Treatment of Pancreatic Insufficiency
The primary treatment for pancreatic insufficiency is pancreatic enzyme replacement therapy (PERT) with FDA-approved formulations, administered at a dose of at least 40,000 USP units of lipase with each meal and 20,000 USP units with snacks in adults, taken during meals to maximize efficacy. 1, 2
Diagnosis and Assessment
Before initiating treatment:
- Confirm exocrine pancreatic insufficiency (EPI) through appropriate testing
- Assess nutritional status including:
- Body mass index (BMI)
- Fat-soluble vitamin levels (A, D, E, K)
- Baseline dual-energy x-ray absorptiometry (DEXA) scan 1
PERT Administration Protocol
Dosing Guidelines
- Initial adult dose: 40,000 USP units of lipase per meal
- Snacks: 20,000 USP units of lipase
- Timing: Take during meals (not before or after) to maximize mixing with food 1, 2
- Adjust dose based on:
- Meal size
- Fat content of meal
- Clinical response
FDA-Approved PERT Products
All commercially available products are porcine-derived and available in various formulations:
| Brand | Type | Available Lipase Strengths (USP) |
|---|---|---|
| Creon | Enteric-coated microspheres | 3,000/6,000/12,000/24,000/36,000 |
| Zenpep | Enteric-coated beads | 3,000/5,000/10,000/15,000/20,000/25,000/40,000 |
| Pancreaze | Enteric-coated microtablets | 2,600/4,200/10,500/16,800/21,000/37,000 |
| Pertzye | Enteric-coated microspheres | 4,000/8,000/16,000/24,000 |
| Viokace | Non–enteric-coated tablets | 10,444/20,880 |
| Relizorb | In-line lipase cartridge | For enteral feeding formulas |
Important Clinical Considerations
Dietary Recommendations
- Low to moderate fat diet with frequent smaller meals
- Avoid very low-fat diets as they may worsen malnutrition 1
Monitoring Treatment Efficacy
Monitor for:
- Reduction in steatorrhea and GI symptoms
- Weight gain/maintenance
- Improvement in muscle mass and function
- Normalization of fat-soluble vitamin levels 1, 2
Frequency of Monitoring
- Stable patients: Assess pancreatic disease annually
- Measure fat-soluble vitamins, nutritional markers, and screen for diabetes with HbA1c
- Repeat DEXA scan every 1-2 years 1
Treatment Optimization Strategies
If symptoms persist despite adequate PERT dosing:
- Add acid-reducing agents: H2-blockers or proton pump inhibitors may improve efficacy of enzymes
- Consider switching PERT products or adding non-enteric coated enzymes
- Adjust timing: Ensure enzymes are taken during meals, not before or after 1, 2, 3
Important Cautions
- Do not use over-the-counter enzyme supplements: They lack standardization, regulation, and have unknown efficacy and safety 1, 2
- Non-enteric coated formulations (e.g., Viokace) require co-administration with acid-reducing agents 2
- Consider pharmaceutical benefit plans as PERT can be expensive 2
Special Populations
For infants and children:
- Adjust dosing based on weight and age
- Monitor growth at every clinic visit for infants
- Monitor every 3 months for older children and adolescents 1
For patients receiving enteral nutrition:
- Use specialized formulations like Relizorb for tube feedings
- Administer enzymes as bolus doses through feeding tubes rather than mixing with formula 1