COMPARATIVE-EVALUATION OF A HIGH LIPASE PANCREATIC-ENZYME PREPARATIONAND A STANDARD PANCREATIC SUPPLEMENT FOR TREATING EXOCRINE PANCREATICINSUFFICIENCY IN CHRONIC-PANCREATITIS

Objective: To compare the efficacy and safety of two enzyme-containing preparations, Pancrease Ht (Cilag) containing 25 000 units of lipase per capsule and Creon (Triosol) with 8000 units of lipase per capsule, in patients with chronic pancreatitis and exocrine insufficiency. Des ign: The study is a monocentric open crossover prospective study inclu ding 25 patients entered from March 1993 to May 1994. Patients: Chroni c pancreatitis was alcohol-related in 23 patients, previous surgery wa s performed in 9, 16 had diabetes and all had steatorrhoea (fat balanc e > 10g/24 h). Methods: Patients were investigated during four periods of 2 weeks, each one corresponding to a new treatment regimen: Pancre ase HL, 3 capsules/day or Creon, 9 capsules/day, with or without omepr azole 20 mg/day. Stools were collected on the last 3 days at the end o f each period when the patients were on a standard diet with a fixed d aily intake of 100g fat/day. Results: Faecal fat, protein and energy e xcretion did not differ when both preparations were compared at roughl y pharmaceutically equivalent doses. No significant improvement in fat and protein absorption was observed when omeprazole was taken with th e pancreatic enzymes. However, omeprazole treatment was associated wit h a marked decrease in the fat-protein content ratio, suggesting an im provement in the fat digestive process but a decrease in the efficienc y of protein digestion. Drug safety was comparable in the four groups of treatment. Conclusion: Pancrease HL with high lipase activity provi des effective pancreatic enzyme replacement therapy in patients with c hronic pancreatitis at an appreciably lower number of capsules per day than with standard preparations.