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Hospira's Precedex(R) Phase IV Study Published in the Journal of the American Medical Association
Date:2/2/2009

LAKE FOREST, Ill., Feb. 2 /PRNewswire-FirstCall/ -- The Journal of the American Medical Association (JAMA) has published study results demonstrating Hospira, Inc.'s (NYSE: HSP) alpha-2 agonist Precedex (dexmedetomidine hydrochloride) for intravenous sedation provides comparable effectiveness to commonly used gamma-aminobutyric acid (GABA)-agonist midazolam for greater-than-24-hour sedation of mechanically ventilated patients in the intensive care unit (ICU).

According to the journal article, study results also showed that patients sedated with Precedex were removed from mechanical ventilation almost two days earlier, and the prevalence of delirium in Precedex-treated patients was 22.6 percent less than in patients treated with midazolam. These study conclusions appear in the Feb. 4 issue of JAMA.

The prospective, double-blind, randomized, multinational, comparator Phase IV trial was conducted from March 2005 through August 2007 and involved 375 medical/surgical ICU patients expected to require mechanical ventilation for more than 24 hours. As measured using the Richmond Agitation-Sedation Scale (RASS), there was no difference between Precedex and midazolam in time at targeted sedation level, the study's primary endpoint. Patients in the Precedex group spent 77.3 percent of the time within the target RASS range, while patients in the midazolam group spent 75.1 percent of the time in the target range. These results were based on the intent-to-treat population. This trial forms the basis of a supplemental NDA that has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval for the use of Precedex for sedation of patients beyond 24 hours in the intensive care setting.

According to the article published in JAMA, the incidence of delirium during treatment among patients was 54 per
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SOURCE Hospira, Inc.
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