Efficacy of pancrease: crossover comparative study versus eurobiol in cystic fibrosis.
An open crossover study in patients with documented cystic fibrosis (CF) compared the efficacy and acceptability of Pancrease (Cilag, PC), consisting of pH-sensitive, enteric-coated microspheres, with those of Eurobiol, consisting of lyophilized total pancreas. Eleven patients, age 6-17 years, were hospitalized for study. A hypercaloric, normal fat diet as well as previous antibiotic, vitamin, and other CF therapy were maintained during the 2-week study period. During the first study week, eight patients were given four divided doses of either Pancrease, 8 capsules daily, and two patients were given Eurobiol, 2 bottles daily. One patient received six Pancrease capsules or 1.5 bottles of Eurobiol daily. Patients were switched to the alternate drug for the second study week. Stools were collected for analysis over the final 3 days of each week. Steatorrhea (mean +/- 1 SD) with Pancrease was 11.8 +/- 6.6 g/24 h and with Eurobiol was 17.9 +/- 11.7 g/24 h. The coefficient of lipid absorption was 74.1 +/- 13.3% for Pancrease and 58.6 +/- 22.5% for Eurobiol (p less than 0.02). The decrease in steatorrhea and increase in lipid absorption with Pancrease compared to Eurobiol were 33.9% and 26.5%, respectively. All patients considered the acceptability of Pancrease superior to that of Eurobiol. No adverse effects were seen with either drug.
D000293:Adolescent; D001682:Biological Availability; D002446:Celiac Disease / Q000188:drug therapy / Q000378:metabolism; D002648:Child; D002986:Clinical Trials as Topic; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007408:Intestinal Absorption; D008049:Lipase / Q000493:pharmacokinetics / Q000627:therapeutic use*; D050356:Lipid Metabolism; D008297:Male; D008863:Microspheres; D010184:Pancreatic Extracts / Q000493:pharmacokinetics / Q000627:therapeutic use*; D020799:Pancrelipase
C056841:Eurobiol; D010184:Pancreatic Extracts; D020799:Pancrelipase; D008049:Lipase