Hospira's Precedex(R) Phase IV Study Published in the Journal of the American Medical Association
02 Fevereiro 2009 - 2:43PM
PR Newswire (US)
- Precedex-Sedated Patients Studied For Greater Than 24 Hours in
ICU - 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 percent in Precedex-treated patients vs. 76.6
percent in midazolam-treated patients. Median time to removal from
mechanical ventilation was 3.7 days in the Precedex-treated
patients vs. 5.6 days in the midazolam-treated patients, a
difference of 44 hours. Precedex-treated patients were more likely
to develop bradycardia, or slow heartbeat, but had a lower
likelihood of tachycardia (fast heartbeat) or hypertension that
required treatment. The study design used in this phase IV trial
incorporated new standard elements of sedation practice, including
a light-to-moderate sedation target, delirium assessment, and study
drug titration or interruption every four hours and as part of a
daily arousal assessment. "This multicenter study is one of the
largest to compare two different sedatives for use in the ICU in a
randomized and blinded design," said Richard R. Riker, M.D.,
director of critical care research, Division Pulmonary and Critical
Care Medicine, Maine Medical Center. "Patients who received
Precedex were extubated sooner and had a lower prevalence of
delirium. I expect that patients requiring long-term sedation,
their families and healthcare providers will welcome the results of
this trial." There are more than 5 million patients treated
annually in the ICU(1). In 2003, there were nearly 300,000
prolonged mechanical ventilation discharges in the United States at
an annual aggregated hospital cost of more than $16 billion. At a
cost of more than $1,500 per patient-day(2), mechanical ventilation
represents a significant contribution to overall expenses in the
intensive care setting and drives a disproportionate share of
resource utilization. Providing sedation for patient safety and
comfort is an integral component of bedside care for nearly every
patient in the ICU, and practice guidelines for sedation in the ICU
have identified the need for well-designed randomized trials
comparing the effectiveness of different sedative agents for
important clinical outcomes. "Through this clinical research for
Precedex, Hospira is working to provide nurses, physicians and
pharmacists with data to support a potential new sedation strategy
for management of these complex and critically ill patients," said
Paula Bokesch, M.D., global medical director, Global Medical
Affairs - Drug Development, Hospira. "Hospira is committed to the
research and development of products that improve patient care."
Precedex Indications and Safety Information Precedex
(dexmedetomidine hydrochloride) is Hospira's proprietary I.V.
sedative, and it is a relatively selective alpha-2-adrenoceptor
agonist. In the United States, it is the only drug in its class
(alpha-2-agonists) approved for continuous I.V. sedation of
initially intubated and mechanically ventilated patients in the
intensive care setting for use up to 24 hours. It can be used
before, during and after extubation. Due to the known
pharmacological effects, patients should be continuously monitored
while receiving Precedex. Precedex should only be administered by
persons skilled in the management of patients in the intensive care
or operating room setting. Clinically significant bradycardia and
sinus arrest episodes in young, healthy volunteers with high vagal
tone or with different routes of administration including rapid
intravenous or bolus administration have been reported. Hypotension
and/or bradycardia may necessitate intervention and may be more
pronounced in hypovolemic patients and in patients with diabetes
mellitus, chronic hypertension, and the elderly. Co-administration
with other vasodilators or negative chronotropic agents: Use with
caution due to additive pharmacodynamic effects. Transient
hypertension has been observed primarily during the loading dose.
The most common treatment-emergent adverse reactions occurring in
greater than 2 percent of patients in both intensive care unit and
procedural sedation include hypotension, bradycardia, and dry
mouth. About Hospira Hospira, Inc. is a global specialty
pharmaceutical and medication delivery company dedicated to
Advancing Wellness(TM). As the world leader in specialty generic
injectable pharmaceuticals, Hospira offers one of the broadest
portfolios of generic acute-care and oncology injectables, as well
as integrated infusion therapy and medication management solutions.
Through its products, Hospira helps improve the safety, cost and
productivity of patient care. The company is headquartered in Lake
Forest, Ill., and has more than 14,000 employees. Learn more at
http://www.hospira.com/. (1) Society of Critical Care Medicine.
Critical Care Statistics in the United States. Retrieved January 2,
2009. Web site:
http://sccmcms.sccm.org/NR/rdonlyres/1FCD55C6-71B0-48CA-B652-
31EBB61DD202/504/WebStatisticsPamphletFinalJune07.pdf (2) Dasta,
Joseph F., McLaughlin, Trent P., et al. Daily cost of an intensive
care unit day: The contribution of mechanical ventilation. Critical
Care Medicine, 2005; 33(6):1266-1271
http://www.newscom.com/cgi-bin/prnh/20040503/HSPLOGO
http://photoarchive.ap.org/ DATASOURCE: Hospira, Inc. CONTACT:
Media, Dan Rosenberg, +1-224-212-3366, or Financial Community,
Karen King, +1-224-212-2711, both for Hospira, Inc. Web site:
http://www.hospira.com/
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