Pancrelipase Improves Stool Frequency and Consistency in EPI

Among patients with exocrine pancreatic insufficiency (EPI), use of pancrelipase significantly improved stool frequency and consistency after 1 week compared with placebo, according to study results presented at the American College of Gastroenterology (ACG) 2022 Annual Meeting, held from October 21 to 26, 2022, in Charlotte, North Carolina, and virtually.

Researchers evaluated the effect of pancreatic enzyme replacement therapy (PERT) on EPI symptoms in a posthoc analysis of a double-blind, randomized, phase 3 trial in patients with EPI resulting from chronic pancreatitis (CP) or pancreatic surgery (PS).

The participants had a 5-day placebo run-in period and then were randomly assigned to pancrelipase (72,000 LU/meal; 36,000 LU/snack) or placebo for a 7-day, double-blind period. Patients completed a daily diary regarding stool frequency (number of stools), stool consistency (-1=hard; 0=formed/normal; 1=soft; 2=watery), flatulence, and abdominal pain (0=none; 1=mild; 2=moderate; 3=severe).

The study authors calculated the average daily reported symptoms in each period and determined the mean results for each treatment group.

A total of 52 patients (24 received pancrelipase; 28 received placebo) were included (75% had CP; 25% had PS) in the study. The mean age was 51.7 years in the pancrelipase group (men, 75%) and 50.4 years in the placebo group (men, 68%).

Participants who received pancrelipase had a mean reduction of 1.2 stools/day (95% CI, -2.284 to -0.128) compared with those who received placebo (P =.0296). Those who received pancrelipase also had a mean change in stool consistency score of 0.369 (95% CI, -0.623 to -0.115) vs placebo (P =.0052). A shift analysis of change in stool consistency from the run-in period to the double-blind period for the pancrelipase group compared with the placebo group showed improvement in 33% vs 7%; no change in 67% vs 82%; and worsening in 0% vs 11%, respectively.

Among patients with formed/normal stools, the absolute percentage change was 33% greater for those who received pancrelipase vs those who received placebo (P =.0033) from the run-in period to the double-blind period. Pancrelipase also eliminated watery stools. A trend was observed toward improvement in flatulence and abdominal pain for the pancrelipase group vs the placebo group.

“Patient-reported stool frequency and consistency could be used with nutritional markers to assess clinical efficacy of PERT for treatment of EPI due to CP or PS,” the study authors wrote.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.