In a clinical study, use of RELiZORB was shown to normalize plasma concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature (please see IFU for full description of the study and references).
Changes in plasma concentrations of DHA and EPA (omega-3 fatty acids)
Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) absorption results with RELiZORB were consistent across all age groups studied (AUC0-24h)
DHA and EPA were used as measures in the study as they are strongly correlated with overall fat absorption and with levels incorporated in membranes1
Study Design: Multicenter, prospective, randomized, double-blind, placebo-controlled, cross-over study conducted in 33 patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). Patients were ages 5 to 34 with CF-associated EPI, receiving supplemental enteral nutrition (EN).
overall increase in total DHA and EPA with RELiZORB versus placebo (AUC0-24h; P<0.001)
>50% Reported a Decrease in the Frequency of Some GI Events2
Number of GI events among 33 pediatric and adult patients with cystic fibrosis*
Overall, the frequency of GI events decreased in Period C compared with Period A
During period C of the trial, 42% (n=14) of patients using RELiZORB stopped taking PERT capsules
Despite protocol instructions to maintain their usual practice
Gastrointestinal events are expressed as: number of events (number of patients reporting events).
Period A=baseline run-in period. Period C=open-label safety period.
AUC=area under the curve. GI=gastrointestinal. PERT=pancreatic enzyme replacement therapy.
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;110:1645-1649.
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 Pediatric Gastroenterol Nutr. 2017;65(1):97-101.