COMPARISON OF WEIGHT-BASED DOSAGES OF ENTERIC-COATED MICROTABLET ENZYME PREPARATIONS IN PATIENTS WITH CYSTIC-FIBROSIS

Twenty-one stable hospitalized cystic fibrosis patients with malabsorption syndrome participated in an open-label crossover clinical trial to evaluate the efficacy of two-period dosing regimens of a pancreatic microtablet enzyme preparation in the treatment of steatorrhea. Standard dosing consisted of 500 U lipase/kg body weight/ meal, 250 U lipase/kg body weight/snack; high dosing consisted of 1,500 U lipase/kg body weight/meal, 750 U lipase/kg body weight/snack. Doses were determined by units of lipase/kg body weight to provide dosing consistency among patients of varying size. Each patient was on a regular diet of similar to 100 g of fat per day. Two separate, 72-h stool collections were performed between markers. A significant difference in mean percentage fat absorbed between the standard dose and the high dose was found (86% versus 91%, p < 0.05). Subjects were then stratified into two groups, based on the grams of fecal fat eliminated (GFFE) as follows: Group 1 with less than or equal to 7 GFFE/24 h on both dosages (n = 7) and Group 2 with >7 GFFE/24 h on either dose (n = 14). A significant difference (p < 0.05) between Group 1 (96%) and Group 2 (88%) was noted in the percentage fat absorbed while on the high dose. Fat absorption improved from 81% to 88%, (p < 0.05) in Group 2. During the study period, the adverse reactions of constipation or elevated serum uric acid levels were not observed. The increased doses of pancreatic enzymes resulted in improved correction of steatorrhea.