A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis

Pancreatic exocrine insufficiency in pancreatic cancer: A review of the literature

“…Most recent, open-labelled PERT trials lasting for 6-12 months did not report significant adverse drug reactions either [89,90].…”

Clinical, anthropometric and laboratory nutritional markers of pancreatic exocrine insufficiency: Prevalence and diagnostic use

“…A further study investigating the prevalence of low RBP in relation to exocrine function in patients with CP found a substantial difference: 24% (8/33) with PEI and 8% (5/59) without [81]. As for prealbumin, low RBP was a less frequent finding in randomized clinical trials of CP patients with PEI and ongoing PERT [48,82].…”

“…Abnormally low total plasma protein levels appear to be an infrequent finding in patients with CP and PEI [48,81,82], and 1 study found no statistically significant difference between patients with ( [40,81]. Other studies of patients with CP and PEI on PERT showed mean levels within the normal range [48,82]. Two studies in CF cohorts with PEI (1 study on PERT, 1 not specified) found normal serum albumin levels [43,65].…”

“…European studies have indicated a prevalence of 23% [28] and 24% [81] in CP patients with PEI and 5% in those without [81]. Randomized clinical trials including more selected patient cohorts with CP and PEI and ongoing PERT in Europe and India reported prealbumin within normal ranges [48,82].…”

“…Two studies could not find evidence for a higher prevalence of iron deficiency in CP patients with PEI versus those without [28,81], and in a clinical trial assessing PERT in patients with PEI due to CP (who had received previous PERT), mean transferrin levels were within the normal range at baseline [82]. A small study of patients with CF found 74% of subjects with iron deficiency; however, the degree of deficiency was associated with the severity of suppurative lung manifestations and unrelated to PERT use [95].…”