CFDB - Cystic Fibrosis DataBase

primary studies published RCT

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

Study design (if review, criteria of inclusion for studies)

Randomised, double-blind, crossover, multinational, multicentre non-inferiority study


96 Patients on a standardised diet and stabilised treatment (mean age 19.2years, 60.4% males)


Zenpep and Kreon, both containing 25,000 lipase units, were compared. Patients on a standardised diet and stabilised treatment were randomised to two treatment sequences: Zenpep/Kreon or Kreon/Zenpep.

Outcome measures

The primary efficacy endpoint was the coefficient of fat absorption over 72h (CFA-72h).

Main results

83 patients completed 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.

Authors' conclusions

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

Keywords: Adolescent; Adult; Child; Enteric-Coated; Gastrointestinal Diseases; Malabsorption; pharmacological_intervention; Nutrition Disorders; Pancreas insufficiency; Pancreatic Diseases; Pancreatic Enzyme Replacement Therapy; EUR-1008; Gastrointestinal Agents; Creon;