Drug updated on 11/1/2024
Dosage Form | Capsule (oral; lipase/protease/amylase [3,000 USP/9,500 USP/15,000 USP], [6,000 USP/19,000 USP/30,000 USP], [120,000 USP/38,000 USP/60, 000 USP], [24,000 USP, 76,000 USP, 120,000 USP], [36,000 USP, 114,000 USP, 180,000 USP]) |
Drug Class | Digestive enzymes |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- In patients with exocrine pancreatic insufficiency (EPI), including those with chronic pancreatitis, pancrelipase (Creon®) was associated with increased Coefficient of Fat Absorption (CFA) levels, showing an improvement range from a 7.5% increase in placebo recipients to a 36% increase in those treated with Creon®.
- Pancrelipase, including Creon®, also improved the Coefficient of Nitrogen Absorption (CNA) in EPI patients compared to placebo, with no significant differences in CNA-72h observed between Creon® (82.0% [SE: 1.2]) and Zenpep® (80.9% [SE: 1.2]) in a head-to-head study.
- Treatment with PERT generally led to increases in body weight (0.1 to 6.1 kg) and BMI or reduced their decline, benefiting EPI patients with weight loss or low BMI.
- Pancreatic enzyme replacement therapy (PERT), including Creon®, was generally reported as safe and well-tolerated across 18 studies, with no specific safety concerns or adverse effects highlighted for particular population types or subgroups.
- The systematic review focused on patients with exocrine pancreatic insufficiency (EPI) due to conditions like cystic fibrosis and chronic pancreatitis, finding that treatment with Creon® significantly improved the coefficient of fat absorption (CFA) and nitrogen absorption (CNA), as well as body weight and BMI, which is particularly relevant for EPI patients experiencing malabsorption and weight loss.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Creon (pancrelipase) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinical Efficacy and Safety of Treatments for Exocrine Pancreatic Insufficiency: A Systematic Literature Review | 2024 | Digestion |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Evidence-based clinical practice guidelines for chronic pancreatitis 2021. | 2022 | Journal of Gastroenterology |