Efficacy
ZENPEP® helped patients absorb the fats, proteins, and vitamins needed from their meals1,2
Mean Difference in CFA and CNA1,2 *
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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§
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
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.
