Safety assessment of the use of perflenapent emulsion for contrast enhancement of echocardiography and diagnostic radiology ultrasound studies

Purpose : The studies were undertaken to assess the safety of the use of perflenapent emulsion (EchoGen ® , SONUS Pharmaceuticals, Bothell, Wash.) for contrast enhancement of echocardiography and radiology ultrasound studies. Materials and methods : In all, 1,001 patients or subjects were enrolled in 21 clinical studies. Clinical laboratory tests, pulse oximetry, vital signs, and electrocardiograms (ECGs) were obtained in 818 patients before and after administration of perflenapent emulsion and active control [5% sonicated human albumin, (Albunex ® , Molecular Biosystems, Inc., San Diego, Calif.)] or placebo (saline) to determine mean changes from baseline. Adverse event rates were monitored following administration of perflenapent emulsion in 743 patients and placebo in 151 patients. Results : No clinically significant abnormalities in clinical laboratory, pulse oximetry, vital signs, or ECG evaluations were observed. Values following administration of perflenapent emulsion were comparable with those following placebo or active control. Perflenapent emulsion (50/743; 6.7%) was comparable with placebo (4/151; 2.6%) in the overall incidence of adverse events considered related to the test article. Adverse events that occurred with a frequency of ≥ 1% within 30 min after perflenapent emulsion administration were vasodilation and taste aberration. Adverse events which were mostly mild to moderate in intensity, began within 10 to 20 min after administration, and resolved spontaneously within 10 to 20 min. Conclusion : Perflenapent emulsion is generally well tolerated in patients undergoing echocardiography and ultrasound of other target organs.