While researchers are calling for studies to evaluate the effectiveness of the cholesterol lowering drugs known as statins for reducing influenza-associated deaths, one such study is just getting underway, largely on volunteerism and shoestring funding.
Newspapers reported yesterday (e.g. here, here and here) from the 2009 Infectious Diseases Society of America meeting in Philadelphia that statin use appears to be associated with a lower death rate from influenza. Using data from the 2007-2008 flu season, researchers reviewed charts from 2,800 lab-confirmed influenza-associated hospitalizations. More than 800 of these individuals were taking statins at the time. Meredith VanderMeer of the Oregon Public Health Division and her colleagues found that 2.1% of patients taking statins died within a month of being hospitalized for the flu, while 3.2% who were not taking statins died.
Statins have been suggested before as a potential alternative to antiviral drugs like oseltamivir (Tamiflu) and zanamivir (Relenza), which are more expensive and have the potential to run out in a severe pandemic. Statins may reduce the effects of the virus by dampening the immune response.
Several observational studies like the one reported today have suggested a protective effect. At a press teleconference, VanderMeer suggested that double-blind, placebo-controlled studies be carried out in a hospital setting. I haven’t seen anyone report that one such study has already begun. Gordon Bernard at Vanderbilt University is studying the effects of rosuvastatin (Crestor) in patients hospitalized with the flu. It’s a randomized, double-blind, placebo-controlled study and the researchers recruited their first patient this week, Bernard told Nature.
Finding the funding for such a study has been difficult. But, Bernard realized that the current H1N1 pandemic presents an unprecedented opportunity to study this intervention. “We’ve never seen this kind of thing happen with so many patients with severe symptom,.” he says.
In August, he and his collaborators decided to begin working on a volunteer basis to get the study underway, including getting all the necessary approvals. Astra Zeneca, which manufactures Crestor, agreed to provide medication and placebo, but would not fund that the study. “We’re still working as a volunteer group and continuing to put feelers out in every way we can,” Bernard says.
As for the positive press for statins, Bernard calls it something of a double-edged sword. “It lends credence to the idea that we should have a randomized trial,” he says, but “It also makes it difficult at the bedside.” As patients hear more about statins possibly being effective, it can complicate recruitment into placebo-controlled studies, he says.
Declan Butler contributed to the reporting of this story.