Safety assessment of gadoversetamide (OptiMARK) administered by power injector.
ABSTRACT To evaluate the safety of OptiMARK (gadoversetamide injection) administered via power injector.
The study population included 144 healthy volunteers aged 18 years or older randomly assigned to one of seven treatment groups (N = 20/group). 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.
OptiMARK caused no serious AEs or unexpected changes in physical examinations or laboratory parameters. The changes observed in vital signs and ECG intervals did not vary with changes in injection rate and were not significantly (P < 0.05) different from those elicited by saline administration at the same rates.
This study demonstrated the safety of OptiMARK when administered via a power injector at rates of 2, 4, and 6 mL/second.
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ABSTRACT: The purpose of this study was to evaluate the safety and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in hepatic MRI of patients with suspected liver pathology. A Phase III, multicenter, randomized, double-blind, parallel group study was performed in adults with suspected liver pathology. All patients underwent contrast-enhanced computed tomography within 3 weeks prior to magnetic resonance scanning. Ninety-nine patients received OptiMARK, and 94 patients received Magnevist at a dose of 0.1 mmol/kg. Precontrast T1- and T2-weighted spin-echo imaging and T1-weighted gradient-echo imaging were performed, followed by T1-weighted gradient-echo imaging at 15-20 seconds, 1 minute, and 5 minutes after intravenous contrast injection. Three primary efficacy endpoints (confidence in lesion diagnosis, level of conspicuity, and lesion border delineation) were evaluated on the precontrast image set and compared with the pre plus postcontrast image set. Vital signs, physical examination, electrocardiograms (ECGs), and laboratory parameters (chemistry, hematology, and urinalysis) were measured at various time points. Adverse events were recorded. The study design and statistical analyses were chosen to demonstrate presumed equivalence of OptiMARK and Magnevist. There were no statistically significant differences in efficacy between OptiMARK and Magnevist as assessed by either blinded readers or the on-site principal investigators. No serious or unexpected adverse events were noted. Of the 193 patients receiving contrast media, 82 experienced a total of 154 adverse events. Thirty-three (21.4%) of these 154 adverse events were felt by the on-site investigators to be probably related to either study agent: 15 events in 9 patients in the OptiMARK group, and 18 events in 13 patients in the Magnevist group. Headache was the most common adverse event, occurring in 10.1% of the OptiMARK patients and 12.8% of the Magnevist patients. No clinically relevant trends were observed in any laboratory parameter or ECG findings in either treatment group. The results demonstrate the safety, efficacy, and equivalence of OptiMARK and Magnevist at a dose of 0.1 mmol/kg in hepatic magnetic resonance imaging of patients with suspected liver pathology.Journal of Magnetic Resonance Imaging 03/1999; 9(2):240-50. · 2.57 Impact Factor
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ABSTRACT: 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. A multicenter, double-blind, randomized, placebo-controlled, parallel-group design was used in which subjects received 0.1, 0.3, or 0.5 mmol/kg of OptiMARK or placebo intravenously. Samples were analyzed for total gadolinium by inductively coupled plasma/mass spectrometry. Gadolinium pharmacokinetics were affected by renal impairment: area under the curve, half-life, and steady-state distribution volume significantly increased with declining renal function, while total body clearance decreased. In subjects with normal renal function, neither age, gender, nor liver versus CNS pathology altered gadolinium pharmacokinetics. No clinically significant changes from baseline were noted in vital signs, laboratory measures, electrocardiograms, or physical examinations. 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.Journal of Magnetic Resonance Imaging 03/1999; 9(2):317-21. · 2.57 Impact Factor
- American Journal of Roentgenology 12/1995; 165(5):1290-2. · 2.90 Impact Factor