EEVALUATE SAFETY & EFFICACY OF EURAND PEP CYSTIC FIBROSIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Exocrine pancreatic insufficiency (EPI) is characterized by poor absorption of fats, proteins and carbohydrates, which is primarily observed in cystic fibrosis (CF). Treatment of EPI in patients with CF with pancreatic enzyme products (PEPs) has been well established over the last thirty years. There have been many studies indicating efficacy and safety at least for short term use. High doses of PEPs, however, in some studies have been associated with increased risk of developing fibrosing colonopathy. Because most PEPs were developed before current FDA requirements and the possible safety risk of higher doses, the FDA wants safety and efficacy trials complete