EPI is largely a clinical diagnosis1-4*

Patients with EPI may present with signs and symptoms similar to other GI disorders. A careful workup is necessary when suspecting EPI and should include patient history, symptom assessment, and asking about associated conditions. It's also important to get specific details about GI issues, including symptom onset, frequency, and severity, and patient diet.

*Tests can confirm a diagnosis.

Evaluate patients for signs and symptoms of EPI

It is key to take a history in your patients suspected of having EPI since not all patients will present with typical signs and symptoms of EPI. Some patients may limit fat intake to minimize symptoms.3,4

Patients with EPI may present with one or more of the following signs and symptoms4-6:

  • Diarrhea
  • Flatulence
  • Bloating
  • Abdominal pain
  • Unexplained weight loss
  • Steatorrhea

Consider EPI in patients with associated conditions

Think about EPI in patients who have one of the conditions known to be associated with EPI.

Conditions and surgical procedures associated with EPI7-15:

  • Chronic pancreatitis (CP)
  • Cystic fibrosis (CF)
  • Pancreatic cancer
  • Pancreatectomy
  • Gastric surgery
  • Diabetes (type I and IIIC)
  • Obstruction of the biliary or pancreatic duct

Ask your patients specific questions to help them open up about their symptoms

Patients may find it difficult to discuss GI issues with their doctor and may be embarrassed to disclose their symptoms. Because EPI is largely a clinical diagnosis, asking specific questions can help you reach a diagnosis sooner.2*

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  • How urgently do you need to have bowel movements? How frequently?
  • Do you wake in the middle of the night to have a bowel movement? How frequently?
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Stool Details

  • How would you describe your stool? Is it loose? Does it float? Is it greasy? Is the color pale?
  • Does it smell very foul? Is it difficult to flush?
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Other Considerations

  • Have you had any unexplained weight loss?
  • Do you feel like you are managing your symptoms by limiting what you eat?

Code directly for EPI using
ICD-10 code K86.8116

EPI discussion guide icon

An open conversation can reveal the facts

Use the EPI discussion guide to help you reach a diagnosis sooner.*

*Tests can confirm a diagnosis.

Tests that can help confirm a diagnosis of EPI

Non-invasive measures:

  • Fecal elastase concentration (FE-1)2
  • Qualitative fecal fat17
  • Quantitative fecal fat: Standard for fat maldigestion (patient must follow a diet of 100g of fat/day)17,18

Invasive measures:

  • Secretin-pancreozymin stimulation (performed at specialized centers)1

EPI may be overlooked as a diagnosis2

Four total figures are shown, one is highlighted
One in four

patients were misdiagnosed with another GI condition before being diagnosed with EPI19†

Why the challenge?

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  • Patients may present with signs and symptoms similar to those of other GI conditions2
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  • EPI is usually due to another chronic condition the patient is living with2
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  • Patients may find it difficult to discuss GI issues with their doctor and may be embarrassed to disclose their symptoms19†

EPI symptoms may be present for months before diagnosis20‡

Average time from symptom onset to initiation of pancreatic enzyme replacement therapy (PERT) Rx claim20‡

Average time from symptom onset to initiation of pancreatic enzyme replacement therapy in a chart.  Patients with diarrhea take 33.8 months on average before being prescribed PERT.  Patients with abdominal pain generally take 31.9 months, those experiencing weight loss take 14.8 on average and those with pancreatic steatorrhea go on therapy quickly.

Source: SHS data 2016-2017.
N sizes: pancreatic steatorrhea: 5; weight loss: 58; diarrhea: 116; abdominal pain: 161.

Patients face many challenges along their diagnostic journey

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Extensive testing

On average, patients receive
4 GI diagnostic tests and

Source: SHS data 2016-2017.

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Low EPI knowledge

A lack of awareness and
education about EPI and
enzyme supplementation can
make it difficult for patients to
manage their condition21

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PERT dosing

46% of adult patients start
on a PERT dose meant for a
patient <100 lb

Source: SHS data 2015-2017.

EPI Uncovered is based on an online survey conducted by Harris Poll from May 17 through June 20, 2016. It included 1,001 U.S. adults ages 18 and older who experienced at least two gastrointestinal issues, three or more times in the past three months (“patients”), as well as 250 primary care physicians (“PCPs”) and 250 gastroenterologists (“GIs”) in the U.S. who are ages 18 years or older and licensed. Figures for patients were weighted where necessary based on age, education, gender, race/ethnicity, region, income, size of household, marital status, and likelihood to be online to bring them into line with their actual proportions in the population. Figures for PCPs and GIs were weighted on years in practice, gender and region, where necessary, to bring them into line with their actual proportions in the population.

SHS Data, Patients initiating in 2016-H1 and 2017-H2. Time to PERT averages are based on patient’s first occurrence of code of interest in 5-year look-back from initiation. Inclusion criteria: A patient must have had a Mx claim in each year in the last 5 years and at least 1 EPI diagnosis in the last 5 years.


SHS Data. n=sample of 489,890 PERT patients observed between July 2015 and June 2017; only non-CF patients aged 20+ included; prescribed lipase units per day based on each patient's average script size over the 2-year study period.

Learn about EPI management

References: 1. Fieker A, Philpott J, Armand M. Enzyme replacement therapy for pancreatic insufficiency: present and future. Clin Exp Gastroenterol. 2011;4:55-73. 2. Leeds JS, Oppong K, Sanders DS. The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011;8(7):405-415. 3. Durie P, Baillargeon JD, Bouchard S, Donnellan F, Zepeda-Gomez S, Teshima C. Diagnosis and management of pancreatic exocrine insufficiency (PEI) in primary care: consensus guidance of a Canadian expert panel. Curr Med Res Opin. 2018;34(1):25-33. 4. Domínguez-Muñoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Curr Gastroenterol Rep. 2007;9(2):116-122. 5. Ferrone M, Raimondo M, Scolapio JS. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-920. 6. Alkaade S, Vareedayah AA. A primer on exocrine pancreatic insufficiency, fat malabsorption, and fatty acid abnormalities. Am J Manag Care. 2017;23(suppl 12):203S-209S. 7. Keller J, Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(suppl 6):1-28.
8. Yuasa Y, Murakami Y, Nakamura H, et al. Histological loss of pancreatic exocrine cells correlates with pancreatic exocrine function after pancreatic surgery. Pancreas. 2012;41(6):928-933.
9. Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003;26(suppl 1):5S-20S. 10. Hardt PD, Hauenschild A, Jaeger C, Teichmann J, Bretzel RG, Kloer HU; for the S2453112/S2453113 Study Group. High prevalence of steatorrhea in 101 diabetic patients likely to suffer from exocrine pancreatic insufficiency according to low fecal elastase 1 concentrations: a prospective multicenter study. Dig Dis Sci. 2003;48(9):1688-1692. 11. Cavalot F, Bonomo K, Fiora E, et al. Does pancreatic elastase-1 in stools predict steatorrhea in type 1 diabetes? Diabetes Care. 2006;29(3):719-721. 12. Hahn JU, Kerner W, Maisonneuve P, Lowenfels AB, Lankisch PG. Low fecal elastase 1 levels do not indicate exocrine pancreatic insufficiency in type-1 diabetes mellitus. Pancreas. 2008;36(3):274-278. 13. Bures J, Cyrany J, Kohoutova D, et al. Small intestinal bacterial overgrowth syndrome. World J Gastroenterol. 2010;16(24):2978-2990. 14. Czakó L, Hegyi P, Rakonczay Z, Wittmann T, Otsuki M. Interactions between the endocrine and exocrine pancreas and their clinical relevance. Pancreatology. 2009;9(4):351-359. 15. Hackert T, Schütte K, Malfertheiner P. The pancreas: causes for malabsorption. Viszeralmedizin. 2014;30(3):190-197. 16. Centers for Disease Control and Prevention. ICD-10 Coordination and Maintenance Committee Meeting, March 18-19, 2015. 17. Hammer HF. Pancreatic exocrine insufficiency: diagnostic evaluation and replacement therapy with pancreatic enzymes. Dig Dis. 2010;28(2):339-343. 18. Mayo Foundation for Medical Education and Research. Test ID: FATF - Specimen: Fat, Feces. Mayo Clinic website. http://www.mayomedicallaboratories.com/test-catalog/Specimen/8310. Accessed October 2, 2018. 19. EPI Uncovered. American Gastroenterological Association website. https://www.gastro.org/press-release/largest-analysis-examining-barriers-to-epi-diagnosis-finds-patients-with-digestive-health-issues-overlook-their-symptoms. Published October 24, 2016. Accessed December 4, 2018. 20. Data on file. AbbVie Inc. Source: SHS data (2015-2017), 2017. 21. Data on file. Ruder Finn GI Symptoms Study (by Harris Interactive); 2013.