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Lilly and Investor Group Form New Critical Care Company BioCritica, Sign Xigris License Agreement
Date:5/23/2011

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  • Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location

    • Should clinically important bleeding occur, immediately stop the infusion of Xigris. Continued use of other agents affecting the coagulation system should be carefully assessed. Once adequate hemostasis has been achieved, continued use of Xigris may be reconsidered.

    • Mortality In Patients with Single Organ Dysfunction and Recent Surgery  

    Among the small number of patients in PROWESS, with single organ dysfunction and recent surgery (surgery within 30 days prior to study treatment), all-cause mortality was numerically higher in the Xigris group (28day: 10/49; inhospital: 14/48) compared with the placebo group (28day: 8/49; inhospital: 8/47).

    In an analysis of the subset of patients with single organ dysfunction and recent surgery from the ADDRESS study, which enrolled septic patients not at high risk of death, allcause mortality was also higher in the Xigris group (28day: 67/323; inhospital: 76/325) compared with the placebo group (28day: 44/313; inhospital: 62/314). Single organ dysfunction patients with recent surgery may not be at high risk of death irrespective of APACHE II score. Therefore, these patients may not be among the indicated population.

    • Patients on Prophylactic Heparin when Xigris is Initiated

    Clinicians should consider continuing heparin for venous thromboembolism (VTE) prophylaxis when initiating Xigris, unless discontinuation is medically necessary. In a randomized study of prophylactic heparin versus placebo in 1935 adult severe sepsis patients treated with Xigris, mortality and the rate of serious adverse events were increased in the subgroup of 434 patients whose heparin was stopped on study entry by randomizat
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    SOURCE Eli Lilly and Company
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