Optimizing Clinical and Cost Outcomes for Patients on Enteral Nutrition Support for Treatment of Exocrine Pancreatic Insufficiency: Proceedings from an Expert Advisory Board Meeting

Overview of exocrine pancreatic insufficiency (EPI) and related issues The pancreas, an essential part of the gastrointestinal (GI) system, is functionally composed of exocrine and endocrine constituents. Because there is minimal anatomic separation of the exocrine and endocrine pancreatic function, disease states that cause disruption or damage in one component of the organ may lead to defects in the other component.8 EPI is a relatively uncommon but severe condition that is associated with a variety of complex disorders such as cystic fibrosis (CF), pancreatic cancer, gastric/pancreatic surgery, short bowel syndrome, and chronic pancreatitis. Physiological and biochemical effects of EPI include decreased production and secretion of lipase, increased lipase destruction and degradation, and GI motility disorders. The deficiency in pancreatic enzymes (lipase, amylase, protease) results in impaired digestion and subsequent absorption of all nutrients, fats and fat-soluble vitamins being the most clinically relevant.8 Steatorrhea, diarrhea, weight loss, abdominal discomfort, and bloating are hallmarks of EPI. In addition to lifestyle modification (eg, alcohol abstinence, frequent low-volume meals), the typical treatment for EPI is pancreatic enzyme replacement therapy (PERT), the clinical efficacy of which is inconsistent.9 Left untreated, or inadequately controlled, the condition leads to increasingly severe GI symptoms, reduced caloric intake, and inability to gain and/or maintain weight, placing the patient at risk for malnutrition. Malabsorption of fats dramatically increases the risk for malnutrition in patients with EPI.10 Because malnutrition further compromises treatment for the medical conditions underlying EPI, enteral nutrition (EN) becomes a vital therapeutic intervention for stabilizing body mass index (BMI) in some cases.3 EN formulas contain fats as well as carbohydrates, proteins, vitamins, and minerals to help prevent or address nutritional deficiencies related to malabsorption. Nutrition support therapy is more complex than commonly appreciated, particularly when prescribed for patients with EPI. Severely pancreatic insufficient patients are unable to digest and absorb long-chain triglycerides contained in EN formulas – particularly healthy fats such as docosahexanoic acid (DHA) and eicosapentaenoic acid (EPA). Currently, there is no published evidence to support the use of any Food and Drug Administration (FDA)-approved PERT products in enteral feedings, and existing clinical guidelines do not support administration of enzymes by mixing them into EN formulas.3 Factors such as care settings and nutritional formula types must be considered on a case-by-case basis, and complications must be anticipated and avoided; for example, the use of crushed PERT capsule contents in enteral feedings, or capsule contents administered directly though the feeding tube, causes tube clogging and requires frequent monitoring.11 From the patient perspective, some with CF rely on nocturnal EN for adequate caloric intake to maintain and hopefully improve BMI and lung function. Following pancreatic and other GI surgeries, EN is essential for patients who experience gastroparesis and are unable to tolerate oral meals. Lacking an appetite for food, patients with pancreatic cancer often use EN to prevent cachexia. EN is helpful for some patients with cerebral palsy who experience pain while eating solid food.