Introduction to Cisatracurium Besylate
Cisatracurium besylate is a non-depolarizing neuromuscular blocking agent used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Here, we will delve into the clinical trials, market analysis, and projections for this drug.
Clinical Trials Overview
Adult Patients
The efficacy of cisatracurium besylate in adult patients has been established through several clinical studies. Here are some key findings:
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Studies 1-3: These studies evaluated the drug's effectiveness in providing skeletal muscle relaxation during surgery. Doses of 0.15 mg/kg and 0.2 mg/kg were found to provide clinically effective durations of action of 55 minutes and 61 minutes, respectively, when used with propofol anesthesia. Higher doses of 0.25 mg/kg and 0.4 mg/kg provided longer durations of muscle relaxation, up to 91 minutes, under opioid/nitrous oxide/oxygen anesthesia[1].
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Studies 4 and 5: These studies focused on intubating conditions after administration of cisatracurium besylate. The 0.2 mg/kg dose was found to provide better intubating conditions compared to the 0.15 mg/kg dose when intubation was attempted 90 seconds after drug administration[1].
Pediatric Patients
Clinical trials have also been conducted in pediatric patients:
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Study 6: A dose of 0.1 mg/kg was evaluated in 16 pediatric patients aged 2 to 12 years. Maximum neuromuscular blockade was achieved in an average of 2.8 minutes, with a clinically effective block lasting 28 minutes[1].
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Study 7: A dose of 0.15 mg/kg was evaluated in 50 pediatric patients aged 1 month to 12 years. Maximum neuromuscular blockade was achieved in about 3 minutes for children aged 2 to 12 years and 2 minutes for infants, with clinically effective blocks lasting up to 43 minutes for infants[1].
Intensive Care Unit (ICU) Use
Long-term infusion of cisatracurium besylate in ICU settings has been evaluated:
- Studies 8 and 9: These studies involved patients receiving long-term infusions of cisatracurium besylate. Patients recovered neuromuscular function in approximately 50-55 minutes after the infusion was terminated[1].
Adverse Reactions
Clinical Trials in Surgical Patients
Adverse reactions observed in clinical trials involving surgical patients include:
- Bradycardia: 0.4%
- Hypotension: 0.2%
- Flushing: Less than 1%
- Bronchospasm: Less than 1%
- Rash: Less than 1%[4].
Clinical Trials in ICU Patients
In ICU patients, adverse reactions included:
- Bronchospasm: Reported in one patient.
- Prolonged recovery: Observed in some patients, with recovery times ranging from 167 to 270 minutes[4].
Post-Approval Use
Post-approval use has reported additional adverse events, including anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, and myopathy[4].
Market Analysis
Market Size and Growth
The cisatracurium besylate market has experienced significant growth and is projected to continue this trend:
- The market size was valued at USD billion in 2023 and is anticipated to reach USD billion by 2031, indicating robust growth rates over the forecast period[2][5].
Segmentation
The market is segmented based on:
- Type: Injection and Solution for Injection.
- Application: Neuromuscular Blockade for Surgery and Intensive Care Unit (ICU) Sedation.
- Geography: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[2][5].
Key Players
Prominent companies in the cisatracurium besylate market include:
- Hikma Pharmaceuticals PLC
- Mylan N.V.
- Fresenius Kabi AG
- Teva Pharmaceutical Industries Ltd.
- Pfizer
- Abbvie
- Abbott
- Jiangsu Hengrui Medicine
- Shanghai Pharmaceuticals Holding[2][5].
Market Projections
Forecast Period
The market is expected to see sustained significant expansion from 2023 to 2031. Here are some key projections:
- The market dynamics are influenced by drivers such as increasing demand for neuromuscular blocking agents in surgical and ICU settings, and restraints such as potential adverse reactions and competition from other neuromuscular blockers.
- The report provides a detailed analysis of market trends, including opportunities and challenges, which will impact the market's direction over the forecast period[2][5].
Regional Analysis
The market is expected to grow across various geographical regions, with North America, Europe, and Asia-Pacific being key contributors to the market's growth. The growth in these regions is driven by advanced healthcare infrastructure, increasing surgical procedures, and the need for effective neuromuscular blocking agents[2][5].
Key Takeaways
- Clinical Efficacy: Cisatracurium besylate has been proven effective in providing skeletal muscle relaxation in both adult and pediatric patients, facilitating tracheal intubation and surgery.
- Adverse Reactions: The drug has a profile of adverse reactions that include bradycardia, hypotension, and bronchospasm, among others.
- Market Growth: The market for cisatracurium besylate is expected to grow significantly from 2023 to 2031, driven by increasing demand in surgical and ICU settings.
- Key Players: Several major pharmaceutical companies are involved in the production and distribution of cisatracurium besylate.
FAQs
What is the primary use of cisatracurium besylate?
Cisatracurium besylate is primarily used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
What are the common adverse reactions associated with cisatracurium besylate?
Common adverse reactions include bradycardia, hypotension, flushing, bronchospasm, and rash. Post-approval use has also reported anaphylaxis, histamine release, and prolonged neuromuscular block.
How long does it take for patients to recover from neuromuscular blockade after cisatracurium besylate infusion in ICU settings?
Patients typically recover neuromuscular function in approximately 50-55 minutes after the infusion is terminated.
What is the projected market growth for cisatracurium besylate from 2023 to 2031?
The market is anticipated to grow significantly, with forecasts indicating robust growth rates over the forecast period.
Which companies are major players in the cisatracurium besylate market?
Major players include Hikma Pharmaceuticals PLC, Mylan N.V., Fresenius Kabi AG, Teva Pharmaceutical Industries Ltd., Pfizer, Abbvie, and Abbott, among others.
Sources
- Pfizer Medical Information: "Cisatracurium Besylate Clinical Studies - US"
- Market Research Intellect: "Cisatracurium Besylate Sales Market Size, Scope And Forecast Report"
- Synapse: "Cisatracurium Besylate - Drug Targets, Indications, Patents"
- Pfizer Medical Information: "Cisatracurium Besylate Adverse Reactions - Pfizer Medical Information"
- Market Research Intellect: "Global cisatracurium besylate market size and forcast"
