Pancreatic Enzyme Replacement Therapy for Pancreatic-Associated Diarrhea
Pancreatic enzyme replacement therapy (PERT) is highly effective for managing pancreatic-associated diarrhea and should be initiated promptly when exocrine pancreatic insufficiency (EPI) is diagnosed through clinical signs, symptoms, or laboratory tests of malabsorption. 1
Diagnosis of Pancreatic-Associated Diarrhea
- EPI is characterized by inadequate secretion of pancreatic enzymes leading to maldigestion and malabsorption, commonly presenting as steatorrhea, diarrhea, weight loss, and nutritional deficiencies 1
- Fecal elastase test is the most appropriate initial diagnostic test (performed on solid stool specimen); levels <100 μg/g provide good evidence of EPI 1
- Clinical symptoms suggesting EPI include steatorrhea, unexplained weight loss, bloating, excessive flatulence, and deficiencies of fat-soluble vitamins 1, 2
Treatment with PERT
Dosing and Administration
- Initial treatment should be at least 40,000 USP units of lipase with each meal and half that amount (20,000 USP units) with snacks in adults 1
- PERT must be taken during meals, not before or after, to maximize mixing and digestion of nutrients 1
- Dosage should be adjusted based on meal size and fat content 1
Available Formulations
- All FDA-approved PERT products are derived from porcine sources and are equally effective at equivalent doses 1
- Enteric-coated preparations are preferred as they prevent enzyme inactivation by gastric acid 1
- Available FDA-approved formulations include:
- Creon (enteric-coated microspheres): 3,000-36,000 USP lipase units 1
- Zenpep (enteric-coated beads): 3,000-40,000 USP lipase units 1
- Pancreaze (enteric-coated microtablets): 2,600-37,000 USP lipase units 1
- Pertzye (enteric-coated microspheres): 4,000-24,000 USP lipase units 1
- Viokace (non-enteric-coated tablets): 10,444-20,880 USP lipase units (requires acid-reducing agent) 1
Important Considerations
- Over-the-counter pancreatic enzyme supplements should NOT be used as they are unregulated dietary supplements with unknown efficacy and safety 1
- Non-enteric-coated preparations require co-treatment with acid-reducing agents (H2 blockers or proton pump inhibitors) 1
- Acid-reducing agents may also improve efficacy of enteric-coated preparations in some patients 1
Monitoring Treatment Response
- Successful treatment is indicated by 1:
- Reduction in steatorrhea and associated gastrointestinal symptoms
- Weight gain and improved muscle mass/function
- Improvement in fat-soluble vitamin levels
- Regular monitoring should include 1:
- Nutritional status assessment (BMI, muscle mass, fat-soluble vitamins)
- Evaluation of gastrointestinal symptoms
- Assessment of dietary intake and PERT compliance
- Stable patients should have pancreatic disease status assessed at least annually 1
Dietary Considerations
- Low-moderate fat diet with frequent smaller meals is recommended 1
- Very low-fat diets should be avoided 1
- Routine supplementation and monitoring of fat-soluble vitamins (A, D, E, K) is appropriate 1
Clinical Pitfalls to Avoid
- Delaying initiation of PERT when EPI is diagnosed can lead to malnutrition, decreased quality of life, and increased mortality 1
- Administering enzymes before or after meals rather than during meals reduces efficacy 1
- Using inadequate dosage of enzymes may result in continued maldigestion symptoms 1, 2
- Failing to monitor treatment response and adjust dosage accordingly 1, 3
- Neglecting to assess for and treat fat-soluble vitamin deficiencies 1
PERT is a crucial intervention for patients with pancreatic-associated diarrhea due to EPI, with demonstrated efficacy in reducing diarrhea duration, improving nutritional status, and enhancing quality of life 4, 5.