May 29, 2014

Studies shows statins no help for COPD or ARDS
Researchers participated in a multi-site study that disproved a once-promising theory that statins might have a beneficial effect on lung function.

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copdTwo studies in the May 22, 2014, issue of the New England Journal of Medicine indicate that statins — commonly prescribed cholesterol-lowering medications — do not improve the health of patients who have chronic obstructive pulmonary disease or acute respiratory distress syndrome. Investigators at the University of Alabama at Birminghamparticipated in the study of COPD patients.

The studies, funded by the National Heart, Lung and Blood Institute, one of the National Institutes of Health, were designed to prove or disprove retrospective observational studies that had indicated that statins might reduce exacerbations of COPD and improve survival in ARDS.

“Treatment options for both COPD and ARDS are limited,” said James Kiley, Ph.D., director of NHLBI’s Division of Lung Diseases. “Even though retrospective observational studies had suggested that people treated with statins for other reasons did better with their lung diseases, our well-designed prospective studies 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, according to Mark Dransfield, M.D., associate professor in the Division of Pulmonary, Allergy and Critical Care Medicine and medical director of the UAB Lung Health Center.

“Exacerbations of COPD are largely tied to inflammation, and there was reason to believe that statin therapy might reduce inflammation and provide a better outcome for patients with the disease,” said Dransfield, a co-author of the COPD study. “It’s disappointing that the study ultimately did not show a benefit, as there were hopes that statins would prove to be valuable treatment option.”

The NHLBI initiated two separate clinical studies to address the effects of statins on lung diseases. The STATCOPE, or Simvastatin for the Prevention of COPD Exacerbation 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. None of the participants in either study were taking statins prior to being enrolled.

“Exacerbations of COPD are largely tied to inflammation, and there was reason to believe that statin therapy might reduce inflammation and provide a better outcome for patients with the disease. It’s disappointing that the study ultimately did not show a benefit, as there were hopes that statins would prove to be valuable treatment option.”
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, while ARDS patients on statins showed no reduction in death or days free of the mechanical ventilator.

“The results of these studies do not indicate that patients should stop taking statins that are prescribed for control of heart disease or other illness,” said Dransfield. “These results just show that statins are not specifically indicated to improve outcomes in COPD or ARDS.”

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.

The findings from these studies will be presented at the American Thoracic Society annual meeting May 18, with corresponding online publication in the “New England Journal of Medicine.”
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