Healthcare Industry News: neuroendocrine tumor
News Release - March 31, 2009
GE Healthcare Announces Data from Phase III Study of AdreView in Heart Failure PatientsORLANDO, Fla.--(HSMN NewsFeed)--GE Healthcare, a unit of General Electric Company (NYSE: GE ), presented results from the ADMIRE-HF study at the American College of Cardiology’s 58th Annual Scientific Session in Orlando, Florida today. The study involved a nuclear imaging test utilizing the imaging agent AdreView™ (Iobenguane I 123 injection) in heart failure patients who are at a higher risk for cardiac death, disease progression, or cardiac arrhythmias.
The ADMIRE-HF study, fully titled “The Prognostic Significance of 123I-mIBG Myocardial Scintigraphy in Heart Failure Patients: Results from the Prospective Multicenter International ADMIRE-HF Trial,” was presented during the “Late-Breaking Clinical Trials VI: Arrhythmias/CHF” session this morning. ADMIRE-HF is the combination of two identical Phase III clinical trials, MBG311 and MBG312, which were conducted in 96 centers across the U.S. and Europe. Nine hundred and sixty four patients with New York Heart Association (NYHA) Class II (82%) and III (18%) heart failure (66% ischemic, 34% non-ischemic) and left ventricular ejection fraction (LVEF) ≤35% (mean 27.1%) underwent early (15 minute) and late (four hour) planar and SPECT myocardial imaging with AdreView. Patients were then observed every six to seven weeks over the course of two years to monitor the patient’s status.1
AdreView, in conjunction with myocardial scintigraphy, was studied in the ADMIRE-HF trial for its ability to evaluate the sympathetic nerves of the heart at the cellular level. The hypotheses were as follows: (1) If these nerves are functioning properly, there is good uptake of AdreView, while if the nerves are damaged or reduced in number, less AdreView is taken up by the heart, and (2) If a patient’s heart nerve function is poor, he or she is at increased risk for heart failure progression and cardiac death. 1
The composite endpoint was the time to first occurrence of NYHA heart failure class progression, a potentially life-threatening arrhythmic event or cardiac death, as determined by an independent adjudication panel. 1
The primary analysis employed a Cox proportional hazards model to compare outcomes in subjects with heart/mediastinum ratios (H/M) of <1.60 and ≥1.60 on late planar imaging. A multivariable Cox proportional hazards analysis incorporated imaging and clinical variables into a prediction model for adverse cardiac events. 1
Two hundred thirty eight patients (25%) experienced adverse cardiac events during a median follow-up of 17 months; first events were heart failure progression in 163 subjects, arrhythmic events in 51 and 24 cardiac deaths. An additional 29 cardiac deaths occurred as later events. Two year event-free survival was 85% in patients with H/M≥1.60 compared with 63% for those with H/M<1.60 (p=.001). Fifty-one cardiac deaths occurred in the low H/M group compared to two in the high H/M group and the negative predictive value of a high H/M for cardiac death over two years was 98.2%.1
“These data suggest that AdreView imaging may make it possible to assess the nerves of the heart, which cannot be done using tests such as echocardiograms and x-rays,” said Arnold F. Jacobson, M.D., Ph.D., Head, Cardiac Center of Excellence, GE Healthcare and lead investigator of the study. “This ability would go beyond what can be determined from evaluating a patient’s symptoms and physical limitations by providing insight into the heart’s function at the molecular level.”
The results from the ADMIRE-HF study have not been reviewed by the Food and Drug Administration (FDA), and any conclusions that may be drawn regarding the safety and efficacy of AdreView are dependent upon the outcome of FDA’s regulatory review.
“The ADMIRE-HF study data suggest that use of this imaging test may provide a better understanding of a patient’s heart function and the risk that it may worsen over time, which is particularly important for heart failure patients,” said Dr. Jacobson. “This new information, in conjunction with currently available tests, may help clinicians better understand the severity of their patient’s condition and thereby aid in their management decisions.”
According to the American Heart Association and the European Society of Cardiology, 5.7 million Americans and 14 million Europeans suffer from heart failure.2, 3 Cardiovascular disease in all its forms claims about as many lives each year as cancer, chronic lower respiratory diseases, accidents and diabetes combined. Patients who have previously suffered from heart failure have a sudden death rate that is six to nine times greater than the general population.2
As noted above, Dr. Jacobson, the lead investigator of the ADMIRE-HF study, is an employee of GE Healthcare.
AdreView™ (Iobenguane I 123 Injection) is a molecular imaging agent. GE Healthcare began developing AdreView in 2004, and the agent was granted orphan-drug status by the Food and Drug Administration (FDA) in December 2006. In September 2008, AdreView was approved by the FDA for the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. In the United States, it is not currently approved for use in assessing the functional integrity of the cardiac sympathetic innervation.
AdreView is approved in Germany, France, Great Britain, Spain, Belgium, Holland, Denmark, and Norway for the functional assessment of the cardiac sympathetic innervation.
Important Safety Information for AdreView
Hypersensitivity reactions have followed AdreView administration. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration. AdreView contains benzyl alcohol (10.3 mg/mL) which may cause serious reactions in premature or low birth-weight infants. Patients with severe renal impairment may have increased radiation exposure and decreased quality of AdreView images. Failure to block thyroid iodine uptake may result in iodine 123 accumulation in the thyroid. Drugs which block norepinephrine uptake or deplete norepinephrine stores may decrease AdreView uptake in neuroendocrine tumors. When medically feasible, stop these drugs before AdreView administration and monitor patients for withdrawal signs and symptoms.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging helps clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
GE is a diversified global infrastructure, finance and media company that is built to meet essential world needs. From energy, water, transportation and health to access to money and information, GE serves customers in more than 100 countries and employs more than 300,000 people worldwide. GE is Imagination at Work. For more information, visit the company's Web site at http://www.ge.com.
1 Jacobson A. The Prognostic Significance of 123I-mIBG Myocardial Scintigraphy in Heart Failure Patients: Results from the Prospective Multicenter International ADMIRE-HF Trial. Presented at: the 58th Annual Scientific Session of the American College of Cardiology (ACC), 29-31 March 2009. Abstract No. 09-LB-65168-ACC.
2 American Heart Association. Heart Disease and Stoke Statistics, 2009 Update.
3 European Society of Cardiology. Myths and facts about heart failure. Accessed March 24, 2008. http://www.heartfailurematters.org/English_Lang/UnderstandingHeartFailure/Pages/Mythsaboutheartfailure.aspx.
Source: GE Healthcare
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