High dose Nutrizym 22 in cystic fibrosis

Abstract

New high dose pancreatic enzyme preparations could be potentially helpful to cystic fibrosis (CF) patients. The purpose of this study was to compare the efficacy of the new high dose pancreatic enzyme preparation, Nutrizym 22 with the standard preparation Nutrizym GR. Twenty-five CF children (aged 7-16 years) entered the study and 22 completed it; 3 did not, due to non-compliance. All were taking Nutrizym GR for at least 2 weeks before entering the study. A randomised double blind, crossover method using standard Nutrizym GR or double strength Nutrizym 22 capsules was carried out over two consecutive 14-day periods. Crossover analyses of variance showed no statistically significant differences in actual weight gain, appetite, abdominal pain, stool consistency or faecal fat during the prestudy and study periods. It is concluded that half the capsule numbers of the high strength preparation are just as effective as the standard capsule dosage.

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).…”

High‐ Versus Low‐Lipase Acid‐Resistant Enzyme Preparations in Cystic Fibrosis: A Crossover Randomized Clinical Trial

“…To date, there has been no definite demonstration that the two preparations are equivalent under the same lipase dosage. On an empirical basis, the dosage for high‐strength enzymes is about one‐third or half the number of capsules of the standard preparations (15‐17).…”

“…However, no study standardized the dosage of lipase in relation to the amount of fat ingested, timing of administration, fat intake, or pancreatin dosage. Since fat excretion or absorption was estimated by only 2‐day stool collection in two of them (16,20), there could be inevitable errors due to the interday variability of stool or fat excretion. In those studies, stool collection was carried out at home, without direct control by skilled personnel.…”

“…Only three previous studies have reported clinical use of a high‐lipase pancreatic enzyme preparation (15,16,20). However, no study standardized the dosage of lipase in relation to the amount of fat ingested, timing of administration, fat intake, or pancreatin dosage.…”