This double-blind, randomized, multicountry, placebo-controlled trial assessed the safety and efficacy of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules (CREON) in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units per meal; 36,000 per snack) or placebo for 7 days. All patients received an individually designed diet to provide at least 100g of fat per day. The primary efficacy measure was the change in coefficient of fat absorption (CFA) from baseline to end of the double-blind period. In total, 25 patients (median age of 54 years, 76% male) received pancrelipase and 29 patients (median age of 50 years, 69% male) received placebo. The mean±s.d. change from baseline in CFA was significantly greater with pancrelipase vs. placebo: 32.1±18.5% vs. 8.8±12.5% (P<0.0001). Similarly, the mean±s.d. change from baseline in coefficient of nitrogen absorption (CAN) was greater for pancrelipase vs. placebo: 97.7±82.3% vs. 24.4±101.0% (P=0.0013). Greater improvements from baseline in stool frequency, stool consistency, abdominal pain, and flatulence were observed with pancrelipase vs. placebo. (Am J Gastroenterol. 2010 Oct;105(10):2276-86. Epub 2010 May 25.) PMID: 20502447.
