May 7, 2008 – Lantheus Medical Imaging initiated CaRES (Contrast Echocardiography REgistry for Safety Surveillance), a multicenter Phase IV observational study that will further evaluate the safety profile of DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension in patients with suboptimal echocardiograms, to explore the safety profile of DEFINITY for which the FDA posted an alert on Oct. 10, 2007.
In post-marketing use, four patients experienced fatal cardiac arrests either during or within 30 minutes of DEFINITY administration; one patient received DEFINITY and underwent a cardiac stress test, two patients had severe congestive heart failure and the fourth was undergoing mechanical ventilation for respiratory failure.
The open-label, nonrandomized registry will be conducted in at least 10 clinical sites in the U.S. and include at least 1,600 patients. The study will gather data on patient characteristics and demographics, indication for the contrast usage, safety monitoring of patients during and after DEFINITY administration and nature and frequency of any adverse events that may occur.
“The CaRES registry was established following discussions with the FDA to further explore the safety profile of DEFINITY as it is used in clinical practice. We believe this is the first large multi-center safety registry of its kind to be performed in the U.S.," said Mark Hibberd, M.D., Senior Medical Director, Lantheus Medical Imaging. "We expect the study to provide the physician community with important information about the safety profile of DEFINITY in patients with suboptimal non-contrast echo studies."
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 agent currently carries the “black box” warning from the FDA. The safety and efficacy of DEFINITY with exercise stress or pharmacologic stress testing have not been established.
For more information: http://www.fda.gov/CDER/drug/InfoSheets/HCP/microbubbleHCP.htm and http://www.nmh.org/nmh/heart/coronarydisease/main.htm