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primary studies published RCT

Efficacy and safety of PANCREAZE(R) for treatment of exocrine pancreatic insufficiency due to cystic fibrosis.

  • Year: 2011
  • Date: 2011
  • Author: Trapnell BC
Source

J Cyst Fibros. 2011 Sep;10(5):350-6. Epub 2011 May 31.

Study design (if review, criteria of inclusion for studies)

randomized, placebo-controlled study

Participants

n=49

Interventions

Participants (n=49) entered an open-label, /= 80% (n=40) were then randomized (1:1) to receive either PANCREAZE(R) or placebo during a double-blind,

Outcome measures

fat absorption, protein absorption, adverse events

Main results

PANCREAZE(R) improved fat absorption as shown by significantly lower mean +/- SD change in CFA between open-label and double-blind phases for PANCREAZE(R) (-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

Authors' conclusions

This study demonstrated PANCREAZE(R) was effective in treating EPI due to CF and was safe and well tolerated.

Related topics

A, E, K vitamins supplementation

Agents which reduce gastric acidity in cystic fibrosis

Calorie supplements in cystic fibrosis

General nutrition recommendations in cystic fibrosis

Pancreatic enzyme replacement therapy in cystic fibrosis

Vitamin D supplementation

Keywords: Gastrointestinal Agents; Gastrointestinal Diseases; pharmacological_intervention; Pancreas insufficiency; Pancreatic Diseases; Pancreatic Enzyme Replacement Therapy; Supplementation; Malabsorption; Nutrition Disorders;