Two studies: Statin drugs don't help breathing problems
Two federally funded clinical studies have dashed hopes that cholesterol-fighting statin drugs could relieve severe or life-threatening breathing problems.
Two federally funded clinical studies have dashed hopes that cholesterol-fighting statin drugs could relieve severe or life-threatening breathing problems.
Past studies suggested patients with lung damage who were taking statins had better outcomes than patients who were not, presumably because statins can reduce inflammation and block cholesterol production.
But one of the trials, designed and led by Temple University researcher Gerard J. Criner, found that simvastatin (brand name Zocor) was no better than a placebo at reducing flare-ups of chronic obstructive pulmonary disease (COPD) in 885 current or former smokers.
An estimated 12 million Americans have been diagnosed with COPD. The theory was that a daily low dose of simvastatin would reduce periodic bouts of coughing, wheezing, breathlessness, and chest tightness. These episodes, which last three days or more, are usually treated with antibiotics, corticosteroids, or in severe cases, hospitalization and mechanical ventilation.
After two years, the average number of flare-ups was the same - 1.3 per year - for COPD patients taking statin or placebo, although the statin-takers' cholesterol levels dropped.
Criner, Temple's director of pulmonary and critical-care medicine, said symptoms of heart disease such as breathlessness and chest tightness could mimic COPD flare-ups. Previous studies may have misinterpreted cardiac benefits of statins as breathing benefits.
The new study avoided that pitfall by excluding patients who were already taking statins or who met guidelines for statin therapy.
"Statins are important for treating heart disease in COPD patients, just like in any other group of patients," he said. "But our study shows statin therapy really doesn't have a role in preventing COPD exacerbations."
The other study, conducted at 13 major medical centers, gave rosuvastatin (Crestor) or a placebo to 745 patients hospitalized with acute respiratory distress syndrome caused by a known or suspected blood infection.
Despite progress in treating the syndrome, it causes inflammation that often leads to failure of the lungs and other organs.
There was no significant difference in 60-day death rates, or in days off the ventilator, between the two study groups.
The results of both studies were presented last week at the annual meeting of the American Thoracic Society and published online in the New England Journal of Medicine.
An editorial by the journal's editor-in-chief said the studies were important to bridge the gap between circumstantial evidence of benefit and proven - or disproven - benefit.
"The cynic would say that the public's money had been wasted," wrote the journal's Jeffrey Drazen. "Although both trials had negative results, they had to be done. It would have been a big mistake to accept the [circumstantial] findings without a test."
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