Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: A multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study
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2015, PancreatologyCitation Excerpt :However, these studies did not sub-group patients by PEI status; therefore the reductions in muscle and fat stores cannot be correlated with PEI. Assessment of changes in clinical symptoms appears to be a valid marker of PEI improvement in patients with PEI receiving PERT, based on significant improvements in intervention studies in measures such as stool characteristics, bloating, flatulence and abdominal symptom score [29–33,48–54]. However, a few patients have reported worsening of clinical symptoms, and a study investigating nutritional status in patients with PEI on PERT found that improvement in clinical symptoms did not always signify normal nutritional status [28].
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