Lantheus Medical Imaging, Inc. (North Billerica, MA, USA), a developer, manufacturer, and distributor of diagnostic imaging agents, announced the publication of the results from the CaRES multicenter safety registry for its ultrasound imaging agent Definity vial for (perflutren lipid microsphere) injectable suspension. The CaRES (Contrast Echocardiography REgistry for Safety Surveillance) study’s findings were published in the July 2012 issue of the Journal of the American Society of Echocardiography.
“To our knowledge, the CaRES study is the first multicenter prospective registry to evaluate the safety of Definity in a large and diverse patient population and now provides physicians a measure for understanding the safety and tolerability of Definity use in a real-world, routine clinical setting,” said Mark Hibberd, MD, PhD, senior medical director, global medical affairs, Lantheus Medical Imaging. “Across a broad range of patients with significant preexisting cardiopulmonary conditions and suboptimal baseline echocardiograms, Definity demonstrated a consistently strong safety profile. The conclusions of this study, coupled with the recommendations for the use of contrast echocardiography by the American Society of Echocardiography, reinforce the important role of Definitityin cardiac imaging.”
The prospective, open-label, nonrandomized registry study was designed to assess the risk of adverse clinical events occurring within 30 minutes of Definity administration in a routine clinical setting. Among the 1,053 patients who completed the study, no deaths, life-threatening events, serious adverse events, or serious anaphylactoid (allergic) reactions were reported during or after administration. The overall adverse event (AE) rate was 10.8%, and drug-related AE rate was 3.5%. Of the AEs that occurred during or after the agent’s administration, a substantial majority (96.5%) were mild to moderate in intensity.
The CaRES study complements another recently published study on the hemodynamic effects of Definitiyin patients with pulmonary hypertension. Published in the May 2012 issue of the Journal of the American Society of Echocardiography (Wei et al., 2012), this prospective study evaluated 32 patients, half of whom had elevated baseline pulmonary artery systolic pressures. The study found that Definity administration did not result in any clinically consequential changes in systemic and pulmonary artery hemodynamic measurements among patients with either normal or elevated pulmonary artery pressure. Moreover, no serious or fatal adverse events occurred. Overall, the agent demonstrated a positive safety profile, and was well tolerated.
Both the CaRES study and the pulmonary hypertension study were developed in conjunction with the US Food and Drug Administration (FDA) in 2008 as part of a risk assessment program for perflutren-based ultrasound contrast agents, such as Definity. “The CaRES study builds on a large and growing body of peer-reviewed literature and a decade of real-world experience which support a well-characterized and favorable benefit-risk profile for Definity,” added Dana Washburn, MD, chief medical officer at Lantheus Medical Imaging.
The CaRES study enrolled a total of 1,060 patients at 15 clinical sites in the United States. Of these enrollees, 1,053 received at least one dose of the contrast agent and completed the study.
Definity vial for injectable suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms. Since its launch in 2001, activated Definitity has been administered to more than 3.5 million patients.
Source:
medimaging.net
