Comparative Toxic Effects of Iobitridol and Iohexol on the Kidney

Wasaki, Masahiko; Kawamura, H.; Sugimoto, Jiro; Shimada, Masayuki; Satoh, Y.; Tanaka, Eiji; Gemba, Munekazu

doi:10.1097/00004424-199807000-00003

Cited by 12 publications

(6 citation statements)

References 27 publications

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“…The observation that female patients in this study suffered significantly more adverse events than males is likely to be due to a higher prevalence of allergies in females. Since most published data on CM involved very low numbers of patients [2][3][4][5] , a prediction on the clinical safety of CM in a large patient population can only be made with caution. The rate of serious adverse events in our larger multicentre study population was 0.002%.…”

Section: Discussionmentioning

confidence: 99%

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Intravenous Contrast Media in Uroradiology: Evaluation of Safety and Tolerability in Almost 50,000 Patients

et al. 2006

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Ojective: To evaluate the frequency of adverse events and possible risk factors after the administration of an intravenous contrast medium (CM), iobitridol, in a large multicentre postmarketing surveillance study. Subjects and Methods: A total of 49,975 patients undergoing intravenous urography were included in this study. A water-soluble, non-ionic CM (iobitridol, 1 ml/kg body weight) was administered. Age, sex, indication for the actual examination and adverse events were documented. Also, high-risk patients were identified. Results: Of the 49,975 patients, 28,336 (56.7%) were males and 21,639 (43.3%) females. Indications for urography were mainly urolithiasis (39.1%), inflammatory diseases (25.6%) and tumours (13.9%). Additionally, 7.4% were risk patients: 1.9% with creatinine >1.5 mg/dl (0.1% were on haemodialysis); 0.8% had a history of previous allergic reactions to CM, 3.7% pre-existing asthma or allergies and 2% other risk factors against CM examination. Only 0.9% of the patients experienced acute adverse events that were non-serious and transient. Less than 0.1% of the patients experienced vomiting, dizziness or cardiovascular problems. Only 1 patient developed an anaphylactic shock but recovered fully under treatment. A χ² analysis revealed that adverse reactions occurred in patients with pre-existing renal insufficiency or allergies. Significantly more females had contrast-agent-related symptoms compared to men. Patients undergoing urography for urolithiasis had significantly fewer symptoms compared to patients with other indications. Conclusion: Iobitridol is clinically safe and well tolerated in urography as demonstrated in this study of a large patient population, producing mainly minor symptoms as adverse events. However, caution is advised when administering iobitridol to high-risk patients.

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Section: Discussionmentioning

confidence: 99%

“…Low-osmolar CM are also better tolerated by the patient than high-osmolar substances, especially with regard to non-serious adverse events [2][3][4] . Iobitridol is a tri-iodinated low-osmolar non-ionic CM that exhibits excellent tolerability and low toxicity in intravenous urography and has been approved in Germany since 1996 [5,6] .…”

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confidence: 99%

Intravenous Contrast Media in Uroradiology: Evaluation of Safety and Tolerability in Almost 50,000 Patients

et al. 2006

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“…The iobitridol molecule is characterised by a high level of 3D stability of the hydrophilic groups around the lipophilic tri-iodinated benzene ring. The results of preclinical, toxicological, and clinical trials can be found in a supplement of "Acta Radiologica" dedicated to this topic [8] and various other international journals [9,10,11,12]. This article presents the results of a postmarketing surveillance study based on the data of a total of 61,745 patients having received this contrast medium.…”

Section: Contrast Medium Injectionmentioning

confidence: 99%

Results of the safety and efficacy of iobitridol in more than 61,000 patients

Petersein

Peters²,

Wolf

et al. 2003

European Radiology

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We present results of a postmarketing surveillance study with iobitridol (Xenetix, Sulzbach, Germany) in more than 61,000 patients from 1996 until 2000. The purpose of this study was the assessment of safety and diagnostic efficacy of the non-ionic contrast agent iobitridol in the setting of a post-marketing surveillance study. Iobitridol (Xenetix) has been registered in Germany since 1996. Between 1996 and 2000 207 radiologists have documented in a questionnaire the routine use of Xenetix in 61,754 patients that have received Xenetix for diagnostic procedures. On each questionnaire parameters regarding demographic data, safety, and diagnostic efficacy were assessed. The data were statistically evaluated and analysed. The examination allowed for a diagnosis in 99% of cases. Image quality was rated as "excellent" or "good" in 89.8% of cases. In obese patients there was a significantly higher percentage ( p<0.001) of poor image quality. In 0.1% poor contrast was noted. Of patients, 28.8% had at least one risk factor, and 3.1% had three or more. Adverse events were noted in 2.3% of the examinations, but nearly half of them (1.1%) presented with "feeling of warmth" as the only symptom. Of adverse events, 0.2% were non-transient, and 1 patient died. In 0.2% of patients the procedure was stopped due to adverse events. In 0.9% of patients the causal relationship with the contrast agent was rated as probable (probable+possible=1.1%). The percentage of adverse events (excluding warmth) was independent of iodine concentration and of dose, and was higher in young patients. Xenetix is an efficient contrast agent for radiological procedures and is associated with a low rate of adverse events.

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“…Previous studies using renal cortical slices have demonstrated that PAH accumulation was inhibited by many kinds of nephrotoxic agents, including antibiotics, 13,18 heavy metals, 18 and Pt-containing anticancer drugs. 5,19 Wasaki et al 20 studied the effects of nonionic CM on PAH accumulation in rat renal slices and reported that iobitridol, a newly developed nonionic CM, had a significantly smaller effect on PAH accumulation than iohexol. Those earlier experiments demonstrated that determinating the PAH accumulation in renal slices is a reliable method for evaluating the effects of nephrotoxic agents on the metabolic function of renal epithelial cells.…”

Section: Discussionmentioning

confidence: 99%

Inhibition of gluconeogenesis and p -aminohipuric acid accumulation in rat renal cortical slices by ionic and nonionic contrast media

Nakamura

Uozumi²,

Soejima³

et al. 2003

Clinical and Experimental Nephrology

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Comparative Toxic Effects of Iobitridol and Iohexol on the Kidney

Abstract: These findings suggest that iobitridol has significantly less toxic effects on the kidney compared with iohexol under the condition of our experiment.

Cited by 12 publications

References 27 publications

Intravenous Contrast Media in Uroradiology: Evaluation of Safety and Tolerability in Almost 50,000 Patients

Intravenous Contrast Media in Uroradiology: Evaluation of Safety and Tolerability in Almost 50,000 Patients

Results of the safety and efficacy of iobitridol in more than 61,000 patients

Inhibition of gluconeogenesis and p -aminohipuric acid accumulation in rat renal cortical slices by ionic and nonionic contrast media

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