Comparison between a standard pancreatic supplement and a high enzyme preparation in cystic fibrosis

Abstract

This study compared the relative effectiveness of a standard pancreatic enzyme supplement (' Creon ', Duphar) and a new preparation ('Pancrease HL', Cilag) containing about 3 times the lipase and more than 5 times the protease activity. Capsule dosage was adjusted to a ratio of approximately 3 : 1. Fat balances showed that absorption of fat did not change significantly on conversion to the new high-lipase product, and the coefficient of absorption of total energy was similarly maintained. The coefficient of protein absorption was significantly enhanced with the high enzyme preparation ( P < 0.01), which may explain the reported subjective improvement in stool odour. No adverse effects were recorded. Patient acceptability of the new compound was high; the great reduction in the number of capsules required at each meal was cited by all patients as the reason for their preference.

EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency

“…There were no drug-related SAEs or discontinuations, nor were there any incidences of hyperuricemia or unexpected adverse trends in laboratory analyses following treatment with EUR-1008. As with previous studies of PEPs in young children [22][23][24][25][26], no age-related issues were noted with EUR-1008. However, these safety data may be limited by the short length of the study period (two weeks), which is too brief to detect AEs such as fibrosing colonopathy (not observed in this study).…”

“…This is significant, as weight loss during infancy or childhood correlates with poor adult pulmonary status in CF patients [5][6][7][8][9][10][11]. The decision to not use a placebo treatment or washout period in the design of the supplemental study is consistent with the practice reported in other published trials involving young CF patients [22][23][24][25][26].…”

“…Guidelines from the FDA now require that new PEPs be formulated to meet the label-claimed enzyme content and demonstrate safety and efficacy in human clinical trials [21], including trials in young children. Although there appear to be no age-related issues with PEP treatment in children b7 years of age [22][23][24][25][26], little safety data has been published in this patient group. The majority of literature on PEP usage in cystic fibrosis has focused on adolescents and adults.…”

Personalizing protein nourishment

“…Enzyme supplements effectively increase digestion (primarily of lipids, as steatorrhea is a major problem) and decrease malabsorption (Valerio et al, 1981). Increasing the dose of proteases in these supplements enhanced protein absorption in patients with chronic pancreatitis (Morrison et al, 1992). More research is needed to determine the effectiveness of enzyme supplementation treatments to enhance protein digestion in patients with chronic pancreatitis.…”

Systematic review: efficacy and safety of pancreatic enzyme supplements for exocrine pancreatic insufficiency

“…Twenty‐nine relevant studies were identified, retrieved and completely reviewed. Seventeen studies 6–22 did not meet study selection criteria because of a variety of exclusion criteria, including inappropriate or incomplete reporting about changes in fat absorption, non‐use of cross‐over design, or use of inappropriate patient populations. Twelve studies 23–34 met all inclusion criteria and were available in full manuscript form for inclusion in this systematic review (Table 1).…”