Pancreatic Enzyme Replacement Therapy (PERT): Porcine vs. Bovine Source
All commercially available pancreatic enzyme replacement therapy (PERT) products in the United States are of porcine origin, making porcine-derived enzymes the preferred and only FDA-approved source for treating pancreatic insufficiency. 1
Current Available PERT Products
- All FDA-approved PERT products (Creon, Zenpep, Pancreaze, Pertzye, and Viokace) are derived from porcine pancreas and contain varying concentrations of lipase, amylase, and proteases 1
- These products are labeled based on their USP lipase content, which is the primary enzyme needed for fat digestion 1
- Creon specifically is a porcine-derived product available in multiple lipase strengths (3,000-36,000 USP units) as enteric-coated microspheres 2
Why Porcine Enzymes Are Preferred
- Porcine pancreatic enzymes have been extensively studied and have demonstrated efficacy in treating exocrine pancreatic insufficiency (EPI) 1
- The enteric-coated formulations protect the enzymes from gastric acid degradation, allowing them to be released in the duodenum at pH >5.5 1
- Mini-microspheres (1.0-1.2 mm) have shown higher therapeutic efficacy compared to larger microspheres 1
Bovine vs. Porcine Considerations
- There are no FDA-approved bovine pancreatic enzyme products for treating EPI 1
- While bovine bile has been mentioned in research contexts for specific laboratory applications 1, this does not extend to therapeutic use for pancreatic insufficiency
- Over-the-counter enzyme supplements (which might include bovine-derived products) should not be used as they are classified as dietary supplements only, with unstandardized dosing, unregulated efficacy, and unknown safety 1
Clinical Implications and Recommendations
- Untreated EPI results in maldigestion symptoms, nutritional deficiencies, poor quality of life, and increased mortality 1
- Initial PERT dosing should be at least 40,000 USP units of lipase during each meal in adults and half that with snacks 1
- PERT should be taken during meals to maximize mixing with food and digestion of nutrients 1
- The different FDA-approved porcine enzyme products are generally considered equipotent at similar lipase dosages 1
- Switching between different porcine enzyme products is typically based on insurance coverage rather than efficacy differences 1
Special Considerations
- For patients with allergies to porcine proteins, caution should be exercised when administering porcine-derived PERT 2
- Monitoring of fat-soluble vitamin levels is appropriate for patients on PERT 1
- High-dose PERT (>2,500 lipase units/kg/meal or >10,000 lipase units/kg/day) should be used with caution due to risk of fibrosing colonopathy, particularly in children 2
- Success of PERT is measured by reduction in steatorrhea, weight gain, improvement in muscle mass and function, and normalization of fat-soluble vitamin levels 1
In conclusion, porcine-derived pancreatic enzymes are the standard of care for treating pancreatic insufficiency, with no FDA-approved bovine alternatives currently available for clinical use 1, 2.