title: Safety of contrast-enhanced MR angiography employing gadobutrol 1.0 M as contrast material.
abstract: Our objectives were to evaluate the safety of intravenous 1.0-M gadobutrol injections in patients with an indication for contrast-enhanced magnetic resonance angiography (CE MRA) of supra-aortal, pelvic, or peripheral arteries by examining and assessing adverse events, laboratory values, vital signs and ECG findings for clinical significance. In 435 patients, recruited in three multicenter trials for safety evaluations of the new contrast agent 1.0-M gadobutrol, CE MRA was performed with 1.0- to 1.5-T scanners using three-dimensional gradient-echo sequences and phased-array coils. The study population comprised 312 men and 123 women with a mean age of 60.9 years. Two hundred seven patients had an indication for imaging of body arteries and 228 had an indication for imaging of peripheral arteries. Blood laboratory values and urinalysis results of 124 patients as well as heart rate, blood pressure, and 12-lead-electrocardiogram readings of 93 patients obtained during a follow-up period of up to 72 h after the injection of contrast media were available for safety analysis. Contrast media application was performed as intravenous bolus injection of 1.0-M gadobutrol in fixed doses according to the patients' body weight (b.w.) and indication for CE MRA and was followed by a 20- to 40-ml saline flush. Mean dose actually applied was 0.1 0.27 mmol/kg b.w. Flow rate ranged between 0.2 and 2.0 ml/s. Safety evaluations found a good tolerability with only 4.6% of at least "possibly related" adverse reactions and no clinically relevant changes in blood and urine samples including no transmetallation effect on serum zinc values. Analysis of renal tolerance showed no influence on renal function irrespective of preexisting renal impairment. The ECG analysis (rhythm analysis, pace-setting disturbances, conduction disturbances, and time interval measurements, including uncorrected and corrected QT) showed no clinically relevant effect of the injection of 1.0-M gadobutrol on the cardiac conduction system. Intravenous injection of 1.0-M gadobutrol at a dose of up to 0.1 0.27 mmol/kg b.w. in the indication CE MRA is safe and causes no clinically relevant changes in safety parameters such as heart rate, blood pressure, blood and urine laboratory values, and cardiac conduction system.
authors.affiliation: Department of Diagnostic and Interventional Radiology, Johann Wolfgang Goethe University, University Clinic Frankfurt/Main, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany. j.o.balzer@em.uni-frankfurt.de
authors.forename: Jörn O
authors.initials: JO
authors.lastname: Balzer
authors.forename: Christian
authors.initials: C
authors.lastname: Loewe
authors.forename: Kirsten
authors.initials: K
authors.lastname: Davis
authors.forename: Mathias
authors.initials: M
authors.lastname: Goyen
authors.forename: Tim
authors.initials: T
authors.lastname: Leiner
authors.forename: James F M
authors.initials: JF
authors.lastname: Meaney
authors.forename: Christiane
authors.initials: C
authors.lastname: Pöckler-Schöniger
authors.forename: Gernot
authors.initials: G
authors.lastname: Schulte-Altedorneburg
authors.forename: Bernd
authors.initials: B
authors.lastname: Tombach
authors.forename: Rolf
authors.initials: R
authors.lastname: Vosshenrich
authors.forename: Robin
authors.initials: R
authors.lastname: Wegener
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D003287:Contrast Media / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007275:Injections, Intravenous; D018810:Magnetic Resonance Angiography; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects*; D014652:Vascular Diseases / Q000175:diagnosis*; D015032:Zinc / Q000097:blood
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D003404:Creatinine; D015032:Zinc