EPI may be overlooked as a diagnosis2
patients were misdiagnosed with another GI condition before being diagnosed with EPI19†
Why the challenge?
- Patients may present with signs and symptoms similar to those of other GI conditions2
- EPI is usually due to another chronic condition the patient is living with2
- 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‡
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
On average, patients receive
4 GI diagnostic tests and
Source: SHS data 2016-2017.
Low EPI knowledge
A lack of awareness and
education about EPI and
enzyme supplementation can
make it difficult for patients to
manage their condition21
46% of adult patients start
on a PERT dose meant for a
patient <100 lb20§
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.
Challenges to Diagnosis
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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.