Is a fecal elastase (FE) test necessary before increasing the dose of Creon (pancreatic enzymes)?

From the Guidelines

A fecal elastase (FE) test is necessary before increasing the dose of Creon (pancreatic enzymes) to ensure adequate pancreatic enzyme replacement therapy and prevent complications related to fat malabsorption and malnutrition. According to the most recent and highest quality study 1, the fecal elastase test is the most appropriate initial test for diagnosing exocrine pancreatic insufficiency (EPI) and can be performed while the patient is on pancreatic enzyme replacement therapy.

Key Points to Consider

• The fecal elastase test measures the amount of pancreatic elastase enzyme in the stool, which helps determine if pancreatic enzyme replacement therapy is adequate 1.
• A low fecal elastase level (typically less than 100 mg/g of stool) provides good evidence of EPI, and levels of 100–200 mg/g are indeterminate for EPI 1.
• Before increasing the dose of Creon, it's essential to ensure the patient is taking the medication correctly—with meals and snacks, not crushing or chewing the capsules, and storing properly 1.
• The typical starting dose of Creon is at least 40,000 USP units of lipase during each meal in adults, and one-half of that with snacks, which can be adjusted based on symptoms and lab results 1.
• Dosage adjustments should be made gradually, monitoring for symptom improvement such as reduced steatorrhea, weight gain, and decreased abdominal discomfort 1.

Monitoring and Adjustments

• Routine supplementation and monitoring of fat-soluble vitamin levels are appropriate, and dietary modifications include a low-moderate fat diet with frequent smaller meals and avoiding very-low-fat diets 1.
• The use of PERT in patients with EPI improves outcomes, and failure to properly provide PERT in adequate doses results in a continuation of maldigestion symptoms, micro- or macro-nutritional deficiencies, poor quality of life, and increased mortality 1.

From the Research

Fecal Elastase Test Necessity

• The necessity of a fecal elastase (FE) test before increasing the dose of Creon (pancreatic enzymes) can be evaluated based on its diagnostic performance in detecting exocrine pancreatic insufficiency (EPI) 2.
• Studies have shown that the FE test is a reliable and non-invasive method for evaluating pancreatic function, with a high sensitivity and specificity in detecting EPI 3, 4.
• However, the FE test may not be suitable for screening patients with a low pre-test probability of EPI, as it may have a high false-positive rate 2.
• In patients with chronic pancreatitis, the FE test has been shown to be a sensitive test for detecting PEI, but it may not have a good agreement with the 72-h stool for fecal fat estimation (FFE) 5.

Diagnostic Performance of Fecal Elastase Test

• The diagnostic performance of the FE test has been evaluated in several studies, with pooled sensitivity and specificity values ranging from 0.77 to 0.96 and 0.88 to 0.93, respectively 2.
• The FE test has been shown to be highly sensitive in detecting severe and moderate exocrine pancreatic insufficiency, but its specificity is lower 3.
• The test has been compared to other diagnostic methods, such as the secretin stimulation test and FFE, and has been found to be a reliable alternative for detecting EPI 4, 5.

Clinical Applications of Fecal Elastase Test

• The FE test may be used as a screening test for PEI in patients with chronic pancreatitis, due to its high sensitivity and non-invasive nature 5.
• However, the test may not be suitable for patients with a low pre-test probability of EPI, and its results should be interpreted with caution in these cases 2.
• The FE test may be useful in monitoring patients with EPI and adjusting their pancreatic enzyme replacement therapy accordingly 4.