Introduction
Insulin Susp Protamine Zinc (PZI), particularly in its recombinant human form, has been a significant focus in veterinary medicine, especially for the treatment of diabetes mellitus in dogs and cats. This article will delve into the clinical trials, market analysis, and future projections for this insulin preparation.
Clinical Trials and Efficacy
Background and Hypothesis
The need for alternative insulin preparations arose following the withdrawal of purified pork source lente insulin by the FDA in 2009. Recombinant human protamine zinc insulin (rhPZI), marketed as ProZinc, was initially approved for feline diabetes but has since been evaluated for its efficacy in canine diabetes[1][2].
Study Design and Methods
A prospective clinical trial involving 17 dogs (6 newly diagnosed and 11 insulin-treated diabetics) was conducted to assess the efficacy of rhPZI. Dogs were treated with rhPZI for 60 days, with glycemic control evaluated through history, physical examination, body weight, serum fructosamine concentration, and blood glucose concentrations measured at various intervals[1][2].
Results
The trial demonstrated that rhPZI significantly decreased both 10-hour mean blood glucose and serum fructosamine concentrations by day 60. Specifically, the 10-hour mean blood glucose decreased from 457 mg/dL to 299 mg/dL, and serum fructosamine concentrations decreased from 557 mg/dL to 478 mg/dL. Clinical signs such as polyuria and polydipsia improved in 14 of the 17 dogs, and body weight was stable or increased in 16 dogs. Hypoglycemia was the only consistent adverse event observed[1][2].
Conclusions
The study concluded that rhPZI is effective in treating diabetic dogs and can be considered an alternative treatment for dogs poorly controlled with other insulin preparations. The prolonged duration of action of PZI, however, may lead to hypoglycemia and the Somogyi response in some dogs[1][2].
Market Analysis
Current Market Status
ProZinc, the recombinant human PZI insulin, is the only AAHA-recommended and FDA-approved first-line treatment for feline diabetes. Its use in canine diabetes, although not the primary indication, has been gaining traction due to its efficacy and the need for alternative insulin preparations[4].
Market Demand
The demand for effective insulin treatments in veterinary medicine is high, particularly given the increasing incidence of diabetes in pets. The withdrawal of purified pork source lente insulin and the limitations of recombinant human NPH insulin have created a market gap that PZI insulin can fill[1][2].
Cost Considerations
One of the significant drawbacks of using ProZinc in dogs is the relatively high cost, especially for larger breed dogs that require higher doses. This cost factor can influence market adoption and patient compliance[1].
Market Projections
Growth Potential
Given the efficacy of PZI insulin in both feline and canine diabetes, there is significant growth potential in the veterinary insulin market. As more veterinarians become aware of the benefits of PZI insulin, its adoption is likely to increase, particularly in cases where other insulin preparations are ineffective.
Competitive Landscape
The veterinary insulin market is competitive, with various insulin preparations available. However, the unique characteristics of PZI insulin, such as its prolonged duration of action and effectiveness in achieving glycemic control, position it as a strong contender. The AAHA recommendation and FDA approval for feline use further enhance its market standing[4].
Future Developments
Future studies and clinical trials may focus on optimizing the dosage and administration of PZI insulin to minimize adverse events like hypoglycemia. Additionally, cost-effective strategies and patient assistance programs could be developed to make this treatment more accessible to a broader range of pet owners.
Clinical Implications and Recommendations
Starting Dose and Administration
Based on the clinical trials, a starting dose of 0.5 U/kg, administered twice daily, is recommended for diabetic dogs. Adjustments in dosage should be made as needed to achieve optimal glycemic control[1][2].
Monitoring and Adverse Events
Regular monitoring of blood glucose and serum fructosamine concentrations is crucial. Hypoglycemia is a significant adverse event, and veterinarians should be vigilant in managing this risk, especially when administering PZI insulin twice daily[1][2].
Key Takeaways
- Efficacy: Recombinant human PZI insulin (ProZinc) is effective in treating diabetic dogs and can be used as an alternative to other insulin preparations.
- Market Demand: High demand exists for effective insulin treatments in veterinary medicine, driven by the increasing incidence of diabetes in pets.
- Cost Considerations: The relatively high cost of ProZinc, especially for larger breed dogs, is a significant factor to consider.
- Growth Potential: Strong growth potential in the veterinary insulin market due to the unique benefits of PZI insulin.
- Clinical Implications: Regular monitoring and dose adjustments are necessary to manage glycemic control and minimize adverse events.
FAQs
Q: What is the primary indication for ProZinc insulin?
A: ProZinc insulin is primarily indicated for the treatment of feline diabetes mellitus but has also been found effective in treating canine diabetes.
Q: What are the key benefits of using PZI insulin in dogs?
A: PZI insulin offers prolonged duration of action, significant reduction in blood glucose and serum fructosamine concentrations, and improvement in clinical signs such as polyuria and polydipsia.
Q: What are the potential adverse events associated with PZI insulin in dogs?
A: Hypoglycemia is the most consistent adverse event observed with the use of PZI insulin in dogs.
Q: How is the dosage of PZI insulin adjusted in dogs?
A: The dosage of PZI insulin should be adjusted based on regular monitoring of blood glucose and serum fructosamine concentrations to achieve optimal glycemic control.
Q: Is ProZinc insulin cost-effective for larger breed dogs?
A: The high cost of ProZinc insulin, particularly for larger breed dogs requiring higher doses, can be a significant drawback and may affect patient compliance.
References
- Maggiore A. Della, Nelson R. W., Dennis J., Johnson E., Kass P. H. "Efficacy of Protamine Zinc Recombinant Human Insulin for Controlling Hyperglycemia in Dogs with Diabetes Mellitus." Journal of Veterinary Internal Medicine, vol. 26, no. 1, 2012, pp. 109-115.
- Maggiore A. Della, et al. "Efficacy of Protamine Zinc Recombinant Human Insulin for Controlling Hyperglycemia in Dogs with Diabetes Mellitus." Journal of the American Animal Hospital Association, 23 Dec 2011.
- Sanofi Press Release. "TZIELD® Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents." Sanofi, 18 Oct 2023.
- Boehringer Ingelheim Vetmedica. "PROZINC® (protamine zinc recombinant human insulin) for Diabetes." BI-Animal Health, 2023.
