Study Supports Safety Profile of Diagnostic Heart Ultrasound Contrast Agent

A poster of the results, which was presented at the American Society of Echocardiography (ASE) 22nd annual scientific sessions, held June 2011 in Montreal (Canada), revealed that Optison 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.

The data from this new drug application (NDA) postmarketing commitment study provide additional information to help better determine the risk of cardiovascular reactions associated with the administration of ultrasound contrast agents. "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 (Kansas City, MO, USA; www.saintlukeshealthsystem.org), 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."

This phase 4 single-blind, cross-over, placebo-controlled study compared the effects of Optison and 5% dextrose (control) on PASP and PVR assessed during right heart cardiac catheterization. Optison, developed by GE Healthcare Medical Diagnostics (Little Chalfont, UK), 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. "Clinical results show that ultrasound contrast agents, like Optison, can be a valuable tool to assist in the diagnosis of cardiovascular disease, a leading cause of death for both men and women," said Brian Robinson, MD, medical director, GE Healthcare Medical Diagnostics. "The favorable safety profile of Optison makes it an important diagnostic option for patients with suboptimal echocardiograms."

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 mmHg) or elevated (> 35 mmHg) baseline PASP. Overall, following Optison treatment, average PASP values were about the same as baseline (55.2 mmHg at baseline compared with 55.6 mmHg at 2 minutes after injection, 54.1 mmHg at 6 minutes after injection, and 54.6 mmHg 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 a US Food and Drug Administration (FDA)-approved ultrasound contrast agent available in an easy-to-use formulation, providing the benefits of fast preparation time, ease of use, portability, and flexible dosing. Optison takes less than 60 seconds to prepare and is stable at room temperature for up to 24 hours, allowing for quick access to contrast at the bedside, in the echocardiogram lab or in trauma situations.

The US FDA and GE Healthcare jointly designed this study to evaluate the effect of Optison on pulmonary hemodynamics. In accordance with an NDA postmarketing commitment, this single-blind, two-period cross-over, placebo-controlled clinical study of Optison and 5% dextrose (control) was conducted in 30 subjects, aged 18 years and older, referred for cardiac catheterization for clinical reasons. The primary objective was to compare the effects of Optison and a control solution on PASP and PVR, evaluated by right heart cardiac catheterization techniques. The secondary objective of this study was to perform an overall assessment of the safety of Optison in study subjects.

Related Links:
Saint Luke's Mid America Heart Institute
GE Healthcare Medical Diagnostics