December 15, 2008 - Lantheus Medical Imaging reported that new data from a retrospective, multicenter, cohort study of over four million hospitalized patients showed 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 percent 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 The American 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. 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 percent for patients undergoing non-contrast studies and 1.06 percent 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 percent 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.
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.
For more information: www.lantheus.com