Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.
By Akanksha, Pharmacology Correspondent, [RxPG] Eli Lilly and FDA notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis. A planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of "Composite Time to Complete Organ Failure Resolution" over 14 days.
A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted.
Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.
In its letter to the Health professionals Eli Lilly and Company (Lilly) said that it recently stopped enrollment in study EVBP, a randomized, double-blind, placebo-controlled trial of Xigris® [drotrecogin alfa (activated)] in pediatric patients with severe sepsis.
Xigris is not indicated for use in pediatric severe sepsis.
The DMC also noted a numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group. Over the infusion period (study days 0-6) the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less. Mortality, the rate of serious adverse events, overall serious bleeding events, and major amputations appeared to be similar in the Xigris and placebo groups.
Data collection in study EVBP is ongoing. All patients enrolled will be followed for the complete 28-day study period. Full results of the data will be available in the latter part of 2005 and publicly presented as soon as possible.
Lilly is committed to ensuring that Xigris is used as safely and effectively as possible and to providing you with the most current product information. You can assist us with monitoring the safety of Xigris by reporting adverse events to the Lilly Answer Center at 1-800-LILLYRx (1-800-545-5979).
Alternatively, adverse events may be reported to the FDAs MedWatch reporting system
(phone: 1-800-FDA-1088, facsimile: 1-800-FDA-0178, or website: www.fda.gov/medwatch).
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