Cardiovascular safety of gadoterate meglumine (Gd-DOTA).
OBJECTIVE
Gadolinium complexes are not considered to be a drug class at high risk for prolonging cardiac repolarization, which can lead to potentially life-threatening arrhythmias such as torsade de pointes. However, only limited robust data are available on these compounds despite their extensive use as contrast enhancers in magnetic resonance imaging. We present an overview of recent cardiovascular safety data obtained on gadoterate meglumine (Gd-DOTA).


METHODS
Cardiovascular safety was evaluated by "state-of-the-art" nonclinical ex vitro (dog Purkinje fibers) and in vivo studies in both normal (dogs) and sensitized animal models (rabbits) and in patients with various diseases in a specific clinical trial.


RESULTS
In all of these studies, Gd-DOTA did not show any direct deleterious effect on cardiac electrophysiology and especially on ventricular repolarization.


CONCLUSIONS
These results confirmed the good safety profile of Gd-DOTA derived from postmarketing evaluations. Nonspecific gadolinium complexes used for magnetic resonance contrast enhancement do not constitute a class-at-risk for drug-related arrhythmias.
Bourrinet
Philippe
P
Guerbet, Roissy CDG, France. philippe.bourrinet@guerbet-group.com
Martel
Eric
E
El Amrani
Abdel I
AI
Champeroux
Pascal
P
Richard
Serge
S
Fauchou
Nicolas
N
Le Coz
Franck
F
Drici
Milo
M
Bonnemain
Bruno
B
Gaillard
Sophie
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001794:Blood Pressure / Q000187:drug effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology*; D003287:Contrast Media / Q000009:adverse effects*; D004285:Dogs; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006321:Heart / Q000187:drug effects*; D006339:Heart Rate / Q000187:drug effects*; D006571:Heterocyclic Compounds / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects*; D018570:Risk Assessment
D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C050823:gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate