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NIH-funded studies find statins provide no benefit to COPD, ARDS outcomes

Embargoed for Release:
May 18, 2014, 3:00 PM EDT

Statin therapy does not prevent exacerbations of chronic obstructive pulmonary disease (COPD) or lower mortality from acute respiratory distress syndrome (ARDS), report two studies that rigorously tested the benefit of the cholesterol-lowering drugs on outcomes in the lung diseases.

The findings from the studies funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health will be presented at the American Thoracic Society (ATS) annual meeting on May 18, with corresponding online publication in the New England Journal of Medicine.

“Treatment options for COPD and ARDS are limited,” said 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.”

“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 said.

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.

“There are many indications for taking statins,” Said Dr. Tony Punturieri, program officer in NHLBI’s Division of Lung Diseases for STATCOPE. “People should check with their doctors about their statins.  These results just show that statins do not prevent exacerbations of COPD or lower mortality from acute respiratory distress.”

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.

“This study is an excellent example of developing international collaborations to address important health research questions that are relevant to patients across the globe,” said Jean Rouleau, M.D., scientific director of the CIHR Institute of Circulatory and Respiratory Health in Montreal, Canada. 

For more information or to schedule an interview with an NHLBI spokesperson, please contact the NHLBI Office of Communications at 301-496-4236 or NHLBI_News@nhlbi.nih.gov

Supplemental Information

SAILS at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT00979121

STATCOPE at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT01061671