GE Healthcare today announced results from a new study, which showed that patients receiving Visipaque tm (iodixanol) 320mg I/ml reported less discomfort, characterized by heat or cold sensation or pain upon injection, than patients receiving Isovue ® (iopamidol) 370 mg I/ml during peripheral arteriography. As with other iodinated contrast agents, Visipaque is often associated with sensations of discomfort, warmth or pain. The data were presented at the American College of Cardiology’s 63 rd Annual Scientific Session and Expo. 1 “Contrast-induced discomfort is commonly seen in patients undergoing peripheral arteriography,” said Thomas Todoran, M.D., lead author of the study and Assistant Professor of Medicine, Director of Vascular Medicine at Medical University of South Carolina. “Patient discomfort continues to be a challenge, primarily because of potential for body movement that may lead to image degradation. Results from this study showed that Visipaque use led to significantly less patient discomfort, heat or pain when compared to Isovue. The results of this comparative study suggest that Visipaque may be a preferable contrast agent for use in peripheral arteriography.” While this study was not powered to detect a difference in image quality, the number of subjects with image quality rated as excellent was numerically greater in the Visipaque group (86.5%) versus the Isovue group (82.4%), but the difference was not statistically significant. Discomfort impacted image quality in 6.5% of Isovue subject images and in 3.2% of Visipaque subject images. About the Study This prospective, multicenter, randomized, double-blind, parallel group, comparative study evaluated and compared contrast-induced patient discomfort, overall safety and image quality following contrast administration in 253 patients receiving either Visipaque 320mg I/mL or Isovue 370mg I/mL, The study conducted at 13 sites throughout Europe and the United States. Of these, 249 patients (125 Visipaque, 124 Isovue) completed discomfort assessments. Contrast-induced discomfort, specifically coldness, heat or pain, was assessed within 10 minutes following each contrast injection and rated verbally by the patient on a 0-to-10 scale.
The study found administration of Visipaque 320 mg I/mL resulted in less frequent and less severe patient reports of discomfort than did iopamidol 370 mg I/mL, during overall injection, with heat and pain being the major contributors. Specifically:
- Significantly fewer patients receiving Visipaque reported severe discomfort (16.9% vs. 46.4%, p<0.0001), heat (15.3% vs. 36.8%; p<0.0002), and pain (2.4% vs. 23.2%, p<0.0001) than did patients receiving Isovue.
- No difference was observed for other safety parameters between the two groups.
- No significant differences were seen in image quality between the two groups.
For our latest news, please visit http://newsroom.gehealthcare.comImportant Risk and Safety Information About Visipaque™ (iodixanol) Injection Visipaque — NOT FOR INTRATHECAL USE SEVERE ADVERSE EVENTS DUE TO INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media (CM) that are not indicated for such use. These reactions include death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Assure that Visipaque product is not administered intrathecally. INDICATIONS — Intra-arterial (IA): Visipaque Injection (270 mgI/mL) is indicated for IA digital subtraction angiography. Visipaque Injection (320 mgI/mL) is indicated for angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. Intravenous (IV): Visipaque Injection (270 mgI/mL and 320 mgI/mL) is indicated for computed tomography (CT) of the head and body, and excretory urography. Visipaque Injection (270 mgI/mL) is also indicated for peripheral venography. CONTRAINDICATIONS: Visipaque Injection is not indicated for intrathecal use. In pediatric patients, prolonged fasting and administration of a laxative before a Visipaque Injection are contraindicated. WARNINGS: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiocardiographic procedures with CM. Serious or rare fatal reactions have been associated with the administration of iodine-containing CM. Use caution in patients with severely impaired renal function (either alone or combined with hepatic or cardiac disease), severe thyrotoxicosis, myelomatosis, or anuria, especially if administering large doses. Intravascular iodinated CM are potentially hazardous in patients with multiple myeloma or other paraproteinaceous diseases and in patients who are prone to disease-induced renal insufficiency and/or renal failure. Thyroid storm has been reported following intravascular use of iodinated CM in patients with hyperthyroidism or an autonomously functioning thyroid nodule. Use extreme caution administering CM to patients known to have, or are suspected of having, pheochromocytoma. CM may promote sickling in individuals homozygous for sickle cell disease. PRECAUTIONS — General: CMs are associated with risk and increased radiation exposure. Dehydration, Renal Insufficiency, Congestive Heart failure (CHF): Prestudy dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, congestive heart disease, diabetic patients, and others such as those on medications that alter renal function and the elderly with age-related renal impairment. Patients should be adequately hydrated prior to and after intravascular iodinated CM. Dose adjustments in renal impairment have not been studied. Iodinated CM may cross the blood-brain barrier (BBB). In patients where the BBB is known or suspected of disruption, or in patients with normal BBB and associated renal impairment, caution must be exercised in the use of iodinated CM. Patients with CHF receiving concurrent diuretic therapy may have relative intravascular volume depletion, which may affect the renal response to the CM osmotic load. Renal Insufficiency: In patients with significantly impaired renal function, the total clearance of iodixanol is reduced and the plasma half-life is prolonged. In a study of 16 adult patients scheduled for renal transplant, the plasma half-life was 23 hours (normal = two hours). Dose adjustments in patients with renal impairment have not been studied. Visipaque does not bind to plasma or serum protein and can be dialyzed. Immunologic Reactions: Always consider the possibility of a reaction, including serious, life-threatening, fatal anaphylactoid or cardiovascular (CV) reactions. Anesthesia: A higher incidence of adverse reactions has been reported in patients receiving general anesthesia. Venography: Exercise extreme caution during CM injection to avoid extravasation, especially in patients with severe arterial or venous disease. CT: The use of CM may obscure some lesions seen on previous, unenhanced scans. Pediatric Use: Pediatric patients at high risk of adverse reactions during and after administration of CM include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, CHF, or a serum creatinine >1.5 mg/dL. Patients with immature renal function or dehydration may be at increased risk due to prolonged elimination of iodinated CM. The injection rates in small vascular beds and the relationship of the administered volume or concentration of iodinated CM in small neonates, infants, and small pediatric patients have not been established. In pediatric patients <1 year, the relative safety of the volumes injected, the optimal concentrations, and the potential need for dose adjustment because of prolonged elimination half-lives have not been systematically studied. In pediatric patients studied, adverse events were associated with decreasing age and IA procedures . Geriatric Use: While no overall differences in safety or effectiveness were observed in patients >65 years, greater sensitivity regarding some older individuals cannot be ruled out. As Visipaque is substantially excreted by the kidney, the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Nursing Mothers: It is not known whether Visipaque is excreted in human milk; however, many injectable CM are excreted unchanged in human milk. Consideration should be given to temporarily discontinuing nursing. ADVERSE REACTIONS: Serious, life-threatening, and fatal reactions, mostly of CV origin, have been associated with the administration of iodine-containing CM, including Visipaque Injection. Most deaths occur during injection or five to 10 minutes later. Rare reports of anaphylaxis have been documented during postmarketing surveillance. As with other CM, Visipaque is often associated with sensations of discomfort, warmth, or pain. The reported incidence of adverse reactions to CM in patients with a history of allergy is twice that of the general population. Patients with a history of a previous reaction to CM are three times more susceptible than other patients. DRUG INTERACTIONS: Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular CM. Other drugs should not be mixed with Visipaque. OVERDOSAGE: The adverse effects of CM overdose may be life-threatening, affecting mainly the pulmonary and CV systems. Prior to use, please read the Full Prescribing Information for Visipaque Injection. *Isovue ® is a registered trademark of Bracco Diagnostics 1 Todoran T, Rosenberg C, Martinez Rodrigo JJ, et al. Contrast-induced Patient Discomfort: A Comparative Study of Visipaque (Iodixanol) Injection 320 mg I/mL Versus Isovue - 370 (iopamidol Injection 76%) for Peripheral Arteriography. Poster presented at 63 rd Annual Scientific Session and Expo of the American College of Cardiology