Frequently Asked Questions
Below you’ll find answers to the most common questions about PERT for exocrine pancreatic insufficiency.
PERTs are pancreatic enzyme preparations consisting of pancrelipase, an extract containing multiple animal-derived enzyme classes, including lipases, proteases, and amylases.1 PERT is the cornerstone of treatment for EPI.2
The pancreatic enzymes in PERTs catalyze the hydrolysis of fats to glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.1
PERT is orally administered as capsules or tablets and is taken during meals or snacks, with sufficient fluid. PERT should be swallowed whole and should not be crushed or chewed.1
PERT may be dosed based on fat ingestion or actual body weight. The initial starting dose and increases in the dose should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.1
In children >4 years and in adults, enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or <10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.1
Usually, half of the prescribed dose for an individualized full meal should be given with each snack.1
No. The measure of fecal elastase-1 cannot be used to determine efficacy of PERT.3,4
Constipation can manifest as a symptom of EPI, although it is less commonly observed compared to diarrhea.5
EPI is characterized by the inadequate production or release of pancreatic enzymes, which are necessary for the proper digestion and absorption of nutrients. When these enzymes are deficient, it can lead to malabsorption and subsequent gastrointestinal symptoms.5
In some cases, the diminished enzyme activity can impede the digestion and movement of food through the digestive tract, leading to delayed transit time and constipation. This can be attributed to the inadequate breakdown of fats, proteins, and carbohydrates, which can adversely affect the overall digestive process. EPI may also be masked by the use of certain medications that cause constipation such as certain pain medications.5
The goal of medical management for patients with EPI is to replace digestive enzymes in order to restore proper nutrient digestion and facilitating absorption. Several outcomes can be assessed to evaluate response to PERT, including gastrointestinal symptoms, nutritional parameters, and stool fat content. EPI-related gastrointestinal symptoms such as diarrhea, abdominal pain, bloating, and malabsorption may be expected to improve with PERT and may require dose titration if clinical symptoms persist. Patients should also be monitored for nutritional parameters, such as body weight, body mass index (BMI), and in some cases essential vitamin and mineral levels during PERT treatment. Additionally, evaluating the reduction or normalization of fat content in the stool serves as an indicator of PERT’s efficacy in enhancing fat digestion and absorption. It is important to individualize the evaluation process based on each patient’s specific circumstances and symptoms. Regular follow-up appointments are recommended to monitor the response to PERT and make any necessary adjustments to the treatment plan.
If a patient with EPI does not respond to PERT, several next steps can be considered including:
Adjusting the PERT dosage: It is imperative that the patient is taking the correct dosage of PERT. If the dosage is too low, it may not adequately address the underlying EPI. Therefore, adjusting the PERT dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet may be necessary. Changes in dosage may need an adjustment period of several days.1
Investigating other underlying conditions: If the patient does not respond to PERT, it may be necessary to investigate other underlying conditions that may be contributing to their symptoms. For example, small intestinal bacterial overgrowth (SIBO) or celiac disease can cause similar symptoms to EPI and may require different treatment approaches.1
Referral to a specialist: If the patient does not respond to PERT, referral to a specialist, such as a gastroenterologist or a pancreatic specialist, may be necessary. These specialists can perform additional tests and provide more specialized care to manage the patient’s symptoms.1
Over-the-counter (OTC) digestive enzymes are not the same as PERT. While both types of enzymes aid in the digestion of food, OTC pancreatic enzymes are not considered pancrelipase products and have reduced quantities and different ratios of enzymes.1
OTC pancreatic enzymes, which are classified as dietary supplements, are not recommended for use in patients with EPI. This is because the FDA does not control their production, and the safety and efficacy of these supplements cannot be guaranteed for patients with EPI.1
Prescription PERT, on the other hand, is an FDA-approved medication specifically indicated for treatment of EPI in adult and pediatric patients. It consists of pancrelipase, an extract containing porcine-derived enzymes, including lipases, proteases, and amylases. These enzymes catalyze the hydrolysis of fats, proteins, and starches in the duodenum and proximal small intestine, mimicking the digestive enzymes secreted by the pancreas.1
