Safety of Gadoterate Meglumine (Gd-DOTA) as a Contrast Agent for Magnetic Resonance Imaging

Ishiguchi, Tsuneo; Takahashi, Satoshi

doi:10.2165/11539140-000000000-00000

Cited by 43 publications

(46 citation statements)

References 20 publications

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“…Another analysis of 4,549 patients from 34 clinical trials reported a higher ADR incidence rate of 4.0 % [14], which can be attributed to the different methodology of data collection in randomized controlled clinical trials – including, for example, a longer follow-up duration (from 24 h to 7 days after gadobutrol administration) than in the current study, which followed routine clinical practice. Generally similar ADR rates have been reported for other GBCAs (Table 7) [13, 14, 18–22]. …”

Section: Discussionsupporting

confidence: 84%

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Prince

Lee

et al. 2016

Eur Radiol

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ObjectivesTo investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.MethodsGARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.ResultsMedian gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications.ConclusionsThe GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population.Key points• Gadobutrol at recommended dose shows low rates of adverse drug reactions • Gadobutrol demonstrates a uniform safety profile across diverse patient groups • Gadobutrol provides excellent contrast quality in routine practice

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Section: Discussionsupporting

confidence: 84%

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Prince

Lee

et al. 2016

Eur Radiol

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“…The mean (standard error of the mean) serum creatinine values (μmol/l) at baseline and 48 h post-procedure were 330.9 (42.2) and 306.2 (44.7), respectively, in the Gd-DOTA group and 329.7 (53.9) and 344.6 (64.9), respectively, in the control group. This absence of impact on renal function was also recently documented in a post-marketing study conducted in 3,444 Japanese patients [7]. Kidney function tests, performed as part of routine medical care in patients with impaired renal function, did not reveal any significant difference in terms of serum creatinine values (μmol/l; mean ± standard deviation) before (194.5 ± 194.5) and after (203.3 ± 194.5) Gd-DOTA administration.…”

Section: Discussionsupporting

confidence: 61%

“…The absence of CIN after Gd-DOTA administration was initially demonstrated in a small, randomised study conducted in CKD patients [6]. The absence of impact of Gd-DOTA on renal function was further documented in a large Japanese post-marketing study [7], and its good overall safety was confirmed in a surveillance study of 84,621 patients, including 764 patients with renal failure [8]. In a retrospective study conducted by Ergün et al [9] in 91 patients with stage 3 and 4 CKD [mean eGFR by the modified MDRD formula (Modification of Diet in Renal Disease): 33 ml/min/1.73 m 2 ] assessed by magnetic resonance imaging (MRI) with an intravenous dose of 0.2 mmol/kg of Gd-DOTA, gadopentetate dimeglumine, or gadodiamide, 11 patients (12.1 %) developed CIN.…”

Section: Introductionmentioning

confidence: 99%

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

et al. 2012

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ObjectiveTo prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.MethodsPatients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at −15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up.ResultsAmong the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Δ = −1.4 %, 95%CI = (−7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted.ConclusionMeglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD.Key points• Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI.• Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease.• Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients.• No case or sign of NSF was detected at 3-month follow-up.

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“…Doses of Gd-DOTA up to 0.325 mL/Kg and even uncommon greater than 0.2 mM/Kg were employed in patients [27].…”

Section: Discussionmentioning

confidence: 99%

N-Acetylcysteine Protects Rats with Chronic Renal Failure from Gadolinium-Chelate Nephrotoxicity

et al. 2012

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The aim of this study was to evaluate the effect of Gd-chelate on renal function, iron parameters and oxidative stress in rats with CRF and a possible protective effect of the antioxidant N-Acetylcysteine (NAC). Male Wistar rats were submitted to 5/6 nephrectomy (Nx) to induced CRF. An ionic - cyclic Gd (Gadoterate Meglumine) was administrated (1.5 mM/KgBW, intravenously) 21 days after Nx. Clearance studies were performed in 4 groups of anesthetized animals 48 hours following Gd- chelate administration: 1− Nx (n = 7); 2− Nx+NAC (n = 6); 3− Nx+Gd (n = 7); 4−Nx+NAC+Gd (4.8 g/L in drinking water), initiated 2 days before Gd-chelate administration and maintained during 4 days (n = 6). This group was compared with a control. We measured glomerular filtration rate, GFR (inulin clearance, ml/min/kg BW), proteinuria (mg/24 hs), serum iron (µg/dL); serum ferritin (ng/mL); transferrin saturation (%), TIBC (µg/dL) and TBARS (nmles/ml). Normal rats treated with the same dose of Gd-chelate presented similar GFR and proteinuria when compared with normal controls, indicating that at this dose Gd-chelate is not nephrotoxic to normal rats. Gd-chelate administration to Nx-rats results in a decrease of GFR and increased proteinuria associated with a decrease in TIBC, elevation of ferritin serum levels, transferrin oversaturation and plasmatic TBARS compared with Nx-rats. The prophylactic treatment with NAC reversed the decrease in GFR and the increase in proteinuria and all alterations in iron parameters and TBARS induced by Gd-chelate. NAC administration to Nx rat did not modify the inulin clearance and iron kinetics, indicating that the ameliorating effect of NAC was specific to Gd-chelate. These results suggest that NAC can prevent Gd-chelate nephrotoxicity in patients with chronic renal failure.

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Safety of Gadoterate Meglumine (Gd-DOTA) as a Contrast Agent for Magnetic Resonance Imaging

Cited by 43 publications

References 20 publications

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

N-Acetylcysteine Protects Rats with Chronic Renal Failure from Gadolinium-Chelate Nephrotoxicity

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