Efficacy

Help fuel your patients' nutritional health with significant improvement in CFA vs placebo1

For the treatment of EPI due to CF or other conditions ZENPEP helps fuel nutritional health, increasing coefficient of fat absorption (CFA) by 26 percentage points vs placebo1

PRIMARY ENDPOINT: MEAN DIFFERENCE IN CFA1,2*

*
A randomized, double-blind, placebo-controlled, 2-treatment, crossover study (ZENPEP Study 1) in patients with EPI due to CF aged 7 to 23 years. Patients were randomized to ZENPEP or placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for 6 to 7 days. All patients consumed ≥ 100 g fat per day. The primary efficacy endpoint was the mean difference in CFA between ZENPEP and placebo, which was measured from a 72-hour stool collection during both treatments. The use of enzymes other than ZENPEP and drugs affecting gastric pH or motility were not allowed during the trial.1,2
One patient did not have fecal fat and nitrogen readings while on placebo.2

In a non-inferiority study, ZENPEP was shown to have comparable efficacy to Creon®3

ZENPEP demonstrated both non-inferiority and equivalence to Creon in dietary fat absorption (ZENPEP 84.1% vs Creon 85.3%; difference in LS means: –1.3% [95% CI, –3.6 to 1.1] P=0.297)

A randomized, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged ≥12 years. Patients enrolled with an established PEP regimen and then a 100 g (± 15 g) fat/day diet was assigned and maintained throughout the study. Patients were randomized to 2 treatment sequences of 28 days each: ZENPEP/Creon or Creon/ZENPEP. The primary efficacy endpoint was CFA over 72 hours (CFA-72 hours).3

ZENPEP significantly improved CFA in patients with EPI due to CF2

  • In clinical trials, patients did not use agents that affect gastric motility or stomach pH

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    PPIs, H2 blockers, motility agents, buffering agents, laxatives, agents for gastric ulcers, and synthetic fat substitutes or fat-blocking nutritional supplements

EPI=exocrine pancreatic insufficiency; CF=cystic fibrosis; CFA=coefficient of fat absorption; PEP=pancreatic enzyme product; PPI=proton pump inhibitor.

Safety Profile