What pancreatic enzyme replacement therapy (PERT) options are available in Malaysia?

Pancreatic Enzyme Replacement Therapy (PERT) Options in Malaysia

In Malaysia, Creon is the primary pancreatic enzyme replacement therapy (PERT) available for patients with exocrine pancreatic insufficiency (EPI). 1, 2

Available PERT Formulations

• Creon is available in Malaysia as enteric-coated microspheres with various lipase strengths (3,000/6,000/12,000/24,000/36,000 USP units) 3
• Creon has demonstrated efficacy in treating EPI due to chronic pancreatitis, pancreatic surgery, and cystic fibrosis 1, 4, 5
• Creon has been shown to be well-tolerated in long-term use (6+ months) with significant improvements in nutritional status and reduction in EPI symptoms 1

Dosing Recommendations

• Initial adult dosing should be 40,000 USP units of lipase with each meal (approximately 500 units/kg/meal) and half that amount (20,000 USP units) with snacks 3, 6
• Dosage should be adjusted based on:
  • Meal size and fat content 3
  • Clinical response (reduction in steatorrhea and GI symptoms) 3
  • Maximum recommended dose: 2,500 units of lipase/kg per meal or 10,000 units/kg/day 6

Administration Guidelines

• PERT must be taken during meals, not before or after, to maximize mixing with food and digestion of nutrients 3, 6
• Capsules can be opened and the contents sprinkled on soft, acidic foods for patients who cannot swallow capsules 6
• For optimal efficacy, PERT should be combined with dietary management including:
  • Moderate fat diet (avoiding very low-fat diets) 3
  • Frequent smaller meals 3
  • Adequate protein intake 6

Monitoring Treatment Efficacy

• Evaluate reduction in steatorrhea and associated gastrointestinal symptoms 3
• Monitor weight gain, muscle mass, and muscle function 3
• Check improvement in fat-soluble vitamin levels (A, D, E, K) 3
• Annual assessment of nutritional status is recommended for stable patients 3
• Consider baseline and follow-up bone density scans every 1-2 years 3

Important Considerations

• Over-the-counter pancreatic enzyme supplements should not be used as they are not standardized or regulated 3
• If response to initial therapy is inadequate, consider:
  • Incorrect timing of enzyme administration 6
  • Inadequate dosing 6
  • Need for acid suppression therapy (especially with non-enteric coated preparations) 3, 6
  • Alternative diagnoses (celiac disease, bacterial overgrowth, bile acid diarrhea) 6

Clinical Outcomes

• Proper PERT treatment significantly improves:
  • Fat and nitrogen absorption 4
  • Stool frequency and consistency 1, 4
  • Abdominal pain and flatulence 1, 4
  • Weight maintenance or gain 1
  • Quality of life 2

Safety Profile

• Creon is generally well-tolerated with adverse events similar to placebo in clinical trials 4, 5
• Most common adverse events are gastrointestinal in nature 4
• Creon has demonstrated safety in various age groups, including children 7