Introduction
ULTRAVIST 240, an iopromide-based nonionic, iodinated, low osmolar radiological contrast agent, has been a staple in medical imaging for decades. Introduced in Europe in 1985 and in the US in 1995, it is widely used for various intravascular and intravenous indications. Here, we delve into the clinical trials, market analysis, and future projections for ULTRAVIST 240.
Clinical Trials and Efficacy
Overview of Clinical Trials
ULTRAVIST 240 has been evaluated in numerous clinical trials to assess its safety and efficacy across different medical imaging procedures. These trials include:
- Peripheral Venography: Two randomized, double-blind clinical trials involving 63 patients demonstrated excellent visualization ratings and radiologic diagnoses comparable to other low osmolar contrast agents like iohexol and ioversol[4][5].
- Cerebral Arteriography: Trials involving patients with central nervous system diseases showed good to excellent visualization ratings in 99% of the patients, similar to iohexol and iopamidol[4].
- Coronary Arteriography and Left Ventriculography: Studies in patients with altered coronary artery perfusion and ventricular function indicated effective visualization and diagnostic outcomes[4].
- Contrast-Enhanced Computed Tomography (CECT): Trials for CECT of the head and body showed high visualization ratings and diagnostic accuracy, comparable to other contrast agents[4].
Safety Profile
The safety profile of ULTRAVIST 240 has been extensively studied. Common adverse reactions include headache, dysgeusia, abnormal vision, chest pain, and vasodilatation. More severe reactions, though rare, can include anaphylactoid shock, contrast-induced acute kidney injury, and cardiac complications[3][5].
Market Analysis
Global Presence
ULTRAVIST 240 is used in over 100 countries worldwide, reflecting its widespread acceptance and reliability in medical imaging. Its global presence is a testament to its efficacy and safety profile[2].
Market Share and Competition
In the market for radiological contrast agents, ULTRAVIST 240 competes with other low osmolar nonionic agents such as iohexol and iopamidol. However, its long history of use, proven safety, and wide range of indications have helped it maintain a significant market share. The market for contrast agents is growing due to the increasing demand for diagnostic imaging procedures, driven by an aging population and the rise in chronic diseases[2].
Economic Impact
The economic impact of ULTRAVIST 240 is substantial, given its widespread use. It contributes significantly to the revenue of its manufacturer, Bayer, and plays a crucial role in the healthcare sector by enabling accurate diagnoses and treatments. The cost-effectiveness of ULTRAVIST 240, balanced against its efficacy and safety, makes it a preferred choice for many healthcare providers[2].
Market Projections
Growing Demand for Diagnostic Imaging
The demand for diagnostic imaging procedures is expected to increase due to several factors, including an aging population, the rise in chronic diseases, and advancements in medical technology. This trend is likely to drive the demand for contrast agents like ULTRAVIST 240[2].
Technological Advancements
Advancements in imaging technologies, such as improved CT scanners and digital subtraction angiography, will continue to enhance the utility and effectiveness of ULTRAVIST 240. These advancements are expected to further solidify its position in the market[4].
Regulatory Environment
Regulatory approvals and guidelines play a crucial role in the market for pharmaceuticals and medical devices. ULTRAVIST 240 has a strong regulatory backing, having been approved for various indications. Continued compliance with regulatory standards will be essential for its continued market presence[3][4].
Key Indications and Usage
Intra-Arterial Use
ULTRAVIST 240 is indicated for intra-arterial digital subtraction angiography (IA-DSA), peripheral arteriography, and other vascular procedures. Its low viscosity and rapid iodine delivery rate make it particularly suitable for these applications[4].
Intravenous Use
It is also indicated for intravenous use in procedures such as contrast-enhanced computed tomography (CECT) of the head and body, excretory urography, and peripheral venography. The recommended dosages vary based on the specific procedure and patient population[1][4].
Patient Population and Dosage
Adult Dosage
For adults, the recommended dosage for cranial CT scans is 1.5 to 2.5 ml/kg body weight for ULTRAVIST 240. For other procedures like intravenous urography, the dosages are adjusted based on the patient's age and weight[1].
Pediatric Dosage
In pediatric patients, the dosages are tailored to the age and weight of the child. For example, neonates require higher doses relative to their body weight compared to older children and adults[1].
Safety and Side Effects
Common Adverse Reactions
Common side effects include headache, dysgeusia, abnormal vision, and vasodilatation. These reactions are generally mild and transient[3][5].
Severe Adverse Reactions
Severe reactions such as anaphylactoid shock, contrast-induced acute kidney injury, and cardiac complications are rare but can be life-threatening. Patients with a history of severe cutaneous adverse reactions should avoid ULTRAVIST 240[3].
Conclusion
ULTRAVIST 240 remains a vital tool in medical imaging due to its proven safety, efficacy, and wide range of indications. With a strong clinical trial background, significant global presence, and growing demand for diagnostic imaging, it is poised to continue playing a crucial role in the healthcare sector.
Key Takeaways
- Proven Efficacy: ULTRAVIST 240 has been shown to be effective in various clinical trials across different medical imaging procedures.
- Global Presence: It is used in over 100 countries, reflecting its widespread acceptance.
- Safety Profile: While generally safe, it can cause common and rare adverse reactions, necessitating careful patient selection and monitoring.
- Market Projections: The demand for ULTRAVIST 240 is expected to grow due to increasing diagnostic imaging needs and technological advancements.
- Regulatory Compliance: Continued regulatory approvals are crucial for its market presence.
FAQs
What are the common indications for ULTRAVIST 240?
ULTRAVIST 240 is indicated for intra-arterial digital subtraction angiography, peripheral arteriography, contrast-enhanced computed tomography (CECT) of the head and body, excretory urography, and peripheral venography[4].
What are the common side effects of ULTRAVIST 240?
Common side effects include headache, dysgeusia, abnormal vision, and vasodilatation. Severe reactions such as anaphylactoid shock and contrast-induced acute kidney injury are rare but can occur[3][5].
How is ULTRAVIST 240 administered?
ULTRAVIST 240 can be administered intravenously or intra-arterially, with dosages varying based on the specific procedure and patient population[1][4].
Is ULTRAVIST 240 safe for pediatric patients?
Yes, ULTRAVIST 240 is safe for pediatric patients, but the dosages are adjusted based on the child's age and weight. Higher doses relative to body weight are often required for neonates and infants[1].
Can ULTRAVIST 240 be used in patients with renal impairment?
ULTRAVIST 240 can be used in patients with renal impairment, but caution is advised. The drug can be eliminated by hemodialysis, and patients with severe renal impairment may require dose adjustments[1].
What is the market outlook for ULTRAVIST 240?
The market outlook for ULTRAVIST 240 is positive, driven by the increasing demand for diagnostic imaging procedures and technological advancements in medical imaging[2].
Sources
- Bayer, ULTRAVIST 240 10 ml, 50 ml, [PDF].
- MXR Imaging, Ultravist 240 mgl/mL - Contrast for Injection X-Ray CT.
- FDA, ULTRAVIST (iopromide) Injection, for intravenous or intra-arterial use, [PDF].
- FDA, ULTRAVIST - accessdata.fda.gov, [PDF].
- RxList, Ultravist (Iopromide Injection): Side Effects, Uses, Dosage.