A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency.

Abstract

OBJECTIVE:

The safety and efficacy of Minimicrospheres, which are enteric-coated, delayed-release pancrelipase capsules, on fat absorption in pediatric/adolescent and adult cystic fibrosis (CF) patients was assessed. Exocrine pancreatic insufficiency, common in CF patients, causes steatorrhea due to insufficient release of pancreatic enzymes.

METHODS:

In the open-label phase, 97 CF patients with pancreatic insufficiency and steatorrhea were stabilized on a high-fat diet and administered pancrelipase. Seventy-four patients with >80% coefficient of fat absorption received placebo or pancrelipase in the double-blind phase. Fat intake and excretion, stool frequency and consistency, and clinical global improvement were recorded.

RESULTS:

Average daily fat intake was comparable between treatment groups within each age group (adults vs pediatric/adolescent), but placebo patients had a significant (p < 0.001) mean decrease in coefficient of fat absorption (adult, 36.9 percentage points; pediatric/adolescent, 34.9 percentage points) from open-label to double-blind treatment compared to pancrelipase patients (adult, 2 percentage points; pediatric/adolescent, 3.25 percentage points); this difference was caused by a greater (p < or = 0.001) increase in mean fecal fat excretion (grams per day) in the placebo groups compared to pancrelipase groups (adult: 61.9 vs 2.3; pediatric/adolescent: 45.4 vs 4.1). Change in mean stool frequency from open-label to double-blind phases was significantly different (p < or = 0.002) between treatment groups, with increases in placebo groups and no difference (adult) or decrease (pediatric/adolescent) in pancrelipase groups. Pancrelipase patients' stool consistency remained about the same from open-label to double-blind. Placebo patients' stool consistency decreased (became softer) from open-label pancrelipase to double-blind placebo. Clinical global improvement data showed that > or =83% of pancrelipase patients improved or remained unchanged.

CONCLUSIONS:

Enteric-coated, delayed-release (Minimicrospheres) pancrelipase capsules are an effective treatment for steatorrhea associated with pancreatic insufficiency in patients with cystic fibrosis.

• Authors: R C Stern, J D Eisenberg, J S Wagener, R Ahrens, M Rock, G doPico, D M Orenstein
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 95 Issue 8 Pg. 1932-8 (Aug 2000) ISSN: 0002-9270 [Print] United States
• PMID: 10950038 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gastrointestinal Agents
• Placebos
• Pancrelipase

Topics

• Adult
• Celiac Disease (drug therapy, etiology)
• Cystic Fibrosis (complications)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Exocrine Pancreatic Insufficiency (etiology)
• Female
• Gastrointestinal Agents (adverse effects, therapeutic use)
• Humans
• Male
• Pancrelipase (adverse effects, therapeutic use)
• Placebos (adverse effects, therapeutic use)
• Time Factors