI’s COPD Clinical Research Network and CIHR's Canadian Respiratory Research Network.
“These studies are two more examples of why it is so important to test all potential leads for new therapies in rigorously designed clinical studies in order to give caregivers what they need to make well informed decisions,” Kiley says.
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.