NEW YORK (Reuters Health) Pancrelipase (pancreatin) delayed-release capsules (CREON, Solvay Pharmaceuticals) increase fat and protein absorption in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery, according to results of a small randomized trial.

The double-blind, multicenter study showed that, after 7 days, CREON increased the coefficient of fat absorption and the coefficient of nitrogen absorption by almost four-fold compared with placebo. Active treatment also improved stool consistency and flatulence, the authors reported online May 25 in the American Journal of Gastroenterology.

After a 5-day placebo run-in, Dr. David C. Whitcomb from the University of Pittsburgh, Pennsylvania and colleagues randomized 25 patients to pancrelipase (11355,000 lipase units per meal; 36,000 per snack) and 29 to placebo for 7 days. All patients (median age 54 years, 76% male) also received a diet providing at least 100 g of fat per day. Subjects spent the duration of the trial either in hospitals or clinical research centers.

The mean change from baseline in coefficient of fat absorption (calculated from fat intake and excretion) was 32.1% in the pancrelipase group vs 8.8% in the placebo group (p < 0.0001). Corresponding changes in coefficient of nitrogen absorption were 97.7% and 24.4% (p = 0.0013).

Compared to placebo patients, subjects who received pancrelipase were significantly more likely to have formed/normal stools at the end of the trial (p = 0.006) and to have no flatulence (p = 0.031).

Five patients in the pancrelipase group and six in the placebo group reported at least one treatment-emergent adverse event, primarily GI events and metabolism and nutritional disorders. There were no meaningful differences in laboratory parameters or in vital signs.

The good safety profile of pancrelipase provides a particularly favorable benefit to risk ratio, the authors write.

They point out that around two-thirds of patients with exocrine pancreatic insufficiency due to chronic pancreatitis have low nutritional parameters even when their symptoms are under control with pancreatic-enzyme replacement therapy. They recommend using sensitive measures of nutritional status to optimize pancreatic enzyme replacement and nutrition.

As the (coefficient of fat absorption) test does not discriminate between hepatobiliary, mucosal, and pancreatic causes of fat malabsorption, detailed pancreatic imaging and concomitant functional diagnosis in these patients remains essential, they add.

Reference:
http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2010201a.html
Am J Gastroenterol 2010.