I~P EkTHOPHYSIOI )GY ELSEVIER Pathophysiology 2 (1995) 247-250 Enteric-coated pancreatic enzyme supplementation. A dose-response study F. Marotta *, A.H. Girdwood, I.N. Marks, S.J.D. O'Keefe, G.O. Young Gastrointestinal Clinic, Departmentof Medicine, GrooteSchuur Hospital, Universityof Cape-Town, Cape-Town, South Africa Received 6 February 1995; accepted 7 June 1995 Abstract Nine patients with pancreatic steatorrhoea were investigated to assess the effect of increasing dosages of the enteric-coated preparation, Pancrease, on fat absorption. Baseline studies of gastric acid output, 72-h faecal fat excretion and ~4C triolein breath test were performed. The latter was repeated on alternative days using 2, 4 and 8 capsules of an enteric-coated enzyme preparation (Pancrease). Twenty healthy subjects served as controls for the 14C triolein breath test. Stool fat excretion showed that all but one of the patients had severe steatorrhoea (mean 191 + 15 mmol/day). The mean baseline 14C triolein breath test was 1.14 + 0.95%/h and significantly lower I P < 0.001) than the lower limit in controls (3.5%). A significant linear correlation (r = 0.67, P < 0.05) was shown between the breath lest and stool excretion. The mean percentage improvement in fat absorption as measured by 14C triolein breath test after 2, 4 and 8 capsules of Pancrease was 226 + 221%, 317 + 237% and 336 + 223%, respectively. Fat absorption was significantly improved by all lhree regimens. The 4- and 8-capsule schedule was significantly better than the 2-capsule one, but the 8-capsule dose was not better than Ihe 4. The improvement in fat absorption in more than half the patients was insufficient to achieve a normal breath test. The efficacy of lhe response to increasing dosages of Pancrease did not correlate with gastric acid output. Our results suggest that 4 capsules are as effective as 8 in improving the absorption of 25 g fat, which is the usual fat content of a normal diet. Keywords: Pancreatic enzyme replacement; Pancrease; Pancreatic steatorrhoea; Dose-response; 14C triolein breath test 1. Introduction Pancreatic replacement therapy remains the therapeutic cornerstone in the medical management of pancreatic steat- orrhoea. To abolish fat malabsorption, Di Magno et al. have shown that the amount and concentration of enzymes delivered into the duodenum must be 5-10% of the quan- tity normally present after maximal stimulation of the pancreas [1]. This is equivalent to the delivery into the duodenum of approximately 30000 IU of lipase during each meal. Unfortunately, conventional preparations of pancreatic extracts contain low concentrations of lipase per lablet and hence, large numbers of tablets must be taken with each meal. In addition, gastric acid may inactivate the ngested enzymes. This provides the rationale for the use of H2-receptor antagonists taken in conjunction with the pancreatic extracts. Another approach is to use pH-depen- ,tent enteric-coated microspheres which release the en- :,_ymes in the alkaline medium of the duodenum. * Corresponding author. Via Pisanello 4, 20146 Milan, Italy. I)928-4680/95/$09.50 © 1995 Elsevier Science B.V. All rights reserved SSD1 0928-4680(95)00034-8 The present study was carried out to assess the effect of increasing doses of enteric-coated microspheres (Pan- crease, Johnson and Johnson) on fat absorption in patients with alcohol-induced chronic pancreatitis. The adequacy of pancreatic replacement with the different dose levels was assessed by using the 14C triolein breath test, a simple and practical test which correlates well with the conventional but more tedious 3-day faecal fat collection [2]. 2. Methods 2.1. Patients The study group consisted of 9 adult males with a proven clinical diagnosis of alcohol-induced chronic pan- creatitis (Table 1). Eight patients had calcific pancreatitis. Eight were diabetics and, of these, four required insulin and four oral hypoglycemics. Seven patients were under- weight with markedly depleted fat stores as defined by triceps skin fold thickness below 60% of standard [3]. One