Lantheus Medical Imaging, Inc. a worldwide leader in diagnostic imaging,
announced today new data from a retrospective, multicenter, cohort study
of over four million hospitalized patients that shows similar unadjusted
mortality rates for patients receiving DEFINITY® Vial For
(Perflutren Lipid Microsphere) Injectable Suspension enhanced resting
echocardiography exams when compared with patients who did not receive
DEFINITY®. Although the patients that received DEFINITY®
were sicker on average and had a higher baseline mortality risk prior to
the exam, following DEFINITY® administration these same
patients exhibited a 24% reduced risk of mortality over 24 hours
compared to the those patients who received only echocardiography
without the ultrasound contrast agent. These study findings were
published in the December 2008 issue of TheAmerican Journal
of Cardiology.
“As the largest retrospective, observational study to date to examine
the short-term safety profile of perflutren-containing ultrasound
contrast agents, the data highlight the relatively low incidence of
adverse safety reactions associated with DEFINITY® and
demonstrate a significantly lower risk of acute mortality for patients
receiving DEFINITY®-enhanced echocardiograms,” said Mark
Hibberd, M.D., Ph.D., Senior Medical Director, Global Medical Affairs,
Lantheus Medical Imaging, Inc. and co-author on the study. “These study
findings provide the physician community with essential safety
information on the use of DEFINITY®, especially among
hospitalized patients, and provide valuable information on patient
outcomes that bear further investigation.”
The study was designed to assess short-term (one-day) mortality in
hospitalized patients undergoing resting transthoracic echocardiography
both with and without DEFINITY®. The study analyzed more than
4.3 million patients undergoing clinically indicated echocardiography
from January 1, 2002 through October 31, 2007 using the Premier
Perspective Database, the largest U.S. hospital-based, service-level
comparative database providing detailed resource utilization data along
with patients’ primary and secondary diagnosis and procedure codes. Of
this population, 4,242,712 patients received non-enhanced
echocardiograms and 58,254 received contrast-enhanced studies using
DEFINITY®.
One-day mortality rates were 1.08% for patients undergoing non-contrast
studies and 1.06% for patients undergoing DEFINITY® contrast-enhanced
examinations. However, patients receiving DEFINITY® were more
likely to have an increased baseline severity of illness and a higher
pre-study risk of mortality. A multivariate logistic regression analysis
was used to compare 24-hour mortality, controlling for case mix and
clinical covariates. Patients undergoing DEFINITY® -enhanced
echocardiograms had a 24% lower risk adjusted odds ratio for mortality
within one day than those patients who received only echocardiography
without the ultrasound contrast agent.
These findings build on and corroborate a recently published multicenter
retrospective study that also demonstrated no increased mortality in
patients undergoing echocardiography with a contrast agent in comparison
with patients undergoing non-contrast-enhanced examinations (Journal
of the American College of Cardiology, Volume 51, Number 17, 2008).1
In addition, this multicenter analysis was presented in part at a
meeting of the United States Food and Drug Administration Cardiovascular
and Renal Drugs Advisory Committee in June, 2008.
These study findings also confirm the safety profile of ultrasound
contrast imaging agentsand support the implementation of the
recently published American Society of Echocardiography (ASE) Consensus
Statement on the Clinical applications of Ultrasound Contrast Agents in
echocardiography.
“This study is groundbreaking in the echocardiography area, and
represents the largest evaluation of resting echocardiography among
hospitalized patients,” continued Dr. Hibberd of Lantheus. “It is also
the first to evaluate the impact of contrast echocardiography on
survival among hospitalized patients. The results clearly indicate that
there is no additional risk associated with DEFINITY®-enhanced
studies, while in fact those patients that received DEFINITY®
had improved short-term survival when compared to those who received
only transthoracic echocardiograms without DEFINITY®. The
study did not address the reason for this effect. These data provide the
medical community with further clinical evidence of how DEFINITY®
can significantly improve the standard of care for patients undergoing
cardiac evaluations, and we are continuing to explore the role of
DEFINITY® in specialized patient populations such as those in
the ICU and receiving mechanical ventilation."
Don Kiepert, President and CEO, Lantheus Medical Imaging added, “We are
encouraged by these data that further demonstrate the role and clinical
value of DEFINITY®, and believe these findings will answer
any remaining safety questions regarding ultrasound contrast agents.
Lantheus continues to remain committed to providing important safety
information on the use of DEFINITY® in routine clinical
practice.”
About DEFINITY®
Since its launch in 2001, activated DEFINITY® Vial For
(Perflutren Lipid Microsphere) Injectable Suspension has been
administered to over two millionpatients.2 In
patients with suboptimal echocardiograms, DEFINITY® enables
physicians to visualize the borders of the heart more clearly.3,4
In May 2008, Lantheus announced the initiation of CaRES (Contrast
Echocardiography REgistry for Safety Surveillance),
the first multi-center Phase IV observational registry that will further
evaluate the safety profile of DEFINITY® in patients with
suboptimal echocardiograms and provide safety information on the use of
ultrasound contrast agents in routine clinical practice. The open-label,
non-randomized registry is being conducted in more than 10 clinical
sites in the United States and include at least 1,000 patients. The
study will gather data on patient characteristics and demographics,
indication for DEFINITY®’s use,results of safety
monitoring of patientsduring and after DEFINITY®
administration, and the nature and frequency of any adverse events that
may occur.
Important Safety Information about DEFINITY®
Activated DEFINITY® Vial for (Perflutren Lipid Microsphere)
Injectable Suspension is indicated for use in patients with suboptimal
echocardiograms to opacify the left ventricular chamber and to improve
the delineation of the left ventricular endocardial border. The safety
and efficacy of DEFINITY® with exercise stress or
pharmacologic stress testing have not been established.
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred
during or following perflutren-containing microsphere administration.
Assess all patients for the presence of any condition that precludes
DEFINITY® administration (see CONTRAINDICATIONS). In patients
with pulmonary hypertension or unstable cardiopulmonary conditions,
monitor vital sign measurements, electrocardiography and cutaneous
oxygen saturation during and for at least 30 minutes after DEFINITY®
administration (see WARNINGS). Always have resuscitation equipment and
trained personnel readily available.
Activated DEFINITY® should not be administered to patients
with known or suspected cardiac shunts (right-to-left, bi-directional or
transient right-to-left), or hypersensitivity to perflutren. Do not
administer DEFINITY® by intra-arterial injection.
In postmarketing use, uncommon but serious reactions observed during or
shortly following perflutren-containing microsphere administration
included fatal cardiac or respiratory arrest, loss of consciousness,
convulsions, symptomatic arrhythmias (atrial fibrillation,
supraventricular tachycardia, ventricular tachycardia or fibrillation),
hypotension, respiratory distress or cardiac ischemia (see ADVERSE
REACTIONS). The risk for these reactions may be increased among patients
with pulmonary hypertension or unstable cardiopulmonary conditions
(acute myocardial infarction, acute coronary artery syndromes, worsening
or unstable congestive heart failure, serious ventricular arrhythmias or
respiratory failure, including patients receiving mechanical
ventilation). In the absence of these underlying conditions, observe
patients closely during and following DEFINITY®
administration.
Always have cardiopulmonary resuscitation personnel and equipment
readily available prior to DEFINITY® administration
and monitor all patients for acute reactions.
For full prescribing information, please visit www.lantheus.com.
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic
medicine for the past 50 years, is committed to advancing the field of
diagnostic imaging. The company’s proven success in discovering,
developing and marketing innovative medical imaging agents provides an
unparalleled platform from which to bring forward breakthrough new tools
for the diagnosis and management of disease. The company is home to
leading diagnostic imaging brands, including Cardiolite® (Kit
for the Preparation of Technetium Tc99m Sestamibi for Injection),
DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable
Suspension, and TechneLite® (Technetium Tc99m Generator) and
has nearly 700 employees worldwide with headquarters in North Billerica,
Massachusetts, and offices in Puerto Rico, Canada, and Australia. For
more information, visit www.lantheus.com.
1 Wei K, et al. The safety of definity and optison for
ultrasound image enhancement: a retrospective analysis of 78,353
administered contrast doses. J Am Coll Cardiol;51(17):1202-1206.
2 Source: The Echocardiography Monthly Monitor: United
States, October 2001-September 2007, Arlington Medical Resources,
Inc., Malvern, PA.
3 Kitzman DW et al. Efficacy and safety of the novel
ultrasound contrast agent perflutren (definity) in patients with
suboptimal baseline left ventricular echocardiographic images. AM J
Cardiol. 2000; 86: 669-674.
4 Data on file, Lantheus Medical Imaging, Inc.
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