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Related Experiment Videos

The OptiMARK clinical development program: summary of safety data.

Jeffrey J Brown1, Rita M Kristy, Gary R Stevens

  • 1Mallinckrodt Institute of Radiology, St. Louis, Missouri 63110, USA. brownj@mfr.wustl.edu

Journal of Magnetic Resonance Imaging : JMRI
|April 12, 2002
PubMed
Summary
This summary is machine-generated.

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OptiMARK, a contrast agent, demonstrated safety and good tolerability in clinical trials. Its adverse event profile was comparable to Magnevist, indicating its suitability for medical imaging.

Area of Science:

  • Radiology and Medical Imaging
  • Clinical Pharmacology
  • Pharmacovigilance

Background:

  • Clinical development programs are essential for evaluating the safety and efficacy of new medical agents.
  • Contrast agents play a crucial role in enhancing the visibility of internal body structures during medical imaging.
  • Understanding the safety profile of contrast agents is paramount for patient care and clinical decision-making.

Purpose of the Study:

  • To comprehensively document and analyze the safety data derived from the OptiMARK clinical development program.
  • To assess the tolerability and adverse event profile of OptiMARK in diverse patient populations and imaging applications.

Main Methods:

  • Conducted 18 clinical studies involving 1684 subjects who received 2038 injections of OptiMARK, Magnevist, or placebo.

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  • Administered varying doses (0.1–0.7 mmol/kg) to healthy volunteers and patients with hepatic, renal, or various pathologies.
  • Performed systematic safety assessments throughout Phase 1, 2, and 3 studies.

    • Main Results:

    • A total of 1293 adverse events were reported in 646 out of 1684 subjects.
    • OptiMARK injections were associated with adverse events in 31% of cases.
    • Adverse event rates for OptiMARK (31%) were lower than placebo (48%) and similar to Magnevist (35%).

    Conclusions:

    • OptiMARK was found to be safe and well-tolerated across the clinical development program.
    • The safety profile of OptiMARK closely resembles that of Magnevist.
    • OptiMARK is a viable and safe option for diagnostic medical imaging.