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Gerlud explains unmet needs in EPI, including underdiagnosed patient populations, and the intense pill burdens patients face.
Exocrine Pancreatic Insufficiency (EPI) remains a misunderstood disease, leading to gaps and unmet needs in patient care across multiple etiologies, with clinicians reassessing the future of the therapeutic landscape.
Many clinicians lack awareness of how far-reaching EPI can be, mainly focusing on its presentation in patients with chronic pancreatitis, pancreatic cancer, post–pancreatic resection, and cystic fibrosis. There's an unmet need in identifying EPI in patients with type 1 and 2 diabetes, post-gastric resection and gastric bypass patients, celiac disease, and severe acute pancreatitis, who are at an increased risk.
"The ones that are frequently left behind and that we don't tend to think too much about are patients, for example, with diabetes, type one, type two, patients with gastric resections, patient with gastric bypass that they have a completely normal looking and functional pancreas, but for other reasons, you know, they're developing exocrine pancreatic insufficiency," said Andres Gelrud, MD, a gastroenterologist at Baptist Health Miami Cancer Institute, part of Baptist Health South Florida, in an interview with HCPLive. "So these are conditions actually that we don't tend to think about, but it's very important, because now we do recognize them as patients that may have exocrine pancreatic insufficiency, and starting treatment will have a major impact in their quality of life."
EPI remains an underdiagnosed disease due to its symptoms overlapping with common gastrointestinal disorders, including irritable bowel syndrome and celiac disease, which include bloating, diarrhea, and weight loss. Patients may wait years before approaching a doctor about these symptoms due to their non-specificity and embarrassment to broach the subject of GI issues. Often, symptoms will not manifest until significant pancreatic damage has already occurred, leading to a harder-to-treat patient.
The most commonly utilized test for diagnosing EPI is the fecal elastase-1 (FE-1). However, this test lacks sensitivity for mild to moderate cases, and furthermore, false positives are common when stool is watery or diluted, underscoring the need to interpret results in clinical context. For context, an FE-1 result < 200 µg/g is abnormal, with values < 100 µg/g indicating a high likelihood of EPI and levels between 100 to 200 µg/g indeterminate.
Furthermore, clinicians who treat EPI are witness to the major pill burden their patients face. Right now, pancreatic enzyme replacement therapy has been supported as the best available option, but patients do not find it ideal.
"One of the biggest unmet needs that I see is that patients frequently complain of the number of pills that they have to take, the size of the pill that they have to take,” said Gerlund. “This is an issue that I tend to hear over and over and over."
To address this pill burden, the field would have to discover new pharmaceutical formulations to make disease management easier for patients.
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