Journal article
Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis
Pancreas, Vol.40(3), pp.376-382
04/2011
DOI: 10.1097/MPA.0b013e31820b971c
PMID: 21343835
Abstract
EUR-1008 (ZENPEP® [pancrelipase] Delayed-Release Capsules) delayed-release capsules is a novel, enteric-coated, porcine-derived pancreatic enzyme product. This study evaluated the efficacy and safety of 2 doses of ZENPEP in patients with chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI).
The effect of ZENPEP on the coefficient of fat absorption (CFA) was investigated in a randomized, double-blind, dose-response, crossover study with placebo run-in (7-9 days) and 2 treatment periods (9-11 days) composed of a high dose (7 × 20,000 lipase units per day) and a low dose (7 × 5000 lipase units per day).
Mean CFA was significantly higher with low- (88.9%) and high-dose (89.9%) ZENPEP versus placebo run-in (82%; P < 0.001; n = 72) with no difference between doses (P = 0.228, primary end point). In patients with baseline CFA less than 90% (n = 33), the high dose was significantly more effective (CFA: 84.1%) than the low dose (CFA: 81.1%; P < 0.001). Post hoc analysis revealed an increase in treatment effect with more severe EPI. Coefficient of nitrogen absorption (P < 0.001), body weight (P ≤ 0.021), and body mass index (P ≤ 0.020) also increased significantly with both doses compared with baseline. Percentage of days with EPI symptoms decreased with both doses.
Our findings suggest that CP patients with EPI benefit from a low dose of ZENPEP, whereas the high dose might be needed for patients with more severe EPI.
Details
- Title: Subtitle
- Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis
- Creators
- Phillip P Toskes - Department of Medicine, University of Florida, Gainesville, FL, USA. toskepp@medicine.ufl.edAngelo SecciRuth Thieroff-EkerdtZENPEP Study Group
- Contributors
- Frederick Johlin (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Pancreas, Vol.40(3), pp.376-382
- DOI
- 10.1097/MPA.0b013e31820b971c
- PMID
- 21343835
- ISSN
- 0885-3177
- eISSN
- 1536-4828
- Grant note
- 1UL1RR029890 / NCRR NIH HHS UL1 RR029890 / NCRR NIH HHS
- Language
- English
- Date published
- 04/2011
- Academic Unit
- Gastroenterology and Hepatology; Internal Medicine
- Record Identifier
- 9984094402402771
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