PRINCETON, NJ, June 13, 2011 - Today, GE Healthcare Medical Diagnostics announced results of a study that evaluated the cardiopulmonary safety of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in improving suboptimal echocardiograms. A poster of the results, which was presented at the American Society of Echocardiography (ASE) 22nd Annual Scientific Sessions, showed 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 NDA post-marketing commitment study provide additional information to help better understand the risk of cardiovascular reactions associated with the administration of ultrasound contrast agents.i
"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."
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.i 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.ii
"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 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. i
Optison is an 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. ii The recommended dose is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed, but the total dose should not exceed 5 mL over 10 minutes or 8.7 mL in any one patient study.ii 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.ii
About the Study
The US FDA and GE Healthcare jointly designed this study to evaluate the effect of Optison on pulmonary hemodynamics. In accordance with an NDA post-marketing 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, assessed 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. Subjects were stratified based on a screening PASP obtained by echocardiography within 30 days prior to study drug administration as follows: Stratum 1: Normal PASP (=35 mm Hg) or Stratum 2: Elevated PASP (>35 mm Hg). Within each stratum, subjects were randomized to 1 of 2 treatment arms as follows: Arm A: Single IV injection of 0.5 mL Optison, followed by single intravenous (IV) injection of 0.5 mL 5% dextrose or Arm B: Single IV injection of 0.5 mL 5% dextrose, followed by single IV injection of 0.5 mL Optison.i
IMPORTANT RISK AND SAFETY INFORMATION ABOUT OPTISON
BOXED WARNING: Serious Cardiopulmonary Reactions: Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
Assess all patients for the presence of any condition that precludes Optison administration.
In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after Optison administration.
Always have resuscitation equipment and trained personnel readily available.
INDICATIONS: 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 or pharmacologic stress testing have not been established. CONTRAINDICATIONS: Do not administer Optison to patients with known or suspected (1) Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or (2) Hypersensitivity to perflutren, blood, blood products or albumin. Do not administer Optison by intra-arterial injection.
WARNINGS: Anaphylactoid Reactions: Postmarketing reports of acute anaphylactoid reactions including shock, bronchospasm, upper airway swelling, loss of consciousness, urticaria and pruritus, have occurred in patients with no prior exposure to perflutren-containing microsphere products. Monitor all patients for signs and symptoms of anaphylactoid reactions. High Ultrasound Mechanical Index: High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The safety of Optison at mechanical indices greater than 0.8 and the safety of Optison with the use of end-systolic triggering have not been evaluated.
PRECAUTIONS: General: Optison contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease and Creutzfeldt-Jakob disease (CJD), no cases of which have ever been identified for albumin. Pregnancy: Adequate or well-controlled studies were not conducted in pregnant women. Optison should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when Optison is administered to a nursing woman. Pediatric Use: Safety and efficacy have not been established in pediatric patients, or in patients with congenital heart disease.
ADVERSE REACTIONS: The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Postmarketing Experience: Fatal cardiac arrests and other serious, but non-fatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.
Prior to Optison administration, please read the Full Prescribing Information.
ABOUT GE HEALTHCARE:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.
Global PR Manager, GE Healthcare, Medical Diagnostics
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