Introduction to Effective Dosing

In order to achieve the most effective dose for your patients with Pancreatic Exocrine Insufficiency (PEI), a Pancreatic Enzyme Replacement Therapy (PERT) must be able to mimic the physiological conditions of a healthy pancreas. As a result of 100 years of ongoing research and refinements and the launch of Creon®’s unique minimicrospheres in 1993, Creon®’s mode of action closely mimics the physiological process of enzyme delivery. Hence, the correct amount of pancreatic enzymes are delivered to the duodenum intact, where they can be activated with food prior to absorption.

PEI patients are at risk of fat-soluble vitamin deficiencies and malnutrition related complications1, including:

  • reduced quality of life2
  • reduced bone mineral density3
  • cardiovascular events1,4
  • peripheral neuropathy

Normal Pancreatic Exocrine Response

Following a meal pancreatic enzymes are secreted into the duodenum. Approx. 720,000 lipase units are produced per 300-600 kcal meal. The caloric content, nutrient composition and physical properties of a meal influence the degree and duration of the enzyme response.  

Steatorrhoea occurs when over 90% of normal enzyme secretion is lost.  Therefore, steatorrhoea is a symptom of severe PEI.5

Lipase secretion by a healthy pancreas in response to a stimulus of a 300-600 kcal meal

Adapted from Keller J et al. Gut 2005.

Hundreds of thousands of enzymes produced by a healthy pancreas travel to the duodenum where they come into contact with the food substrate and start to break down fats, proteins and carbohydrates into smaller molecules for absorption.

Guidelines and recent data

Published treatment guidelines for chronic pancreatitis and pancreatic cancer recommend initiating patients on 40,000 - 50,000 lipase units per meal and 10,000 – 25,000 lipase units per snack6.

In a study of adult patients taking a median daily dose of 6 x 25,000 units of lipase9:

  • 70% reported steatorrhoea-related symptoms
  • 42% reported weight loss.

Whereas, in a study where patients took Creon doses of 80,000 units of lipase/meal and 40,000 units of lipase/snack they showed improvements from baseline in:

  • fat and nitrogen absorption7,8
  • nutritional laboratory parameters7,8
  • clinical symptoms8
  • quality of life.8

Hence, patients may achieve further benefit by titrating their dose up.6,10,11

References

  1. Toouli J et al. Med J Aust. 2010; 193(8): 461-7.
  2. Ockenga J. HPB 2009; 11(3): 11-5.
  3. Sikkens ECM et al. Best Pract Res Clin Gastroenterol. 2010; 24(3): 337-47.
  4. Domínguez-Muñoz JE et al. J Gastroenterol Hepatol. 2011; 26(Suppl2): 12-6.
  5. Keller J et al. Gut 2005; 54(Suppl6): 1-28.
  6. Imrie CW et al. Ailment Pharmacol Ther. 2010; 32(Suppl1): 1-25.
  7. Thorat V. Ailment Pharmacol Ther. 2012; 36(5): 426-36.
  8. Ramesh H. Pancreatology 2013; 13: 133-9.
  9. Sikkens ECM et al. Pancreatology 2012; 12: 71-73.
  10. Lohr J-M et al. United European Gastroenterol J. 2013; 1(2): 79-83.
  11. Layer P et al. Curr Gastro Rep. 2001; 3: 101-108.

Some patients may achieve further benefit when the dose is increased beyond the starting dose of around 50,000 per meal.3

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