Cardiac Electrophysiologic Monitoring after Injection of Gadobenate Dimeglumine versus Placebo in Healthy Volunteers and Patients with Cardiovascular Disease

Pirovano, Gianpaolo; Goodman, Daniel B.; Halemane, Usha; Venetianer, Carole; Kirchin, Miles A.; Spinazzi, Alberto

doi:10.1148/radiol.2332031802

Cited by 7 publications

(4 citation statements)

References 15 publications

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“…Moreover, cardiodepressive and hypotensive effects caused by gadopentetate dimeglumine are dose-dependent [ 24 , 26 ]. This data was confirmed by Pirovano et al who showed that the injection of 0.2 mmol/kg gadobenate dimeglumine had no detrimental effect on cardiac electrophysiology, or other safety parameters, in healthy volunteers or patients with coronary artery disease [ 27 ].…”

Section: Discussionsupporting

confidence: 56%

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Granata

Cascella

Fusco

et al. 2016

BioMed Research International

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Background and Purpose. Contrast media (CM) for magnetic resonance imaging (MRI) may determine the development of acute adverse reactions. Objective was to retrospectively assess the frequency and severity of adverse reactions associated with gadolinium-based contrast agents (GBCAs) injection in patients who underwent MRI. Material and Methods. At our center 10608 MRI examinations with CM were performed using five different GBCAs: Gd-BOPTA (MultiHance), Gd-DTPA (Magnevist), Gd-EOBDTPA (Primovist), Gd-DOTA (Dotarem), and Gd-BTDO3A (Gadovist). Results. 32 acute adverse reactions occurred, accounting for 0.3% of all administration. Twelve reactions were associated with Gd-DOTA injection (0.11%), 9 with Gd-BOPTA injection (0.08%), 6 with Gd-BTDO3A (0.056%), 3 with Gd-EOB-DTPA (0.028%), and 2 with Gd-DTPA (0.018%). Twenty-four reactions (75.0%) were mild, four (12.5%) moderate, and four (12.5%) severe. The most severe reactions were seen associated with use of Gd-BOPTA, with 3 severe reactions in 32 total reactions. Conclusion. Acute adverse reactions are generally rare with the overall adverse reaction rate of 0.3%. The most common adverse reactions were not severe, consisting in skin rash and hives.

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Section: Discussionsupporting

confidence: 56%

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Granata

Cascella

Fusco

et al. 2016

BioMed Research International

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“…To date, more than 4000 subjects have been administered Gd‐BOPTA in clinical trials, while a further 1.5 million patients have been administered the agent in routine clinical practice (Bracco Diagnostics, Inc., data on file). Reports published to date on the safety of Gd‐BOPTA in clinical trials and on the basis of postmarketing surveillance have shown that this agent is well‐tolerated by patients and that the incidence and type of reported AE are similar to those reported for other approved gadolinium agents (22–24). Literature comparisons of the safety profiles of Gd‐BOPTA and other FDA‐approved gadolinium agents have confirmed that the differences between these agents are negligible, particularly with regard to the most frequently reported AE (Table 5) (18, 24–28).…”

Section: Discussionmentioning

confidence: 71%

Safety characteristics of gadobenate dimeglumine: Clinical experience from intra‐ and interindividual comparison studies with gadopentetate dimeglumine

Shellock

Parker

Pirovano

et al. 2006

Magnetic Resonance Imaging

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“…A randomized, double‐blind, placebo‐controlled, crossover clinical trial in patients requiring contrast‐enhanced MRI did not show any significant QTc prolongation with gadoterate meglumine 22 . In a 2‐way crossover study comparing gadobenate at a dose of 0.2 mmol kg −1 to placebo an increase of 3.1 ms in ΔΔQTcB was observed with no difference between healthy volunteers and patients with coronary artery disease 23 . It is interesting to note that both gadobutrol and gadobenate have a higher osmolarity at marketed concentrations (1603 and 1970 mOsm l −1 , respectively) than gadopiclenol (843 mOsm l −1 ) 13 .…”

Section: Discussionmentioning

confidence: 90%

Randomized study of the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval in healthy subjects

Funck‐Brentano

Felices²,

Fur

et al. 2020

Brit J Clinical Pharma

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We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product. Methods: This was a single centre, randomized, double-blind, placebo-and positivecontrolled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg −1 , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg −1 , placebo and a single oral dose of 400 mg moxifloxacin. Results: The largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg −1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg −1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg −1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported. Conclusion: This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia.

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Cardiac Electrophysiologic Monitoring after Injection of Gadobenate Dimeglumine versus Placebo in Healthy Volunteers and Patients with Cardiovascular Disease

Abstract: Injection of 0.2 mmol/kg gadobenate dimeglumine has no detrimental effect on cardiac electrophysiology or other safety parameters in healthy volunteers or patients with CAD.

Cited by 7 publications

References 15 publications

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

Safety characteristics of gadobenate dimeglumine: Clinical experience from intra‐ and interindividual comparison studies with gadopentetate dimeglumine

Randomized study of the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval in healthy subjects

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