I had not read this report when I blogged the topic yesterday. But it appears some of the folks at ACCP agreed with me that the robust improvements in various processes of sepsis care resulting from Lilly's promotional campaign may have helped do its sepsis drug in:
Dr. Simpson and other physicians who spoke to Reuters Health said that this time around, Xigris was more hard-pressed to beat the placebo than when it first gained approval in the U.S. and Europe.
"The treatment of severe sepsis and septic shock has undergone revolutionary changes in the past 10 years that have improved the mortality of septic shock to such a degree that it would take large, large numbers of patients to demonstrate the benefit of the drug," Dr. Simpson told Reuters Health...
In the new trial, with 1,696 patients, 28-day all-cause mortality rates were 26.4% with Xigris and 24.2% with placebo (p=0.31).
By contrast, the original PROWESS study showed 28-day mortality rates of 24.7% with Xigris and 30.8% with placebo (p=0.005).
Most experts agree that improvements in caregiver training and mechanical ventilation have reduced sepsis mortality.
Dr. Jeffrey Vender, an anesthesiologist at the University of Chicago, told Reuters Health he attributes the reduction in mortality to low-volume, low-pressure ventilation that entered widespread use in the early 2000s.
He and Dr. Simpson both said early goal-directed therapy, including earlier identification and management of patients at risk, has had an important role in improved sepsis survival.
That educational shift, Dr. Vender said, is a "by-product" of the introduction of Xigris.
"Sepsis education and Xigris were linked. Lilly spent fortunes trying to educate the caregiver market in relationship to the management of sepsis, of which Xigris was just one element," Dr. Vender said.
So a really important lesson from this trial, which has received little attention, is that in the past decade we have made a dent in the mortality form sepsis attributable to multiple care process improvements.