Magnetic resonance imaging in patients with central nervous system pathology: a comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA).
OBJECTIVE
The objective of the two pivotal phase 3 studies was to evaluate the safety and efficacy of OptiMARK (Gd-DTPA-bis(methoxyethylamide) [Gd-DTPA-BMEA]) compared with Magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system.


METHODS
Two multicenter, randomized, double-blind, parallel group studies were conducted in 395 patients with known or suspected central nervous system pathology. Subjects were randomized to receive a single 0.1 mmol/kg intravenous injection of either Gd-DTPA-BMEA or Gd-DTPA. The safety of Gd-DTPA-BMEA and Gd-DTPA was monitored for up to 72 hours after study drug administration. Precontrast and postcontrast administration magnetic resonance scans were acquired using identical imaging planes and techniques.


RESULTS
No deaths or unexpected adverse events were reported in either group. A comparison of adverse events by intensity and relation demonstrated no statistically significant differences between the two groups. Gd-DTPA-BMEA and Gd-DTPA were equivalent with respect to confidence in diagnosis, conspicuity, and border delineation.


CONCLUSIONS
Gd-DTPA-BMEA and Gd-DTPA demonstrated comparable efficacy profiles, and the safety profiles were considered similar.
Grossman
R I
RI
University of Pennsylvania Medical Center, Philadelphia, USA.
Rubin
D L
DL
Hunter
G
G
Haughton
V M
VM
Lee
D
D
Sze
G
G
Kuhn
M J
MJ
Maravilla
K
K
Tu
R
R
Heindel
W
W
Wippold
F J
FJ
Leeds
N
N
Zelch
J
J
Jinkins
J R
JR
Grodd
W
W
Truwit
C
C
Kanal
E
E
Provenzale
J M
JM
Ramsey
R
R
Simon
J
J
Brunberg
J A
JA
Stevens
G R
GR
Kristy
R M
RM
D000328:Adult; D000368:Aged; D001921:Brain / Q000473:pathology; D002493:Central Nervous System Diseases / Q000473:pathology*; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005682:Gadolinium; D019786:Gadolinium DTPA / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects; D013116:Spinal Cord / Q000473:pathology
D003287:Contrast Media; D009942:Organometallic Compounds; D005682:Gadolinium; D019786:Gadolinium DTPA; C112666:gadoversetamide