Abstract / Summary
Background: Pancreatic exocrine insufficiency (PEI) is a maldigestion syndrome leading to symptoms and nutritional deficiencies. Prospective real-world data on pancreatic enzyme replacement therapy (PERT) dose requirements across aetiologies are limited.
Objective: To define PERT dose requirements and treatment outcomes across PEI aetiologies in specialist European practice.
Methods: EURO-PEI was a multicentre observational registry with predominantly prospective data collection conducted at eight pancreatic centres in five European countries between June 2021 and September 2025. Adults with clinician-established PEI in whom PERT was initiated or actively optimised were included. The primary outcome was the optimised PERT dose associated with the achievement of a clinician-assessed therapeutic goal: improvement or resolution of PEI-related symptoms with normalisation or clinically relevant improvement of nutritional abnormalities.
Results: Among 1015 patients, PEI was secondary to chronic pancreatitis in 496 (48.9%), pancreatectomy in 185 (18.2%), pancreatic cancer in 174 (17.1%), and acute pancreatitis in 95 (9.4%). Median total daily optimised doses were highest after pancreatectomy (240,000 PhU, IQR 175,000-375,000) and in pancreatic cancer (210,000 PhU, 175,000-325,000), compared with chronic pancreatitis (175,000 PhU, 120,000-210,000) and acute pancreatitis (100,000 PhU, 75,000-200,000). After optimisation, the therapeutic goal was achieved in 951 patients (93.7%); of these, 446 (46.9%) required enzyme doses exceeding commonly recommended starting doses. Related adverse events occurred in 38 patients (3.7%).
Conclusions: PERT dose requirements vary substantially by PEI aetiology, supporting aetiology-aware starting doses, early reassessment, and individualised optimisation in high-risk groups.