News | June 15, 2010

Contrast Agent Demonstrates Positive Safety Profile

June 15, 2010 – A new study evaluating the safety of an echocardiography contrast agent found that the agent did not have a significant effect on patients’ pulmonary pressures. The findings, concerning the contrast agent Definity Vial For (Perflutren Lipid Microsphere) Injectable Suspension, were presented on June 13 at the American Society of Echocardiography Annual Scientific Sessions in San Diego.

Kevin Wei, M.D., associate professor of medicine at Oregon Health & Science University, presented the data from the phase 4, open-label safety study by Lantheus Medical Imaging Inc. on the effect of Definity 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.

“Examining changes in pulmonary pressures following the administration of ultrasound contrast imaging agents is an important safety measurement,” said 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.”

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, serious adverse events (SAE) or other significant adverse events (AE) 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.

References
1 Kitzman, D.W. et al. “Efficacy and safety of the novel ultrasound contrast agent perflutren (Definity) in patients with suboptimal baseline left ventricular echocardiographic images.” American Journal of Cardiology. 2000; 86: 669-674.
2 Data on file, Lantheus Medical Imaging Inc.
3 Source: The Echocardiography Monthly Monitor: U.S. Editions, 2002 - 2009, Arlington Medical Resources Inc., Malvern, PA.
4 Mulvagh, S.L., et al. “Contrast Echocardiography: Current and future applications.” Journal of the American Society of Echocardiography 2000; 13:331-42.
5 Waggoner A.D., et al. “Guidelines for the cardiac sonographer in the performance of contrast echocardiography.” Journal of the American Society of Echocardiography. 2001: 417-420.
6 Edited by Scott D. Solomon, M.D., "Essential Echocardiography, A Practical Handbook with DVD." Humana Press; 2007 Chapter 5: Ventricular Systolic Function, P113.
7 Shaw L.J., et al. “Clinical and economic outcomes assessment with myocardial contrast echocardiography.” Heart 1999; 82(Suppl III): III16-III21.

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