RATIONALE AND OBJECTIVES. TO review the safety and efficacy profiles of iom
eprol by examining the most indicative comparative clinical studies of iome
prol with widely used low-osmolar ionic or nonionic contrast agents, and to
illustrate the recent development in iomeprol liposomal formulations for l
iver imaging and intravascular enhancement.
METHODS. Randomized, double-blind, comparative studies were performed of io
meprol versus iopamidol, iopromide, ioxaglate, iopentol, iodixanol, ioverso
l, and iohexol, In all studies, safety controls included pre- and postadmin
istration physical examinations, monitoring of vital signs, electrocardiogr
aphy, clinical laboratory investigations, and 24- or 72-hour postadministra
tion monitoring of patients for adverse events, Technically adequate images
were rated for diagnostic efficacy by masked assessors.
RESULTS. Iomeprol showed similar safety and diagnostic efficacy compared wi
th the nonionic monomers iopamidol, iohexol, and ioversol, and no statistic
ally significant differences were observed. No differences in diagnostic ef
ficacy between iomeprol and iopromide were observed, but in one study on 12
00 patients, the incidence of adverse events and adverse reactions was sign
ificantly higher with iopromide than with iomeprol, Iomeprol caused signifi
cantly less heat/pain than iopentol in one study; it showed similar safety
and tolerability to the nonionic dimer iodixanol, the two agents causing no
or modest, superimposable pain and heat sensation at injection and showing
similar renal tolerability after intra-arterial injection. A comparison of
iomeprol versus ionic dimer ioxaglate in 2000 patients undergoing percutan
eous coronary interventions showed that the incidence of thrombus-related e
vents was similar with the two agents, but ioxaglate caused a significantly
higher incidence of allergy-like reactions. First results with iomeprol-co
ntaining liposomal formulations show that these agents may facilitate the C
T assessment of intrahepatic malignancies and CT angiography procedures.
CONCLUSIONS. The overall results of numerous randomized, double-blind, comp
arative clinical studies in a variety of indications show that the diagnost
ic efficacy of iomeprol solutions does not differ significantly from that o
f the low-osmolar contrast media available on the marketplace when similar
iodine strengths are used, although iomeprol may have better tolerability a
nd safety than the ionic dimer and some of the nonionic monomers in selecti
ve applications, First results obtained with iomeprol-containing liposomal
formulations are promising and may foster additional clinical testing.