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. 2012 Jul 19;7:77–91. doi: 10.2147/CE.S26705

Core evidence.

Clinical impact summary for pancrelipase and pancreatic exocrine insufficiency

Outcome measure Evidence Implications
Disease-oriented evidence Randomized, double-blind, placebocontrolled trials showed that pancreatic enzyme replacement therapy with pancrelipase even for short periods of a few weeks improved steatorrhea and the coefficient of fat absorption and of nitrogen absorption along with increase in body weight, in both pediatric and adult patients with chronic pancreatitis and cystic fibrosis Pancrelipase improves maldigestion and malnutrition, which leads to restoration of nutritional conditions, irrespective of age
Patient-oriented evidence
 Clinical symptoms Stool frequency, stool consistency, and abdominal pain were improved after PERT with pancrelipase PERT with pancrelipase ameliorates clinical symptoms effectively, with good tolerability and without serious adverse events
 Gastrointestinal adverse events Some gastrointestinal adverse events such as nausea, diarrhea, and abdominal pain, were observed
No serious adverse events were observed in clinical trials with pancrelipase approved by the US FDA
 Economic evidence Not available

Abbreviations: FDA, Food and Drug Administration; PERT, pancreatic enzyme replacement therapy.