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.
The primary efficacy endpoint was the coefficient of fat absorption over 72h (CFA-72h).
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.
Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI.