Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis

J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.


Background: Zenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).

Methods: 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).

Results: 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.

Conclusions: Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.

Keywords: Clinical trial; Cystic fibrosis; Enzepi; Exocrine pancreatic insufficiency (EPI); Pancreatic enzyme product (PEP); Zenpep.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Cystic Fibrosis* / complications
  • Cystic Fibrosis* / diagnosis
  • Cystic Fibrosis* / physiopathology
  • Cystic Fibrosis* / therapy
  • Double-Blind Method
  • Drug Monitoring
  • Enzyme Replacement Therapy / methods*
  • Exocrine Pancreatic Insufficiency* / diagnosis
  • Exocrine Pancreatic Insufficiency* / etiology
  • Exocrine Pancreatic Insufficiency* / therapy
  • Female
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Intestinal Absorption / drug effects
  • Male
  • Pancreas / enzymology*
  • Pancreatic Function Tests / methods
  • Pancrelipase* / administration & dosage
  • Pancrelipase* / adverse effects
  • Treatment Outcome


  • Gastrointestinal Agents
  • Pancrelipase

Associated data