S64 Clinical Efficacy and Safety of Treatments for Exocrine Pancreatic Insufficiency: A Systematic Literature Review
Bibliographic record
Abstract
Introduction: Exocrine pancreatic insufficiency (EPI) is caused by multiple clinical conditions such as cystic fibrosis (CF) and chronic pancreatitis. Standard management of EPI includes Pancreatic Enzyme Replacement Therapy (PERT) along with consultation with a dietitian. While PERT has been on the market for several decades, newer publications on the clinical efficacy and safety of PERT necessitated a comprehensive update of the literature. We aimed to identify the available evidence on the clinical efficacy and safety of treatments for EPI to understand the current treatment landscape. Methods: A systematic literature review was conducted in Embase, Medline, and Evidence-Based Medicine databases from 2010–2022; conference proceedings from 2020–2022 were also searched. Articles were screened independently by 2 reviewers at abstract and full text stage against pre-defined eligibility criteria. Results: We identified 26 journal publications and 2 conference abstracts, reporting on 22 randomized control trials, 4 observational studies and 2 single arm interventional studies. The most reported investigational treatment was pancrelipase, specifically Creo (n=12). Thirteen studies reported coefficient of fat absorption (CFA) results. Across studies, patients experienced an increase in CFA post initiation of treatment regardless of intervention or timepoint. Mean change in CFA ranged from 7.5% in patients with CP who received placebo to 36% in patients with CP treated with Creon®. Nine studies reported coefficient of nitrogen absorption (CNA). Mean change in CNA ranged from 3.7% in patients with CP receiving placebo to 39.1% in patients with CP treated with Creon®. When compared to placebo, pancrelipase increased CNA levels. Only one study compared PERT brands head-to-head; however, no significant differences were reported in the CNA-72 h values (Creon® 82.0% [SE1.2] vs Zenpep® 80.9% [SE 1.2]). Twelve studies reported body weight and body mass index (BMI); overall, treatment with PERT increased BMI and body weight or limited their decline. Creon increased BMI and body weight, with increases ranging from 0.1 to 6.1kg. Eighteen studies reported safety outcomes; overall, PERT was considered safe and well tolerated. Conclusion: This review confirmed that PERT is an effective and tolerable treatment option in patients with EPI. In the available evidence there was limited evidence for nutritional parameters and health-related quality of life.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.050 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.009 |
| Bibliometrics | 0.012 | 0.013 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".