Enzyme Replacement Therapy of Exocrine Pancreatic Insufficiency in Man

Abstract

I assayed 16 commercially available pancreatic extracts (representing capsules, tablets and enteric-coated tablets) for enzyme activities and the relation between the in vitro activities and in vivo potency evaluated in man. Lipase activity ranged from 10 to 3600 units per unit, with 11 preparations containing less than 600 units per unit. The preparations with the highest lipase activities were llozyme, 3600, Kuzyme HP, 2330, Festal, 2073, Cotazym, 2014, and Viokase, 1636 units. Lipase activity in vitro correlated with potency in vivo for tablets and capsules, with tablets and capsules being effective in reducing steatorrhea by 56.1±9 per cent and 48.6±10 per cent (mean ±S.E.M.) respectively, P0.02). The longer the gastric pH remained ≥4 (r = 0.915, P<0.01) and the higher the average duodenal pH (r = 0.966, P<0.01), the more marked the reduction in steatorrhea. (N Engl J Med 296:1314–1317, 1977)