Breakthrough Adverse Reactions to Low-Osmolar Contrast Media After  Steroid Premedication

Freed, Kelly S.; Leder, Richard A.; Alexander, Cindy; DeLong, David M.; Kliewer, Mark A.

doi:10.2214/ajr.176.6.1761389

Cited by 131 publications

(69 citation statements)

References 22 publications

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“…In our analyses, the benefits of premedication were most pronounced in terms of a reduction in the incidence of sneezing, pruritus, urticaria and rash. However, "breakthrough" ADRs still occurred in some patients, and this finding is consistent with previous studies [21]. While a controversy remains regarding the use of premedication for patients at high risk of an ADR [1] [9], the present study appears to support the recommendation to use appropriate premedication in Chinese patients at risk of such reactions.…”

Section: Discussionsupporting

confidence: 91%

Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Zhang¹,

Liang²,

Li³

et al. 2017

OJRad

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Background: Iopromide (Ultravist ® ) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 atrisk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician's evaluation of image parameters, contrast quality was considered to be "good" (64.7%) or "excellent" (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient populaHow to cite this paper: Zhang, S.X., Liang, C.G., Li, Z.P. and Wang, J. 64tion, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.

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Section: Discussionsupporting

confidence: 91%

Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Zhang¹,

Liang²,

Li³

et al. 2017

OJRad

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“…Although corticosteroids do prevent severe allergiclike reactions to low or iso-osmolality iodinated contrast material, the effect has been shown to be incomplete (7,14,15), breakthrough reactions can occur (14,15), and the NNT is large (7). Therefore, we are interested to know whether the costs and indirect harm associated with corticosteroid prophylaxis are greater than the potential benefits.…”

Section: Study Cohort: Population Detailsmentioning

confidence: 99%

Indirect Cost and Harm Attributable to Oral 13-Hour Inpatient Corticosteroid Prophylaxis before Contrast-enhanced CT

Davenport¹,

Mervak²,

Ellis³

et al. 2016

Radiology

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Purpose:To estimate the effect of an oral 13-hour inpatient corticosteroid premedication regimen on length of stay, hospital cost, and hospital-acquired infections (HAIs) by using a combination of real and hypothetical study populations. Materials and Methods:Institutional review board approval was obtained and informed consent waived for this HIPAA-compliant retrospective study. Inpatients who received an oral 13-hour corticosteroid premedication regimen before contrast material-enhanced CT (n = 1424) from 2008 to 2013 were matched by age, sex, and year when CT was performed to a control cohort (n = 1425) of patients who underwent contrast-enhanced CT without premedication and who had similar rates of 13 comorbid diseases. Length of stay in the hospital and time from admission to CT were compared by using the Mann-Whitney U test. Rates of prospectively reported HAIs were compared by using x 2 tests. The indirect cost and risk of HAI with premedication were estimated by using published data. Results:Premedicated inpatients had a significantly longer median length of stay (+25 hours; 158 vs 133 hours, P , .001), a significantly longer median time to CT (+25 hours, 42 vs 17 hours, respectively; P , .001), and a significantly greater risk of HAI (5.1% [72 of 1424] vs 3.1% [44 of 1424], respectively; P = .008) compared with nonpremedicated control subjects. On the basis of these data and existing references, the prolonged length of stay was estimated to result in 0.04 HAI-related deaths and a cost of $159 131 (in U.S. dollars) for each prevented reaction of any severity and 32 HAI-related deaths and a cost of $131 211 400 for each prevented reaction-related death. Conclusion:Oral 13-hour inpatient corticosteroid prophylaxis is associated with substantial cost relative to its modest benefit, and may cause more indirect harm than the direct harm that it prevents.q RSNA, 2015

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“…Freed et al [25] reported a case of a severe anaphylactoidlike reaction associated with an iodinated contrast media retrograde study into a bowel segment that was part of a urinary diversion.…”

Section: Urinary System Reactionsmentioning

confidence: 99%

Anaphylactoid Reactions to the Nonvascular Administration of Water-Soluble Iodinated Contrast Media

Davis

2015

American Journal of Roentgenology

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Breakthrough Adverse Reactions to Low-Osmolar Contrast Media After Steroid Premedication

Cited by 131 publications

References 22 publications

Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Indirect Cost and Harm Attributable to Oral 13-Hour Inpatient Corticosteroid Prophylaxis before Contrast-enhanced CT

Anaphylactoid Reactions to the Nonvascular Administration of Water-Soluble Iodinated Contrast Media

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Breakthrough Adverse Reactions to Low-Osmolar Contrast Media After Steroid Premedication

Cited by 131 publications

References 22 publications

Safety and Diagnostic Image Quality of Ultravist&lt;sup&gt;&#174;&lt;/sup&gt; in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Safety and Diagnostic Image Quality of Ultravist&lt;sup&gt;&#174;&lt;/sup&gt; in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Indirect Cost and Harm Attributable to Oral 13-Hour Inpatient Corticosteroid Prophylaxis before Contrast-enhanced CT

Anaphylactoid Reactions to the Nonvascular Administration of Water-Soluble Iodinated Contrast Media

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Product

Resources

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Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Safety and Diagnostic Image Quality of Ultravist<sup>®</sup> in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance