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Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine
Date:9/5/2007

BRIDGEWATER, N.J., Sept. 5 /PRNewswire/ -- Results from an investigational study researching the use of PROCRIT(R) (Epoetin alfa) in medical, surgical and trauma patients admitted to an intensive care unit (ICU) were published in today's New England Journal of Medicine. The study was sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The primary objective of the study was to determine whether administration of PROCRIT would decrease the number of critically ill patients who received a red blood cell (RBC) transfusion after admission to the ICU. There was no significant difference in the percentage of patients who received a RBC transfusion between the PROCRIT and placebo groups. However, the hemoglobin increase was greater in the PROCRIT group. Despite the lack of transfusion reduction, the study showed that treatment with PROCRIT significantly reduced mortality, particularly in trauma patients admitted to the ICU.

"The improvement in mortality findings are encouraging and this is a potentially important finding in this clinical setting," said Howard Corwin, M.D., Dartmouth-Hitchcock Medical Center, Hanover, NH.

Study Design

This study was a prospective, randomized, double-blind, placebo- controlled, multi-center trial of patients aged 18 years or older who were admitted to an ICU for two days or more with a hemoglobin (Hb) less than 12 grams per deciliter of blood (g/dL). A total of 1,460 patients received either PROCRIT (n=733) or placebo (n=727) via subcutaneous injection on the first day of the study. For patients who remained in the hospital, treatment was specified for a total of three weekly doses (days 1, 8 and 15).

The primary endpoint was the percent of patients receiving any RBC transfusion through day 29. Secondary endpoints were RBC units transfused through day 42, change in Hb from baseline to day 29 and mortality at days 29 and 140. Analyses by the prospectively identified admission groups
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SOURCE Ortho Biotech Products, L.P.
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