Efficacy

ZENPEP® can help your patients with CF absorb the fats, proteins, and vitamins from their food that they need with every meal1,2

Primary Endpoint: Mean Difference in CFA and CNA1,2*

Efficacy graphic Efficacy graphic Efficacy graphic

*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, followed by crossover to the alternate treatment for 6 to 7 days. All patients consumed ≥100 g of 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

Majority of patients achieved a near-normal CFA with ZENPEP: 91% of patients had a CFA above 80%2,3

  • Of these patients, 50% achieved a CFA above 90%

As the secondary endpoint of the clinical trial, ZENPEP showed a 22% improvement in mean CNA vs patients taking placebo (P<0.001; 95% CI, 16%-27%)

ZENPEP delivered relief for many EPI-related GI symptoms2‡

Graphic 67%

reduction in mild abdominal pain
(P<0.001)

Graphic 33%

reduction in stool frequency
(P<0.001)

Graphic 85%

fewer watery stools
(P=0.013)

Graphic 75%

reduction in moderate flatulence
(P<0.001)

Graphic 49%

reduction in soft stools
(P<0.001)

Graphic 76%

less oil and grease in stools
(P<0.001)

Percentages were derived from actual numbers in referenced data. P values were taken directly from reference.

CF=cystic fibrosis; CFA=coefficient of fat absorption; CI=confidence interval (the range in which we are 95% sure our mean value lies);
CNA=coefficient of nitrogen absorption; EPI=exocrine pancreatic insufficiency; GI=gastrointestinal.

Total Symptoms Index (TSI) score, which assessed overall improvement in the clinical symptoms of EPI, was significantly improved with ZENPEP vs placebo (P=0.015)4

References: 1. ZENPEP. Package insert. Nestlé Health Science; 2020. 2. Wooldridge JL, Heubi JE, Amaro-Galvez R, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009;8(6):405-417. doi:10.1016/j.jcf.2009.07.006 3. Borowitz D, Konstan MW, O'Rourke A, Cohen M, Hendeles L, Murray FT. Coefficients of fat and nitrogen absorption in healthy subjects and individuals with cystic fibrosis. J Pediatr Pharmacol Ther. 2007;12(1):47-52. doi:10.5863/1551-6776-12.1.47 4. Data on File. CSR-1008 Nestlé Health Science.