An observational study to evaluate the efficiency and safety of ioversol pre-filled syringes compared with ioversol bottles in contrast-enhanced examinations

Vogl, T. J.; Weßling, Johannes; Buerke, Boris

doi:10.1258/ar.2012.120303

Cited by 3 publications

(6 citation statements)

References 18 publications

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“…Among the selected studies, 26 [ 17 , 18 , 20 – 38 , 40 , 42 – 45 ] documented the incidence of all ADRs or specifically HSRs (56,502 patients and 1,613,481 doses) and 5 studies [ 16 , 19 , 39 , 46 , 47 ] reported the incidence of PC-AKI (1335 patients). Contrast-enhanced CT was the main indication for which ioversol was used, followed by venography and urography.…”

Section: Resultsmentioning

confidence: 99%

“…The overall incidence of ADRs in adults was reported in 15 studies [ 17 , 20 – 26 , 28 , 29 , 32 , 33 , 35 , 42 , 43 ] with a median of 0.23%. In two studies where heat sensation was assessed in a specific questionnaire, a higher incidence of ADRs was reported (42–63%) [ 31 , 34 ].…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Three other studies reported incidences between 0.13 and 0.23% [ 17 , 42 , 43 ]. Vogl et al [ 42 ] reported ADRs in 0.28% of 10,836 patients, mainly urticaria (0.12%), nausea (0.10%), and erythema (0.06%). Four serious ADRs (0.037%) were reported, including 3 anaphylactoid reactions requiring hospitalization (0.028%).…”

Section: Resultsmentioning

confidence: 99%

“…Anaphylactoid reaction incidence in patients exposed to ioversol was reported in two studies ranging from 0.18% [ 42 ] to 2.5% [ 45 ]. Federle et al [ 45 ] reported more than a threefold higher incidence of anaphylactoid reactions with iothalamate compared to ioversol at both slow (8.3% vs. 2.0%, respectively) and fast (9.1% vs. 2.5%, respectively) injection rates.…”

Section: Resultsmentioning

confidence: 99%

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A systematic review of the incidence of hypersensitivity reactions and post-contrast acute kidney injury after ioversol in more than 57,000 patients: part 1—intravenous administration

et al. 2022

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Objectives To evaluate the incidence of adverse drug reactions (ADRs), including hypersensitivity reactions (HSRs) and post-contrast acute kidney injury (PC-AKI), after intravenous (IV) administration of ioversol. Materials and methods A systematic literature search (1980–2021) of studies documenting IV use of ioversol and presence or absence of ADRs, HSRs, or PC-AKI was performed. Key information including patients’ characteristics, indication and dose of ioversol, safety outcome incidence, intensity and seriousness were extracted. Results Thirty-one studies (> 57,000 patients) were selected, including 4 pediatric studies. The incidence of ADRs in adults was reported in 12 studies from ioversol clinical development with a median (range) of 1.65% (0–33.3%), and 3 other studies with an incidence between 0.13 and 0.28%. The incidence of HSRs (reported in 2 studies) ranged from 0.20 to 0.66%, and acute events (4 studies) from 0.23 to 1.80%. Severe reactions were rare with a median (range) of 0 (0–4%), and none were reported among pediatric patients. The incidence of ADRs and HSRs with ioversol, especially those of severe intensity, was among the lowest in studies comparing different iodinated contrast media (ICM) of the same class. PC-AKI incidence was variable (1–42% in 5 studies); however, ioversol exposure per se did not increase the incidence. Conclusions When administered by the IV route, ioversol has a good safety profile comparable to that of other ICM within the same class, with a low incidence of severe/serious ADRs overall, and particularly HSRs. PC-AKI incidence does not seem to be increased compared to patients who did not receive ioversol. Further well-designed studies are warranted to confirm these results. Key Points • Ioversol has a good safety profile in adult and pediatric patients when IV administered. • ADR and HSR incidence with ioversol, especially those of severe intensity, was among the lowest compared to other ICM. • IV administration of ioversol per se did not increase PC-AKI incidence.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

A systematic review of the incidence of hypersensitivity reactions and post-contrast acute kidney injury after ioversol in more than 57,000 patients: part 1—intravenous administration

et al. 2022

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Acute Adverse Reactions to Nonionic Iodinated Contrast Media

et al. 2019

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Objectives We aimed to meta-analytically compare the incidence of acute adverse reactions (AARs) to nonionic iodinated contrast media (ICM) according to the type of ICM in patients who underwent radiologic examinations with administration of ICM via intravascular route. Materials and Methods A systematic literature search identified studies evaluating the incidence of AARs to 7 nonionic ICM (iobitridol, iohexol, iomeprol, iopamidol, iopromide, ioversol, and iodixanol) with extractable outcomes. These outcomes were pooled using a random-effects model, and the effect of ICM type on the incidence of overall and severe AARs was evaluated using meta-regression analysis. Results Thirty studies with 1,360,488 exposures to ICM were included. The pooled incidences of overall and severe AARs to nonionic ICM were 1.03% (95% confidence interval [CI], 0.81%–1.30%; I 2 = 0.99) and 0.0141% (95% CI, 0.0108%–0.0183%; I 2 = 0.56), respectively. Iomeprol had the highest overall AAR incidence (1.74%; 95% CI, 0.79%–3.76%; I 2 = 0.99), followed by iohexol (1.21%; 95% CI, 0.67%–2.17%; I 2 = 0.99), iopamidol (1.10%; 95% CI, 0.60%–2.03%; I 2 = 0.99), ioversol (0.88%; 95% CI, 0.43%–1.83%; I 2 = 0.96), iodixanol (0.85%; 95% CI, 0.36%–1.95%; I 2 = 0.99), iopromide (0.82%; 95% CI, 0.43%–1.55%; I 2 = 0.99), and iobitridol (0.77%; 95% CI, 0.36%–1.62%; I 2 = 0.99). Multivariable meta-regression analysis revealed that study design (P = 0.0014) and premedication (P = 0.0230) were statistically significant determinants affecting the incidence of overall AARs. Iodinated contrast media type did not affect the incidence of overall and severe AARs (P = 0.1453 and 0.4265, each). Conclusions The varying pooled incidences of overall and severe AARs to specific types of nonionic ICM do not remain as significant after adjusting confounders. Our results may support nonrestriction of certain types of nonionic ICM in the context of AAR avoidance.

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Safety Analysis of Iobitridol as a Nonionic Contrast Medium

et al. 2020

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Objectives Our study sought to reevaluate the safety and diagnostic efficacy of iobitridol as a nonionic contrast medium after almost 20 years of use. Materials and methods This noninterventional postmarketing surveillance noncontrolled, multicenter (168 centers in Germany) study enrolled 94,960 patients receiving intravenous or intra-arterial iobitridol. The majority of the adjusted population (n = 92,550, 98.2%) underwent either computed tomography examination (n = 46,502, 49.3%) or intravenous urography (n = 46,048, 48.8%). A standardized questionnaire was used to ascertain patient's information, known risk factors, renal function status, premedication, type of examination, injection of contrast agent, imaging quality, diagnostic value, and safety. Results A total of 469 patients (0.49%) experienced an adverse event (AE), and 24 patients (0.025%) reported a serious AE (SAE). All patients recovered and no fatal event occurred. The prevalence of AE was significantly higher in patients with at least one risk factor, with premedication, with a history of AE, in female and patients younger than 60 years old (P < 0.05). Presence of at least one risk factor is the only predictive factor for the prevalence of SAE (P = 0.042). In patients with a history of AE, premedication did not significantly lower the AE rate (P = 0.737). No statistically significant difference in the prevalence of AE between the different combination of cortisone and/or antihistamines as pretreatment was found. Conclusions Iobitridol is a safe contrast medium with a high tolerability and efficacy. Presence of risk factors such as cardiovascular diseases, allergies, or asthma was the only significant predictive factor for an AE and an SAE. Premedication did not significantly lower the occurrence of an AE and an SAE.

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An observational study to evaluate the efficiency and safety of ioversol pre-filled syringes compared with ioversol bottles in contrast-enhanced examinations

Abstract: Administration of ioversol for contrast-enhanced CT examinations is associated with a low incidence of AEs and is generally safe and well tolerated. Ioversol pre-filled syringes were associated with lower residual volumes and less potential re-use compared with bottles.

Cited by 3 publications

References 18 publications

A systematic review of the incidence of hypersensitivity reactions and post-contrast acute kidney injury after ioversol in more than 57,000 patients: part 1—intravenous administration

A systematic review of the incidence of hypersensitivity reactions and post-contrast acute kidney injury after ioversol in more than 57,000 patients: part 1—intravenous administration

Acute Adverse Reactions to Nonionic Iodinated Contrast Media

Safety Analysis of Iobitridol as a Nonionic Contrast Medium

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