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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

(trauma, surgery non-trauma and medical non-trauma) were performed similarly to the overall population.

Study Findings

There was no significant difference in the percentage of patients who received a RBC transfusion at day 29 between the PROCRIT and placebo groups (46% vs. 48.3%, p=0.34; relative risk 0.95, 95% confidence interval (CI), 0.85, 1.06). In addition, there was no difference between treatment groups in the total number of RBC units transfused through study day 42.

As noted by the authors, the most likely explanation for the lack of transfusion reduction was a change in transfusion practice. In two prior trials in critically ill patients, the PROCRIT group did achieve a reduction in RBC transfusions. In these studies, the mean pre-transfusion Hb concentration was 8.5 g/dL. In contrast in this trial, the mean pre- transfusion Hb concentration observed was 8.0 g/dL and the percentage of patients transfused was lower.

Mortality at study day 29 was significantly lower in the PROCRIT group (Kaplan-Meier (K-M) estimates: 8.5% vs. 11.4%, p=0.02). The mortality benefit with PROCRIT was most apparent in the trauma subgroup (K-M estimates: 3.5% vs. 6.6%, p=0.04). The mortality pattern at day 140 was similar for the overall group (K-M estimates: 14.2% vs. 16.8%, p=0.08) and the trauma subgroup (K-M estimates: 6.0% vs. 9.2%, p=0.08). The adjusted hazard ratios confirmed the mortality findings for trauma patients at days 29 (0.37, 95% CI, 0.19, 0.72) and 140 (0.40, 95% CI, 0.23, 0.69). The increase in Hb at day 29 was greater for patients who received PROCRIT (1.6 plus or minus 2.0 g/dL for patients receiving PROCRIT vs. 1.2 plus or minus 1.8 g/dL for patients receiving placebo, p<0.001).

As expected in a population of critically ill patients, adverse events and serious adverse events were frequent. A total of 690 (94.8%) PROCRIT patients and 680 (94.4%) placebo patients experienced at least one adverse event. Similarly, 44% of PROCRIT pa
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SOURCE Ortho Biotech Products, L.P.
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