Statins don’t help, may harm in COPD, sepsis-associated ARDS

Dr. Jeffrey M. Drazen and Annetine C. Gelijns, Ph.D., comment:

Finding out that statins did not help in these two trials may be

disappointing, but not knowing that – if the studies had not been done –

would have been worse, Dr. Drazen and Dr. Gelijns wrote in an

accompanying editorial in the New England Journal of Medicine.

"The cynic would say that the public’s money had been wasted – we had struck out swinging," they wrote (N. Engl. J. Med. 2014 May 18 [doi: 10.1056/NEJMe1405032]).

Treatment

with statins seemed reasonable and, on the face of it, valid for both

moderate to severe chronic obstructive pulmonary disease (COPD) and

sepsis-associated acute respiratory distress syndrome (ARDS), conditions

in which inflammatory events are thought to drive disease pathobiology.

The known pleomorphic anti-inflammatory properties of statins made them

candidates, and previous observational data suggested that they helped

patients with these conditions. Because of meager therapeutic options

for these diseases, the studies of statins had to be done, Dr. Drazen

and Dr. Gelijns argued.

"It would have been a big mistake" to

accept the observational findings without a test, they wrote. "Had we

accepted the observational data at face value, we might have spent the

cost of the trials many times over in useless treatments before

recognizing our errors."

Dr. Jeffrey M. Drazen is editor in

chief of the Journal. He reported having no disclosures. Dr. Gelijns is a

professor and chair of Health Evidence and Policy at Mount Sinai School

of Medicine, New York. She reported a financial association with MERS

International, which developed a medical event reporting system.