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Understand: Chapter 1. PEI: What is it and what’s the issue?

Patients with pancreatic exocrine insufficiency (PEI)

  • PEI occurs when the pancreas does not produce enough digestive enzymes1
  • Patients with PEI usually present with abdominal pain/discomfort, diarrhoea and unintentional weight loss1
  • PEI is a major consequence of numerous other serious conditions (pancreatic and non-pancreatic) including cystic fibrosis, chronic pancreatitis, pancreatic cancer and gastrointestinal surgery. It may also be an important consequence in coeliac disease, irritable bowel syndrome or Crohn’s disease1
  • PEI is therefore an extra burden for patients who are already sick

Understand: Chapter 1. PEI: What is it and what’s the issue?

Which patients are at risk of PEI?

PEI may go undetected because the signs and symptoms are similar to those of other gastrointestinal diseases2

PEI frequently accompanies common conditions

94%
Chronic pancreatits3
>80%
Pancreatic cancer4
91%
Cystic fibrosis5

Emerging evidence suggests that PEI is also prevalent in:*

46-57%
Diabetes mellitus Type I6,7**
30-35%
Diabetes mellitus Type II7,8**
30%
Inflammatory bowel disease10
15%
Coeliac disease11
6%
Diarrhoea predominant IBS12
14%
Crohn’s disease13

*Using faecal elastase screening (discussed further in chapter 2). All studies used cut-off points <200 µg/g FE-1 to indicate potential PEI

**9.2% of diabetes is secondary to pancreatic disease9

Understand: Chapter 1. PEI: What is it and what’s the issue?

Consequences of not identifying patients with PEI

PEI increases the risk of malnutrition, which in turn affects mortality, morbidity and quality of life14

Lack of digestion leads to an inadequate absorption of nutrients1

Left undiagnosed or insufficiently treated PEI can lead to:15

  • Weight loss, malnutrition and fat soluble vitamin deficiencies (A, D, E, and K)
  • Increased risk of osteoporosis and peripheral neuropathy....................
  • Increased risk of cardiovascular (CV) events...................

Understand: Chapter 1. PEI: What is it and what’s the issue?

Overview of PEI diagnosis

Professor Domínguez-Muñoz
Director, Department of Gastroenterology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

The views expressed are of the healthcare professional and not the hospital where they work. See Disclaimer for more information.

Understand: Chapter 2. How to address the problem: testing for PEI

Tests are available to diagnose PEI

Patients with abdominal pain/discomfort, diarrhoea and unintentional weight loss should be tested for PEI1

  • Several tests are available, which vary in their robustness and cost1
  • Although invasive tests are the most sensitive and specific methods to assess pancreatic exocrine function, their cost and invasive nature limit their routine use in clinical practice1
  • Non-invasive tests have gained popularity in the clinical setting and will be discussed in further detail

Understand: Chapter 2. How to address the problem: testing for PEI

Tests for PEI

  • The British Society of Gastroenterology guidelines on chronic diarrhoea recommend that all clinical centres should have access to at least one non-invasive pancreatic function test, with the faecal elastase being the preferred test18
  • Positive screening results for pancreatic disease can be confirmed with various imaging techniques such as endoscopic ultrasound or computed tomography19

Understand: Chapter 2. How to address the problem: testing for PEI

Faecal elastase screening for pancreatic function

Measures the amount of the pancreatic exocrine elastase-1 enzyme in the stool15

Requires a single stool sample and is relatively simple to perform, making this test popular in clinical practice15

Faecal elastase-1 levels are quantified with an ELISA*1

Sensitivity15

~100% in severe
pancreatic disease
77-100% in moderate
pancreatic disease
0-63% in mild
pancreatic disease

Specificity15

~93% (can give false positives in patients with diarrhoea)
Detection1
<200 µg/g stool
= mild pancreatic disease
<100 µg/g stool
= severe pancreatic disease
*enzyme-linked immunosorbent assay

Understand: Chapter 2. How to address the problem: testing for PEI

Faecal fat test for PEI

Three-day faecal fat test is the gold standard for diagnosing and quantifying steatorrhoea (presence of excess fat in faeces), a key indicator of maldigestion1

The odious nature of this test makes it very unpopular with both patients and laboratory technicians11

Co-efficient of fat absorption is calculated from a 72-hour faecal fat quantification1

Patients keep to a strict diet of 100 g fat/day for 3–5 days Total quantity of faeces excreted during 3–4 days are collected and pooled for analysis

Steatorrhoea is present if the percentage of ingested fat subsequently excreted is:

<7% in patients over 6 months of age

<15%% in patients under 6 months of age

Understand: Chapter 2. How to address the problem: testing for PEI

Breath test for PEI

Measures the metabolism of a 13C-substrate by pancreatic enzymes20

This test is easily applicable in clinical practice and is highly robust and reproducible20

A labelled substrate (13C-mixed triglyceride; MTG) is given orally with a test meal20

  • A proportion of substrates are metabolised by pancreatic enzymes
  • Further metabolism of these products yields 13CO2 which is released with expired air
  • The amount of 13CO2 in the expired air can be measured by mass spectrometry or infrared analysis and relates to pancreatic function

Sensitivity for the diagnosis of fat maldigestion is higher than 90%2

How the breath test works

Understand: Chapter 2. How to address the problem: testing for PEI

Overview of PEI testing

Professor Domínguez-Muñoz
Director, Department of Gastroenterology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

Professor David Sanders
Consultant Gastroenterologist, Royal Hallamshire Hospital and University of Sheffield, UK

The views expressed are of the healthcare professional and not the hospital where they work. See Disclaimer for more information.

Understand: Chapter 3. How to address the problem: treating PEI

Pancreatic enzyme replacement therapy (PERT) is the main treatment for PEI1

  • Orally administered enzymes facilitate the digestion of fats, proteins and carbohydrates to replace the missing pancreatic digestive enzymes1
  • Management of PEI may extend beyond PERT to include the following:21
    • Lifestyle modifications (e.g. frequent and low-volume meals, avoiding food that is difficult to digest, limitation of alcohol intake)
    • Vitamin supplementation (primarily the fat-soluble vitamins A, D, E, and K)

Understand: Chapter 3. How to address the problem: treating PEI

How does PERT work?22

Understand: Chapter 3. How to address the problem: treating PEI

The correct PERT dose is essential for effective treatment

Dosing varies from individual to individual, depending on the degree of maldigestion and fat content of the meal22

Current recommendations for adults suggest a starting dose around 50,000 lipase units per main meal and around 25,000 lipase units per snack1,1,4,15,23,27,28

More information on dosing for infants
and children can be found here..............

Understand: Chapter 3. How to address the problem: treating PEI

Selecting the correct PERT dose is essential for effective treatment

Dosing varies from individual to individual, depending on the degree of maldigestion and fat content of the meal22

  • While different patients may have the same or similar starting doses, the dose should be titrated according to the individual’s response and experience...........
  • Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.25,29,30,31
  • To help patients understand their dose, they should understand the rationale behind PERT dosing, e.g. the relevance to physiological pancreatic enzyme production24

Understand: Chapter 3. How to address the problem: treating PEI

Overview of PEI testing

Professor Domínguez-Muñoz
Director, Department of Gastroenterology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

The views expressed are of the healthcare professional and not the hospital where they work. See Disclaimer for more information.

Understand: Optimising management of Pancreatic Exocrine Insufficiency

Now you have completed this section, you should understand:

Which patients are at risk of PEI?

How PEI is diagnosed

How PEI is optimally treated

Early detection and optimum treatment of PEI are essential to relieve symptoms and normalise nutritional status1,26

1
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UNDERSTAND PEI

Three Chapters Addressing unmet needs in the UK
2
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PATIENT CASES

An opportunity to test your knowledge on managing patients with PEI
3
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ACTION

A selection of useful tools and resources to support your management of patients with PEI