title: Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis.
abstract: Zenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
  
  
  
  Zenpep and Kreon, both containing 25,000 lipase units, were compared in a randomised, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged ≥12years. Patients on a standardised diet and stabilised treatment were randomised to two treatment sequences: Zenpep/Kreon or Kreon/Zenpep. The primary efficacy endpoint was the coefficient of fat absorption over 72h (CFA-72h).
  
  
  
  96 patients (mean age 19.2years, 60.4% males) were randomised with 83 completers of both sequences comprising the efficacy population. Zenpep demonstrated non-inferiority and equivalence to Kreon in fat absorption (LS mean CFA-72h: Zenpep, 84.1% [SE 1.1] vs. Kreon, 85.3% [SE 1.1]; p=0.297). Safety and tolerability were similar.
  
  
  
  Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.
authors.affiliation: University of Sheffield, Sheffield, UK. Electronic address: c.j.taylor1@sheffield.ac.uk.
authors.forename: C J
authors.initials: CJ
authors.lastname: Taylor
authors.affiliation: Former employee of Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA. Electronic address: rekerdt@cortendo.com.
authors.forename: R
authors.initials: R
authors.lastname: Thieroff-Ekerdt
authors.affiliation: Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA. Electronic address: steven.shiff@frx.com.
authors.forename: S
authors.initials: S
authors.lastname: Shiff
authors.affiliation: Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA. Electronic address: leslie.magnus@frx.com.
authors.forename: L
authors.initials: L
authors.lastname: Magnus
authors.affiliation: Former employee of Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA. Electronic address: rosabfleming@yahoo.com.
authors.forename: R
authors.initials: R
authors.lastname: Fleming
authors.affiliation: Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA. Electronic address: carl.gommoll@frx.com.
authors.forename: C
authors.initials: C
authors.lastname: Gommoll
mesh_terms: D000293:Adolescent; D000328:Adult; D003550:Cystic Fibrosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D004311:Double-Blind Method; D016903:Drug Monitoring; D056947:Enzyme Replacement Therapy / Q000379:methods*; D010188:Exocrine Pancreatic Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D008297:Male; D010179:Pancreas / Q000201:enzymology*; D010186:Pancreatic Function Tests / Q000379:methods; D020799:Pancrelipase / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D020799:Pancrelipase
keywords: Clinical trial; Cystic fibrosis; Enzepi; Exocrine pancreatic insufficiency (EPI); Pancreatic enzyme product (PEP); Zenpep