A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery

Abstract

Re-use of this article is permitted in accordance with the Terms and Conditions set out at http:// wileyonlinelibrary.com/onlineopen# OnlineOpen_Terms SUMMARY Background Pancreatic enzyme replacement therapy (PERT) is necessary to prevent severe maldigestion and unwanted weight loss associated with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS).

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

“…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].…”

“…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].…”

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].…”

Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test

“…Impairments in fat digestion affect the absorption of the fatsoluble vitamins A, D, E, and K, all of which, together with other PEI-related nutritional deficits, could be associated with complications such as cardiovascular disease, compromised immunity, cancerogenicity, psychological disorders, hypoprothrombinemia, bleeding disorders, night blindness, and muscle weakness [10][11][12]. Early detection of PEI can help prevent malabsorption-/malnutrition-associated complications by enabling expedient treatment with pancreatic enzyme replacement therapy (PERT), which numerous clinical trials have shown to be highly effective, not only in patients with CP, but also following pancreatic surgery, and in children and adults with CF [6,[13][14][15][16]. Clinically, the most common cause of PEI is CP, although symptoms of PEI may not appear until several years after disease onset [17].…”