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Lantheus Medical Imaging, Inc.,has announced new data from a Phase 4, open-label safety study evaluating the effect of  DEFINITY Vial.

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced new data from a Phase 4, open-label safety study evaluating the effect of DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension, an echocardiography contrast agent, on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure.

The study demonstrated that administration of DEFINITY did not result in any clinically or statistically significant changes in systemic or pulmonary artery hemodynamic measurements in either patient group. The data were presented on Sunday, June 13, 2010, by Kevin Wei, M.D., Associate Professor of Medicine at Oregon Health & Science University, during the “Contrast Perfusion Imaging in Decision-Making” case-based presentation at the American Society of Echocardiography 21st Annual Scientific Sessions in San Diego.

“Examining changes in pulmonary pressures following the administration of ultrasound contrast imaging agents is an important safety measurement,” said Dr. Wei. “This Phase 4 safety evaluation demonstrated that the administration of DEFINITY produced no changes in pulmonary or systemic hemodynamic parameters, either in patients with normal or increased pulmonary artery pressure at baseline, providing further validation of the safety profile of this agent.”

The primary objective of this study was to evaluate the effect of DEFINITY on pulmonary artery hemodynamics in patients with normal or elevated baseline pulmonary artery pressure who were undergoing right heart catheterization as part of routine clinical evaluation. The study’s secondary objective was to assess the safety and potential immunologic effects of DEFINITY administration in these patients.

The Phase 4, open-label, non-randomized study was conducted at eight sites in the United States and enrolled 34 patients, 32 of whom received DEFINITY. DEFINITY was administered after right heart catheterization had been initiated and pulmonary artery systolic pressure (PASP) and additional baseline measurements had been obtained. Safety assessments, including multiple pulmonary artery hemodynamic measurements and serum blood testing for immune response were conducted up to 60 ± 10 minutes after DEFINITY administration. Patients were contacted up to 24 + 8 hours after the administration of DEFINITY to perform adverse event (AE) monitoring and at 4 + 3 days for serious adverse event (SAE) monitoring.

DEFINITY administration did not result in any clinically or statistically significant changes in systemic and pulmonary artery hemodynamic measurements in the patients with either normal or elevated PASP in the population tested. Overall, DEFINITY demonstrated a positive safety profile and was well tolerated. No deaths, SAEs or other significant AEs occurred during the study. Results of the immunologic tests showed no evidence for hypersensitivity reactions in any patient. Additionally, there were no clinical events that suggested evidence of mast cell activation or hypersensitivity reactions related to DEFINITY administration.

“This study shows that DEFINITY is well tolerated and can be used in patients with normal and elevated PASP without causing abnormalities in pulmonary artery hemodynamics or triggering immunologic changes or hypersensitivity reactions. These findings reinforce the safety of DEFINITY-enhanced echocardiography in routine clinical practice,” said Dana Washburn, M.D., Vice President, Clinical Development and Medical Affairs, Lantheus Medical Imaging, Inc. “This Phase 4 safety study marks Lantheus’ third and final post-approval, FDA-required safety study for DEFINITY, and illustrates that DEFINITY can be used in patients with or without pulmonary hypertension when contrast is needed to enhance suboptimal echocardiograms.”

In 2009, Lantheus completed the first two safety commitments, the CaRES (Contrast echocardiography REgistry for Safety Surveillance) prospective safety registry among 1,053 patients undergoing contrast and a retrospective observational study of safety in 15,798 critically ill patients undergoing DEFINITY echocardiography in the ICU setting.

“Lantheus is the first microbubble ultrasound contrast manufacturer to initiate and complete these important safety studies the FDA has requested of all manufacturers,” said Mark G.

Hibberd, M.D., Ph.D., Senior Medical Director, Medical Affairs and Pharmacovigilance, Lantheus Medical Imaging, Inc. “The results of Lantheus’ studies confirm that DEFINITY can be used when baseline echocardiograms are suboptimal in a broad range of outpatient and inpatient care settings, including those who are critically ill in the ICU setting, and those who have pre-existent pulmonary hypertension.”

Source: Lantheus Medical Imaging