Comparative trial of Viokase®, pancreatin and Pancrease® pancrelipase (enteric coated beads) in the treatment of malabsorption in cystic fibrosis

Abstract

ABSTRACT. Pancreatic extracts, even in high doses, usually fail to completely control steatorrhoea in cystic fibrosis (CF), due to inactivation of the enzymes by acid and pepsin. Pancrease is a new formulation consisting of pH-sensitive, enteric coated beads which protect the pancreatic enzymes from acid and pepsin denaturation. Twelve patients with CF entered an outpatient study to examine the effectiveness of this product compared with that of a conventional product (Viokase®). Two doses for each product were used during four sequential 4-week periods. Twenty-two capsules of Pancrease® daily was significantly better than 32 capsules of Viokase® daily (faecal fat excretion 8.7 ± 4.1 g/day, 17.3 ± 9.1 g/day, p < 0.01; coefficient of absorption 89.5 ± 4.2%, 79.3 ± 9.9%, p < 0.01; bowel actions/day 1.7 ± 0.7, 2.2 ± 0.9, p < 0.05; rank scores of stool odour and stool consistency, both p < 0.05; parent's treatment preference p < 0.01). No difference was detected between Viokase® 32 capsules daily and Pancrease® 11 capsules daily, but both were significantly better than 16 capsules of Viokase® daily.