Safety characteristics of gadobenate dimeglumine: clinical experience from intra- and interindividual comparison studies with gadopentetate dimeglumine.
OBJECTIVE
To evaluate the safety and tolerability of gadobenate dimeglumine (Gd-BOPTA) relative to that of gadopentetate dimeglumine (Gd-DTPA) in patients and volunteers undergoing MRI for various clinical conditions.


METHODS
A total of 924 subjects were enrolled in 10 clinical trials in which Gd-BOPTA was compared with Gd-DTPA. Of these subjects, 893 were patients with known or suspected disease and 31 were healthy adult volunteers. Of the 893 patients, 174 were pediatric subjects (aged two days to 17 years) referred for MRI of the brain or spine. Safety evaluations included monitoring vital signs, laboratory values, and adverse events (AE).


RESULTS
The rate of AE in adults was similar between the two agents (Gd-BOPTA: 51/561, 9.1%; Gd-DTPA: 33/472, 7.0%; P = 0.22). In parallel-group studies in which subjects were randomized to either agent, the rate of AE was 10.9% for Gd-BOPTA and 7.9% for Gd-DTPA (P = 0.21). In the subset of subjects receiving both agents in intraindividual crossover trials, the rate of AE was 8.0% for Gd-BOPTA and 8.5% for Gd-DTPA (P = 0.84). Results of other safety assessments (laboratory tests, vital signs) were similar for the two agents.


CONCLUSIONS
The safety profile of Gd-BOPTA is similar to Gd-DTPA in patients and volunteers. Both compounds are equally well-tolerated in patients with various disease states undergoing MRI.
Shellock
Frank G
FG
University of Southern California and Institute for Magnetic Resonance Safety, Education and Research, Los Angeles, California 90045, USA. frank.shellock@gte.net
Parker
John R
JR
Pirovano
Gianpaolo
G
Shen
Ningyan
N
Venetianer
Carol
C
Kirchin
Miles A
MA
Spinazzi
Alberto
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003287:Contrast Media / Q000009:adverse effects; D005334:Fever / Q000209:etiology*; D019786:Gadolinium DTPA / Q000009:adverse effects*; D006470:Hemorrhage / Q000209:etiology*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D008875:Middle Aged; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014839:Vomiting / Q000209:etiology*
D003287:Contrast Media; D019786:Gadolinium DTPA