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Ioversol clinical safety summary
M Benamor1, E M Aten, K D McElvany
1Mallinckrodt Medical, Inc., St. Louis, Missouri 63134.
Investigative Radiology
|June 1, 1989
Summary
Ioversol, a new nonionic low-osmolality contrast medium, demonstrated excellent safety and diagnostic efficacy comparable to conventional agents. This new contrast agent was well-tolerated, with fewer adverse effects and no significant impact on renal function.
Area of Science:
- Radiology and Imaging
- Medical Contrast Agents
Background:
- Nonionic low-osmolality contrast media are increasingly used in medical imaging.
- Evaluating new contrast agents for safety and efficacy is crucial for clinical practice.
Purpose of the Study:
- To assess the safety and diagnostic efficacy of ioversol, a novel nonionic low-osmolality contrast medium.
- To compare ioversol's performance against conventional ionic and other nonionic contrast agents.
Main Methods:
- Evaluation of double-blind comparative and open-label clinical trials.
- Inclusion of 1,186 patients receiving ioversol at various iodine concentrations (32%, 24%, 16%).
- Monitoring of patient tolerance, adverse effects, diagnostic quality, and renal function up to 96 hours.
Main Results:
- Ioversol was well tolerated by all patients, exhibiting fewer adverse effects than conventional ionic agents.
- Diagnostic efficacy of ioversol was comparable to conventional and other nonionic agents.
- No clinically or statistically significant changes in renal function were observed.
Conclusions:
- Ioversol is a safe and effective nonionic low-osmolality contrast medium.
- Its improved patient tolerance may enhance radiograph quality.
- Ioversol presents a viable alternative for diagnostic imaging procedures with a favorable safety profile.