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Clinical data in exocrine pancreatic insufficiency (EPI)
497 Study†: A double-blind, placebo-controlled crossover treatment period with a follow-up safety period was used to evaluate safety, tolerability, and fat absorption with RELiZORB in patients with EPI due to CF.1,2
Changes in plasma concentrations of DHA and EPA1,3
DHA and EPA were used as measures in the studies as they are strongly correlated with overall fat absorption.
2.8-fold overall increase in total DHA and EPA vs placebo (AUC0-24h; P<0.001)2
Gastrointestinal (GI) Events1
GI events are expressed as: number of events (number of patients reporting events).
57% reduction in the incidence of diarrhea from Period A to Period C2,†
498 ASSURE Study: A 90-day, multicenter, open-label study, in which RELiZORB was used with overnight tube feeding, that evaluated the safety, tolerability, and improvement in fatty acid status in red blood cell (RBC) membranes in patients with EPI due to CF.4
Changes in Erythrocyte Membrane Fatty Acid Composition (%) for Omega-3 Index4
2.1-fold increase in RBC uptake of DHA and EPA relative to total fatty acid and erythrocyte membranes1,4
Sustained use of RELiZORB in 498 STUDY4
61% of participants demonstrated improvement in weight percentiles4,§
All exploratory efficacy outcomes, including serum levels of fat-soluble vitamins A, D, and E in plasma total protein, prealbumin, albumin, and transferrin, were within normal ranges at study entry and remained so throughout the 90-day study treatment period.4
*Use of RELiZORB was shown to normalize concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature.2,4
†497 Study consisted of 3 distinct periods. Period A lasted 7 days and was meant to establish a baseline while patients maintained their standard PERT dosing along with overnight tube feeding. Period B lasted 11 days (including a 7-day washout period before crossover) and evaluated the effect of RELiZORB use on fat absorption via DHA and EPA plasma measures. Period C lasted 7 days and evaluated the safety and tolerability of RELiZORB by comparing outcomes with Period A (baseline).1,2
‡P<0.001 for difference from baseline to Day 30, Day 60, and Day 90.4
§Overall, weight and BMI z-scores and percentiles were not significantly different from baseline to 90 days. However, 20/33 (61%) patients had improvement in weight z-scores and percentiles in the intention-to-treat (ITT) population.4
RELiZORB PRECLINICAL DATA IN EPI AND SBS PORCINE MODELS
Evaluated tolerability and fat absorption with use of RELiZORB during a single tube feeding.
Evaluated tolerability and fat absorption with use of RELiZORB following 12 consecutive nightly tube feedings.
DHA & EPA plasma concentrations following use of RELiZORB during a single TUBE feeding1,||
RELiZORB demonstrated1:
The clinical significance of these findings has not been determined.1
Evaluated RELiZORB for improvement in fat and nutrient absorption with continuous tube feedings.
Evaluated use of RELiZORB in conjunction with bolus tube feedings in weaning parenteral nutrition (PN).
The decrease in PN calories coincided with an increase in enteral nutrition (EN) Advancement5,**
RELiZORB demonstrated5,6:
The clinical significance of these findings has not been determined.1
||Study conducted in a porcine model measured results of a single tube feeding (500 mL; 120 mL/hr) administered through RELiZORB over 24 hours compared to an identical tube feeding that was not administered through RELiZORB.1
¶Parallel group study conducted in a porcine model measured results of nightly tube feedings (750 cal) administered over 12 consecutive days with (n=6) and without (n=5) use of RELiZORB.1
**Parallel study conducted in a porcine model consisting of 2 groups: 75% intestinal resection (n=6) and 75% resection plus RELiZORB (n=5). PN was initiated post-operatively and was decreased as EN was advanced. EN was delivered daily via 6 bolus feeds with or without RELiZORB for 14 days.1
††No statistically significant difference in CFA between resected animals receiving RELiZORB and unresected animals in control (87.1% vs 95.2%, p=0.19).1
‡‡In the preclinical study, intestinal length increased on average by 68.4 ± 19.1 cm (19.5 ± 5.5%) compared with 0.8 ± 18.3 cm (0.7 ± 5.2%) in the control group (P=0.03).5
RELiZORB is proven to hydrolyze available fats, including medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs).1,7
Please see list of compatible formulas.
DHA=docosahexaenoic acid; EPA=eicosapentaenoic acid; LS=least-square.
References: 1. RELiZORB. Instructions for use. Alcresta Therapeutics, Inc; 2023. 2. Freedman S, Orenstein D, Black P, et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2017;65(1):97-101. doi:10.1097/MPG.0000000000001617 3. Harris WS, Sands SA, Windsor SL, et al. Omega-3 fatty acids in cardiac biopsies from heart transplantation patients: correlation with erythrocytes and response to supplementation. Circulation. 2004;110(12):1645-1649. doi:10.1161/01.CIR.0000142292.10048.B2 4. Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and safety with sustained use of RELiZORB evaluation (ASSURE) study in patients with cystic fibrosis receiving enteral feeding. J Pediatr Gastroenterol Nutr. 2018;67(4):527-532. doi:10.1097/MPG.0000000000002110 5. Tsikis ST, Fligor SC, Hirsch TI, et al. A digestive cartridge reduces parenteral nutrition dependence and increases bowel growth in a piglet short bowel model. Ann Surg. 2023;278(4):e876-e884. doi:10.1097/SLA.0000000000005839 6. Tsikis ST, Fligor SC, Secor JD, et al. An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome. Clin Nutr. 2022;41(5):1093-1101. doi:10.1016/j.clnu.2022.03.026 7. Shah ND, Limketkai BN. The use of medium-chain triglycerides in gastrointestinal disorders. Practical Gastroenterol. 2017;41(2):20-28.
Review full product information for RELiZORB in the Instructions for Use.