Study Supports Optison’s Safety in Heart Ultrasounds

Optison, a diagnostic ultrasound contrast agent for use in improving echocardiograms, did not significantly affect pulmonary arterial systolic pressure (PASP) or pulmonary vascular resistance (PVR) compared to baseline in patients with normal or elevated pulmonary arterial systolic pressure, a new study has found.

The study, published in the American Journal of Echocardiography and presented Monday at the American Society of Echocardiography 22nd Annual Scientific Sessions in Montreal, was jointly designed by the U.S. Food and Drug Administration and GE Healthcare to satisfy an FDA new drug application post-marketing commitment. The aim was  to evaluate the effect of Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) on pulmonary hemodynamics.

The phase 4 single-blind, two-period cross-over, placebo-controlled clinical study considered Optison and a 5 percent dextrose control. It was conducted with 30 adults who had been referred for cardiac catheterization. The main goal was to compare the effects of Optison and a control solution on PASP and PVR, assessed by right heart cardiac catheterization techniques. The secondary aim was to perform an overall assessment of the safety of Optison in study subjects.

Researchers concluded that there were no clinically meaningful changes in pressure and resistance in the pulmonary arteries following intravenous injection of 0.5 mL of Optison in patients with either normal (<35 mm Hg) or elevated (>35 mm Hg) baseline PASP. Overall, following Optison treatment, average PASP values were about the same as baseline (55.2 mm Hg at baseline compared with 55.6 mm Hg at 2 minutes after injection, 54.1 mm Hg at 6 minutes after injection, and 54.6 mm Hg at 10 minutes after injection). Similar results were observed in each treatment arm (Optison followed by control or control followed by Optison) and in both treatment arms combined. There were no serious adverse events.

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.
 
“These results should provide encouragement for patients and clinicians about the safety and tolerability of Optison,” said Michael Main, MD of Saint Luke’s Mid America Heart Institute, lead author of the study. “Optison provides a quick and convenient contrast option for improving suboptimal echocardiograms of the heart’s left ventricle in patients.”

The study:
Main M, Grayburn P, et al. A Phase 4 Placebo Controlled, Single Blind, Cross Over Study to Evaluate the Effect of Optison™ on Pulmonary Artery Systolic Pressure and Pulmonary Vascular Resistance as Measured By Right Heart Catheterization. Journal of the American Society of Echocardiography. 2011: B30.