title: Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA. toskepp@medicine.ufl.ed
authors.forename: Phillip P
authors.initials: PP
authors.lastname: Toskes
authors.forename: Angelo
authors.initials: A
authors.lastname: Secci
authors.forename: Ruth
authors.initials: R
authors.lastname: Thieroff-Ekerdt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000032:analysis / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D050500:Pancreatitis, Chronic / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D020799:Pancrelipase / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004041:Dietary Fats; D020799:Pancrelipase