Just over a week ago I posted an update on Xigris, concluding that the results of PROWESS-SHOCK would give us answers to help resolve some of the controversy surrounding the drug. Little did I know that the results would be announced so soon. For those who haven't heard, there was no significant difference attributable to Xigris, neither benefit nor harm, so Lilly has pulled it from the market.
According to this Medscape piece and other reports I've read the mortality in PROWESS-SHOCK was similar to that of the Xigris treatment arms of PROWESS and other Xigris trials. That means it was lower than the placebo arm of PROWESS. Impressive considering that PROWESS-SHOCK was supposed to represent the sickest of patients with sepsis. It may be that in the decade since PROWESS we've gotten better in other areas of sepsis treatment. Early goal directed therapy is gradually catching on, we've refined our approach to the use of steroids and glycemic control and perhaps we are more intelligent in the use of antibiotics. Awareness of the early diagnosis of sepsis has increased. It's ironic that Lilly's support of the Surviving Sepsis Campaign, which improved all these areas of treatment, may have diminished the role of Xigris.
No doubt the media and the pharmascolds will spin the results to read “Xigris doesn't work.” Simplistic. Xigris was a lifesaving drug in the right patient at the right time. Unfortunately that patient was just too hard to define. So, I think Lilly made the right decision to pull the drug.