Page last updated: 2024-12-08

optimark

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Cross-References

ID SourceID
PubMed CID23581832
MeSH IDM0291275

Synonyms (5)

Synonym
GADOVERSETAMIDE ,
[8,11-bis(carboxymethyl)-14-[2-[(2-methoxyethyl)amno]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)] gadolinium
optimark
131069-91-5
oxidanium;2-[bis[2-[carboxylatomethyl-[2-(2-methoxyethylamino)-2-oxoethyl]amino]ethyl]amino]acetate;gadolinium(3+)

Research Excerpts

Toxicity

OptiMARK was safe and well-tolerated with a safety profile similar to that of Magnevist. Despite a prolonged elimination half-life in subjects with renal impairment.

ExcerptReferenceRelevance
" Adverse events were recorded."( A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical
Bluemke, D; Brown, J; Desser, TS; Fultz, P; Ho, V; Kristy, RM; Nelson, R; Nghiem, HV; Pierro, JA; Reimer, P; Rubin, DL; Semelka, R; Stevens, WR, 1999
)
0.3
" OptiMARK is safe and well-tolerated following a single intravenous injection in subjects with either liver or CNS pathology despite a prolonged elimination half-life in subjects with renal impairment."( Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function.
Baker, JF; Barr, R; Barr, W; Barron, B; Free, R; Gazelle, GS; Lambrecht, LJ; Maravilla, KR; Pierro, JA; Seltzer, S; Stevens, GR; Swan, SK; Tucker, RM, 1999
)
0.3
"Of the 1684 subjects exposed to a study drug or placebo in the clinical development program, 646 subjects experienced 1293 adverse events."( The OptiMARK clinical development program: summary of safety data.
Brown, JJ; Kristy, RM; Pierro, JA; Stevens, GR, 2002
)
0.31
"OptiMARK was safe and well-tolerated with a safety profile similar to that of Magnevist."( The OptiMARK clinical development program: summary of safety data.
Brown, JJ; Kristy, RM; Pierro, JA; Stevens, GR, 2002
)
0.31
" The safety assessment was based on changes in physical examination, vital signs, electrocardiograms (ECGs), standard clinical laboratory tests, and adverse events (AEs) through a 24-hour postinjection period."( Safety assessment of gadoversetamide (OptiMARK) administered by power injector.
Abdou, N; Allen, JC; Hynes, MR; Napoli, AM; Wible, JH, 2004
)
0.32
" Safety of gadoversetamide was evaluated by physical examinations and monitoring of adverse events, laboratory values, vital signs, and electrocardiogram readings before and after drug administration."( The safety and efficacy of neuroimaging with gadoversetamide injection in pediatric patients.
Kearns, GL; Lowe, LH; Wible, JH, 2006
)
0.33
"No drug-related moderate or serious adverse events were observed in this study, according to site investigators."( The safety and efficacy of neuroimaging with gadoversetamide injection in pediatric patients.
Kearns, GL; Lowe, LH; Wible, JH, 2006
)
0.33
" Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration."( Safety of gadoversetamide in patients with acute and chronic myocardial infarction.
Biederman, R; Cheong, B; Flamm, SD; Fuisz, A; Grothues, F; Huber, S; Kevorkian, R; Kim, RJ; Kramer, C; Lombardi, M; Mahrholdt, H; Martin, E; Masoli, O; Muthupillai, R; Rochitte, CE; Schwaiger, CM; Shah, D; van Rossum, AC; Wible, JH; Woodard, P, 2008
)
0.35
" Any major adverse cardiac event (MACE) or other serious adverse events in the first 24 h after MRI were recorded."( Cardiac magnetic resonance imaging safety following percutaneous coronary intervention.
Curtis, JW; Lesniak, DC; Wible, JH; Woodard, PK, 2013
)
0.39
" In the 3 decades since initial approval, these have proven in general to be very safe for human administration."( Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommend
Runge, VM, 2017
)
0.46
"To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging."( Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients.
Bremerich, J; Francone, M; Grothoff, M; Gutberlet, M; Jacquier, A; Loewe, C; Lotz, J; Lücke, C; Lurz, P; May, MS; Schülke, C; Schuster, A; Uhlig, J; Vliegenthart, R; Zapf, A, 2019
)
0.51
"• Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0."( Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients.
Bremerich, J; Francone, M; Grothoff, M; Gutberlet, M; Jacquier, A; Loewe, C; Lotz, J; Lücke, C; Lurz, P; May, MS; Schülke, C; Schuster, A; Uhlig, J; Vliegenthart, R; Zapf, A, 2019
)
0.51

Pharmacokinetics

ExcerptReferenceRelevance
"The pharmacokinetic parameters, safety, and tolerability of OptiMARK (gadoversetamide injection), a gadolinium-based magnetic resonance imaging (MRI) contrast agent, were evaluated in 163 subjects with either central nervous system (CNS) or liver pathology with and without renal insufficiency, for which a contrast-enhanced MRI was indicated."( Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function.
Baker, JF; Barr, R; Barr, W; Barron, B; Free, R; Gazelle, GS; Lambrecht, LJ; Maravilla, KR; Pierro, JA; Seltzer, S; Stevens, GR; Swan, SK; Tucker, RM, 1999
)
0.3
" Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups: 2 years to <5 years and 5 years to <18 years of age."( Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (OptiMARK) in healthy pediatric subjects.
Baker, JF; Kratz, LC; Stevens, GR; Wible, JH, 2004
)
0.32
"05) age-related trends in the mean elimination half-life (t 1/2) of gadolinium with the older group having a slightly longer t 1/2 (1."( Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (OptiMARK) in healthy pediatric subjects.
Baker, JF; Kratz, LC; Stevens, GR; Wible, JH, 2004
)
0.32
"The pharmacokinetic behavior of gadoversetamide was not significantly altered by differences in age or sex in pediatric patients from 2 to 18 years of age."( Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients.
Kearns, GL; Lowe, LH; Napoli, AM; Tata, PN; Wible, JH, 2009
)
0.35

Dosage Studied

ExcerptRelevanceReference
" Dosed daily for 4 weeks, gadoversetamide injection (0."( Toxicological assessment of gadoversetamide injection (OptiMARK), a new contrast-enhancement agent for use in magnetic resonance imaging.
Adams, MD; Barco, SJ; Galen, KP; Hynes, MR; MacDonald, JR; Periasamy, MP; Troup, CM; Wible , JH; Wojdyla, JK, 2001
)
0.31
"To compare total left ventricular mass assessment using steady state free precession (SSFP) and inversion recovery fast gradient echo (IR GRE) imaging and further to assess the influence of contrast dosage on mass by IR GRE and its implications on relative infarct size assessment with both methods."( Comparison of SSFP and IR GRE techniques for measurement of total myocardial mass-influence of applied contrast dosage and implication for relative infarct size assessment.
Alpers, S; Bartels, D; Boenigk, H; Ghanem, A; Grothues, F; Klein, HU; Schwerdtfeger, A; Tempelmann, C, 2007
)
0.34
" Using a dosing regimen to simulate the exposure seen in patients with severe renal impairment, we investigated the effect of excess ligand on Gd-deposition and the depletion of endogenous ions."( Gadolinium-based contrast agents and their potential role in the pathogenesis of nephrogenic systemic fibrosis: the role of excess ligand.
Frenzel, T; Lengsfeld, P; Pietsch, H; Schirmer, H; Sieber, MA; Siegmund, F; Walter, J; Weinmann, HJ, 2008
)
0.35
" Growth curves supported the dose-response observations."( Effect of different classes of gadolinium-based contrast agents on control and nephrogenic systemic fibrosis-derived fibroblast proliferation.
Burden, AD; Edward, M; Jardine, AG; Newton, BB; Quinn, JA, 2010
)
0.36
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (74)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's6 (8.11)18.2507
2000's38 (51.35)29.6817
2010's28 (37.84)24.3611
2020's2 (2.70)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials12 (16.22%)5.53%
Reviews7 (9.46%)6.00%
Case Studies4 (5.41%)4.05%
Observational1 (1.35%)0.25%
Other50 (67.57%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]