Introduction
OMNIPAQUE, a nonionic, water-soluble x-ray contrast medium containing iohexol, is widely used in various medical imaging procedures. This article focuses on OMNIPAQUE 140, one of the concentrations of this drug, and delves into its clinical trials, market analysis, and future projections.
Clinical Trials Overview
Indications and Usage
OMNIPAQUE 140 is indicated for several medical imaging procedures, including intravascular, oral, rectal, intraarticular, and body cavity administration. Here are some key indications:
- Intrathecal Administration: Although OMNIPAQUE 140 is not indicated for intrathecal use, other concentrations like OMNIPAQUE 180, 240, and 300 are used for myelography and CT scans in adults and children[5].
- Intra-Arterial Digital Subtraction Angiography: OMNIPAQUE 140 is used for imaging various arteries, including the aorta, carotid, femoral, and renal arteries[5].
Safety and Efficacy
Clinical trials have demonstrated the safety and efficacy of OMNIPAQUE in various concentrations. Here are some key findings:
- Adverse Reactions: Clinical studies involving 1531 patients reported adverse reactions such as hypersensitivity reactions, contrast-induced acute kidney injury, and cardiovascular reactions. However, these reactions were generally mild and transient[4].
- Comparative Studies: For oral administration, OMNIPAQUE 350 was compared to gastrografin 370 in adults, showing comparable or significantly better diagnostic quality images[1].
Specific Trials for OMNIPAQUE 140
While specific trials for OMNIPAQUE 140 are not extensively detailed, the drug's safety and efficacy are inferred from studies on other concentrations of OMNIPAQUE. For instance:
- Intra-Arterial Administration: Studies on OMNIPAQUE 140 for intra-arterial digital subtraction angiography have shown it to be safe and effective, with appropriate dosages and injection rates outlined for different arterial regions[5].
Market Analysis
Market Presence
OMNIPAQUE, including the 140 mg iodine/mL concentration, is a well-established product in the medical imaging market. It is widely used across various medical specialties, including radiology, cardiology, and gastroenterology.
Competitors
The market for x-ray contrast media is competitive, with several other products available, such as barium sulfate and other iohexol-based contrast agents. However, OMNIPAQUE's broad range of indications and its nonionic, water-soluble nature give it a competitive edge.
Market Trends
The demand for x-ray contrast media is driven by the increasing need for diagnostic imaging procedures. Advances in medical technology, an aging population, and the rising incidence of chronic diseases are all contributing factors.
Projections
Market Growth
The global market for x-ray contrast media is expected to grow, driven by the increasing demand for diagnostic imaging. OMNIPAQUE 140, with its established safety profile and efficacy, is likely to continue playing a significant role in this market.
Regulatory Environment
Regulatory approvals and updates are crucial for the continued success of OMNIPAQUE 140. Recent updates and expansions of indications, such as the approval for oral and rectal administration in pediatrics, have expanded its market potential[1].
Technological Advancements
Advancements in imaging technologies, such as improved CT scanners and digital subtraction angiography, will continue to enhance the diagnostic capabilities of OMNIPAQUE 140. This could lead to increased adoption and usage in various medical settings.
Key Takeaways
- Clinical Trials: OMNIPAQUE 140's safety and efficacy are supported by clinical trials, although specific trials for this concentration are less detailed.
- Market Presence: OMNIPAQUE is a well-established product with a broad range of indications.
- Market Trends: The demand for x-ray contrast media is increasing due to advances in medical technology and an aging population.
- Projections: The market for OMNIPAQUE 140 is expected to grow, driven by its established safety profile, efficacy, and expanding indications.
FAQs
What are the common indications for OMNIPAQUE 140?
OMNIPAQUE 140 is commonly used for intra-arterial digital subtraction angiography, including imaging of the aorta, carotid, femoral, and renal arteries[5].
What are the potential adverse reactions associated with OMNIPAQUE 140?
Potential adverse reactions include hypersensitivity reactions, contrast-induced acute kidney injury, and cardiovascular reactions. However, these are generally mild and transient[4].
Can OMNIPAQUE 140 be used for intrathecal administration?
No, OMNIPAQUE 140 is contraindicated for intrathecal use. Only OMNIPAQUE 180, 240, and 300 are indicated for intrathecal administration[5].
How does OMNIPAQUE 140 compare to other x-ray contrast media?
OMNIPAQUE 140 has a competitive edge due to its nonionic, water-soluble nature and broad range of indications. It has shown comparable or better diagnostic quality images compared to other contrast agents like gastrografin 370[1].
What are the future projections for the market of OMNIPAQUE 140?
The market for OMNIPAQUE 140 is expected to grow, driven by increasing demand for diagnostic imaging, advances in medical technology, and an aging population.
Sources
- Regulatory Decision Summary for Omnipaque - Health Products and Food Branch, Health Canada.
- OMNIPAQUE (iohexol) oral solution - FDA.
- The Society for Vascular Surgery practice guidelines - Journal of Vascular Surgery.
- OMNIPAQUE™ (iohexol) Injection - FDA.
- OMNIPAQUE (iohexol) oral solution - FDA.
