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Randomized Controlled Trial
. 2011 Sep;10(5):350-6.
doi: 10.1016/j.jcf.2011.04.005. Epub 2011 May 31.

Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis

Bruce C Trapnell  1 , Steven D Strausbaugh, Marlyn S Woo, Shin-Yir Tong, Steven A Silber, Andrew E Mulberg, Gerhard Leitz
Affiliations
Free article
Randomized Controlled Trial

Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis

Bruce C Trapnell et al. J Cyst Fibros. 2011 Sep.
Free article

Erratum in

  • J Cyst Fibros. 2011 Dec;10(6):491-2

Abstract

Background: Pancreatic enzyme replacement therapy (PERT) is critical for correction of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

Methods: This was a randomized, placebo-controlled PERT withdrawal study evaluating the efficacy and safety of PANCREAZE® (pancrelipase) in CF patients with EPI. Participants (n=49) entered an open-label, ≤ 14 day run-in phase, maintained a high-fat diet (100 ± 15 g/day), and received PANCREAZE® (10.5 or 21). Participants with a coefficient of fat absorption (CFA)≥ 80% (n=40) were then randomized (1:1) to receive either PANCREAZE® or placebo during a double-blind, ≤ 7 day withdrawal phase.

Results: PANCREAZE® improved fat absorption as shown by significantly lower mean ± SD change in CFA between open-label and double-blind phases for PANCREAZE® (-1.5 ± 5.88%; p<0.001) compared to placebo (-34.1 ± 23.03%). Protein absorption was similarly improved. No unexpected adverse events were reported.

Conclusions: This study demonstrated PANCREAZE® was effective in treating EPI due to CF and was safe and well tolerated.

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