Pancreatic Enzyme Replacement Therapy in Pancreatic Exocrine Insufficiency-Real-World's Dosing and Effectiveness: A Systematic Review.

BACKGROUND

Pancreatic exocrine insufficiency (PEI) results from impaired exocrine function of the pancreas, causing distressing symptoms like steatorrhea, diarrhea, abdominal distention, bloating, and pain. Treatment involves pancreatic enzyme replacement therapy (PERT), yet compliance with clinical guidelines and its real-world effectiveness are unclear. This systematic review aimed to assess the concordance between real-world PERT doses and clinical guidelines and to evaluate the effectiveness of PERT doses, considering their average administration.

METHODS

A systematic search of MEDLINE and EMBASE up to June 2023 identified observational studies reporting PERT doses and their effects on diarrhea and nutrition in PEI patients. Studies were classified based on adherence to current clinical guidelines for PERT dosing.

RESULTS

Twenty-five observational studies involving 3818 patients met the inclusion criteria. In 40% of the studies, average PERT doses were lower than the recommended 40,000-50,000 lipase units (LU) per meal. Significant alleviation of diarrhea was observed in nearly all studies with lower-than-recommended doses, but none showed benefits in nutritional status. PERT doses compliant with guidelines helped reduce diarrhea in most studies and improved or maintained nutritional status.

CONCLUSIONS

This review revealed that real-world PERT doses were lower than European guidelines in 40% of studies. While lower doses alleviated gastrointestinal symptoms, they were insufficient for maintaining normal nutritional status. Therefore, PERT dosing should aim for nutritional improvement by adhering to guideline-recommended doses. Individualized dosing, considering both symptom management and nutritional status, is essential due to varying responses to treatment.