Skip Navigation LinksHome > June 2007 - Volume 35 - Issue 6 > ADDRESS (ADministration of DRotrecogin alfa [activated] in E...
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Critical Care Medicine:
doi: 10.1097/01.CCM.0000266588.95733.63
Feature Articles

ADDRESS (ADministration of DRotrecogin alfa [activated] in Early stage Severe Sepsis) long-term follow-up: One-year safety and efficacy evaluation*

Laterre, Pierre-Francois MD; Abraham, Edward MD; Janes, Jonathan M. FRCP; Trzaskoma, Benjamin L. MS; Correll, Nancy L.; Booth, Frank V. MD

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Abstract

Objective: To demonstrate that drotrecogin alfa (activated) has an acceptable safety profile 1 yr from randomization.

Design: One-year follow-up of patients participating in a placebo-controlled clinical study of drotrecogin alfa (activated) in severe sepsis patients at low risk of death (the ADDRESS study).

Setting: The study was conducted at 516 hospitals in 34 countries.

Patients: The study included 2,640 patients.

Interventions: One-year follow-up was performed as an addendum to the placebo-controlled ADDRESS study. Treatment groups were compared using the chi-square test and Kaplan-Meier estimates.

Measurements and Main Results: Survival status at 1 yr was obtained for 90% of patients enrolled in the study (n = 2,376). The difference in mortality rate between drotrecogin alfa (activated) and placebo patients was numerically smaller at 1 yr (34.2% and 34.0%, respectively, p = .94) than at 28 days (18.5% and 17.0%, respectively, p = .34). In the subgroups defined by organ dysfunction class (single or multiple) and Acute Physiology and Chronic Health Evaluation II score (<25 or ≥25), the differences in mortality rate between treatment groups at 1 yr were consistent with those observed at 28 days; no significant differences in mortality rates between treatment groups were observed. No additional serious adverse events were reported during the period between hospital discharge and 1 yr.

Conclusions: No increased risk of death or evidence of harm at 1 yr was associated with drotrecogin alfa (activated) administration in patients with severe sepsis at lower risk of death.

© 2007 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins

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