GE Healthcare: Patient Preference For Omnipaque(TM) (Iohexol) Highlighted In First Head-To-Head Taste Test of Oral Contrast Agents

PRINCETON, N.J., Nov. 10, 2010 /PRNewswire/ -- Results from the first head-to-head taste test of oral contrast agents indicate a significantly greater preference for diluted iohexol (Omnipaque) than for diluted diatrizoate sodium (Gastroview) among patients undergoing abdominal-pelvic computed tomography (CT) scanning. The study results, which appear in the current issue of the American Journal of Roentgenology (AJR)(1), may have important implications for improving the patient imaging experience and enhancing compliance with oral contrast media consumption, according to the investigators.

“Our study showed a statistically significant taste preference for the low-osmolar contrast agent iohexol over the high-osmolar diatrizoate sodium, with no significant differences between agents in terms of side effects or bowel opacification,” said Michelle M. McNamara, MD, diagnostic radiologist and assistant professor at the University of Alabama-Birmingham, and lead author of the AJR paper. “The better taste with iohexol should improve patient compliance with drinking the necessary amount of contrast medium and improve overall satisfaction with the radiology experience.”

Dr. McNamara and colleagues conducted a prospective, double-blinded study in which 300 adult patients undergoing routine abdominal-pelvic CT were randomized to receive either iohexol (n=149) or diatrizoate sodium (n=151). Patients graded the taste of the contrast agents using a five-point Likert scale (-2: dislike very much; -1: dislike moderately; 0: neither like nor dislike; +1: like moderately; +2: like very much). As a secondary objective, CT images were graded for bowel opacification by two blinded abdominal radiologists. Investigators also gathered data on side effects.

A total of 233 patients (81%) preferred iohexol, compared to 54 patients (19%) who preferred diatrizoate sodium (p<0.001). Ten patients expressed no preference, and three patients did not complete the taste comparison study. The radiologists observed no difference in bowel opacification between the two oral contrast agents (p=0.27). The incidence of side effects was low in both groups of patients, with no significant difference between groups (p=0.352).

“Receiving an oral contrast agent is often the least pleasant part of the radiology experience for a patient,” added Dr. McNamara. “Patients often complain of an unpleasant taste, and many experience gastrointestinal side effects such as nausea and vomiting. This may result in decreased satisfaction with the procedure and poor compliance with oral contrast dosing.”

About Omnipaque for Oral Use

Omnipaque is a world-leading contrast agent for X-ray and has been used in more than 350 million patients worldwide(2). Its indications for oral use include arthrography, examination of the gastrointestinal (GI) tract, endoscopic retrograde pancreatography and cholangiopancreatography, herniography and hysterosalpingography. Omnipaque is the only nonionic, low osmolar contrast medium indicated for oral use(3).

Important Risk and Safety Information About the Oral Use of Omnipaque

INDICATIONS - Oral/Body Cavity Use: Adults:Omnipaque 350 is indicated for arthrography and oral pass-thru examination of the gastrointestinal (GI) tract. Omnipaque 300 is indicated for arthrography and hysterosalpingography. Omnipaque 240 is indicated for arthrography, endoscopic retrograde pancreatography and cholangiopancreatography, herniography, and hysterosalpingography. Children:Omnipaque 300 is indicated for examination of the GI tract. Omnipaque 240 is indicated for examination of the GI tract. Omnipaque 180 is indicated for examination of the GI tract. Omnipaque diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated for voiding cystourethrography. Oral/IV Use: Oral Omnipaque diluted to concentrations from 9 mgI/mL to 21 mgI/mL administered orally in conjunction with Omnipaque 240 and 300 administered intravenously is indicated for use in contrast-enhanced computed tomography of the abdomen.

CONTRAINDICATIONS - Omnipaque should not be administered to patients with a known hypersensitivity to iohexol.

WARNINGS: Oral /Intravascular Use: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Omnipaque should be used with extreme care in patients with severe functional disturbances of the liver and kidneys, severe thyrotoxicosis, or myelomatosis. Diabetics with a serum creatinine level above 3 mg/dL should not be examined unless the possible benefits of the examination clearly outweigh the additional risk. Omnipaque is not recommended for use in patients with anuria. Contrast media are potentially hazardous in patients with multiple myeloma or other paraproteinemia. Ionic contrast media, when injected intravenously or intra-arterially, may promote sickling in individuals who are homozygous for sickle cell disease. Administration of contrast to patients known or suspected of having pheochromocytoma should be performed with extreme caution and the dose injected should be kept to an absolute minimum. The patient’s blood pressure should be assessed throughout the procedure and measures for the treatment of hypertensive crisis should be readily available. Reports of thyroid storm following the use of iodinated, ionic contrast media in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Urography should be performed with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.

PRECAUTIONS-General: Patients should be well hydrated prior to and following administration of any contrast medium. The possibility of a reaction, including serious, life threatening, fatal, anaphylactoid, cardiovascular or central nervous system reactions, should always be considered. The possibility of an idiosyncratic reaction in susceptible patients should always be considered. The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies. After parenteral administration of a contrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred. Renal Impairment: Use in patients with hepatorenal insufficiency only if the possibility of benefit clearly outweighs the additional risk. Diabetics: Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible non-diabetic patients (often elderly with preexisting renal disease) following excretory urography. Congestive Heart Failure (CHF): The potential transitory increase in the circulatory osmotic load in patients with CHF requires caution during injection. These patients should be observed for several hours following the procedure to detect delayed hemodynamic disturbances. General anesthesia may be indicated in the performance of some procedures in selected adult patients; however, a higher incidence of adverse reactions has been reported in these patients. Angiography should be avoided whenever possible in patients with homocystinuria, because of the risk of inducing thrombosis and embolism. Selective coronary arteriography should be performed only in those patients in whom the expected benefits outweigh the potential risk. Repeat Procedures: If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. Nursing Mothers: It is not known to what extent iohexol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women. Bottle feedings may be substituted for breast feedings for 24 hours following administration of Omnipaque. Pediatric Use: Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

ADVERSE REACTIONS - Oral Use is associated with mild transient diarrhea, especially following high concentrations and volumes which may result in hypovolemia. Plasma fluid loss may be sufficient to cause a shock-like state that, if untreated, could be dangerous, especially in elderly, cachectic patients of any age and infants and small children. General Reactions to Contrast Media: Serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of all iodine-containing contrast media. Aseptic meningitis syndrome has been reported rarely. Profound mental disturbances have been reported rarely, usually consisting of various forms and degrees of aphasia, mental confusion, or disorientation. The onset is usually at 8 to 10 hours and lasts for about 24 hours, without after effects. Rarely, persistent though transitory weakness in the leg or ocular muscles has been reported. Peripheral neuropathies have been rare and transitory. In general, the reactions which are known to occur upon parenteral administration of iodinated contrast agents are possible with any nonionic agent. The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur. The injection of contrast media is frequently associated with the sensation of warmth and pain, especially in peripheral angiography.

Prior to Omnipaque administration, please read the Full Prescribing Information.

About GE Healthcare

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SOURCE GE Healthcare