Efficacy

ZENPEP® helped patients absorb the fats, proteins, and vitamins needed from their meals1,2

Mean Difference in CFA and CNA1,2*

Efficacy graphicEfficacy graphic

  • ZENPEP demonstrated results without the use of PPIs, H2-blockers, or motility agents in clinical studies 2

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; PPI=proton pump inhibitor.

* 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 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 was not allowed during the trial.1,2

†One patient did not have fecal fat and nitrogen readings while on placebo.2

91% of patients achieved a CFA of 80% or higher with ZENPEP2

  • 50% achieved a near-normal CFA above 90%2‡
  • Vitamin A and E absorption significantly improved with ZENPEP vs placebo (P<0.001)

‡Normal CFA is defined as >93% by the American College of Gastroenterology.3

ZENPEP provided relief for a range of symptoms2

Decreased EPI symptoms can help patients eat with less discomfort4

Significant reduction in EPI-related GI symptoms with ZENPEP vs placebo 2§

Symptom ReliefSymptom Relief

GI=gastrointestinal.

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

Statistically significant improvement in mean Total Symptoms Index (TSI) score|| was demonstrated with ZENPEP vs placebo (P=0.015).5

||TSI assesses overall improvement in the clinical symptoms of EPI.
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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. Gardner TB, Adler DG, Forsmark CE, Sauer BG, Taylor JR, Whitcomb DC. ACG Clinical Guideline: chronic pancreatitis. Am J Gastroenterol. 2020;115(3):322-339. doi:10.14309/ajg.0000000000000535 4. Othman MO, Harb D, Barkin JA. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72(2):e13066. doi:10.1111/ijcp.13066 5. Data on File. CSR-1008. Nestlé Health Science.