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| Published Study Demonstrates Lower Serum Creatinine Levels After Contrast Media Administration | |||
| 16 Jul 2008
, Princeton, NJ.
: GE Healthcare’s iodixanol, an isosmolar contrast medium, shows lower incidence of elevated serum creatinine (SCr) or decreased glomerular filtration rate (GFR) than iopromide, concluded a study written by a team of physicians and researchers at the Medical University of South Carolina, and published in Radiology, a peer-reviewed journal for the field of radiology. The study included 117 patients with decreased renal function, defined as SCr>1.5 mg/mL or GFR<60mL/minute. Each patient underwent contrast-enhanced computed-tomography (CT) studies. Sixty-one patients were administered iodixanol, while 56 were administered iopromide. The study measured changes in SCr levels and GFR at plus one, two, and three days post-CT and then monitored outcomes at 30 and 90 days. Fewer patients administered iodixanol showed an SCr increase of 25% or greater, 8.5% vs. 28% respectively. No patients in either group showed a contrast media related adverse event at the 30- or 90-day follow-up. There was a clinically-relevant GFR reduction of 5mL/min in significantly more patients in the iopromide group than in the iodixanol group; 42.3% vs. 24.1%. The study concluded that while intravenous contrast material application in high-risk patients is unlikely to be associated with permanent adverse outcomes, SCr levels after contrast material administration are lower in the iodixanol group than in the iopromide group. The authors noted their findings may differ from other recently published studies on the topic. According to the text of the study, “Our [the authors] systematic serial assessment of SCr level and GFR over 3 days after CM [contrast media] administration may have been more sensitive to detect SCr-level changes compared with the single sampling at a variable interval (48-72 hours) after contrast medium administration in the prior investigation. Considering that in most patients with decreased renal function, the SCr will peak in the first 72 hours after CM administration, multiple measures may provide greater accuracy regarding SCr dynamics.” ”This study confirms the favorable safety profile of iodixanol in patients undergoing CT scans who may be at-risk for nephropathy,” said Dr. Richard Vitti, Associate Director Medical & Professional Services in GE Healthcare. ABOUT IODIXANOL, SELECT SAFETY INFORMATION VISIPAQUE had a trend toward fewer patient reports of moderate or severe pain or warmth; however, whether or not this is related to the dose, rate of administration, site of injection, or concentration has not been determined. NOT FOR INTRATHECAL USE. All nonionic, iodinated contrast media currently available inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. No iodinated contrast medium available in the U.S. has been approved by the FDA for use in CT angiography or cardiac CT procedures. For Full Prescribing Information, please go to http://md.gehealthcare.com/shared/pdfs/pi/visipaq.pdf. 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 and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their 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. Headquartered in the United Kingdom, GE Healthcare is a $17 billion 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 website at www.gehealthcare.com. |
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