The Efficacy of EUR-1008, a Novel Pancreatic Enzyme Product (PEP), in the Absence of Concurrent Agents Affecting Gastric pH, in Patients with Exocrine Pancreatic Insufficiency (EPI).

Background. Pancreatic enzyme replacement therapy is the standard of care for treatment of malabsorption in patients with cystic fibrosis (CF) and exocrine pancreatic insufficiency (PI).Aim. To evaluate efficacy and safety of a new formulation of pancrelipase (Ultrase MT20) in patients with CF and PI. Coefficients of fat absorption (CFA%) and nitrogen absorption (CNA%) were the main efficacy parameters. Safety was evaluated by monitoring laboratory analyses, adverse events (AEs), and overall signs and symptoms.Methods. Patients (n=31) were randomized in a crossover design comparing this pancrelipase with placebo during 2 inpatient evaluation periods (6-7 days each). Fat and protein/nitrogen ingestion and excretion were measured from food diaries and 72-hour stool collections. CFA% and CNA% were calculated for each period and compared.Results. Twenty-four patients provided analyzable data. This pancrelipase increased mean CFA% and CNA% (+34.7% and +25.7%, resp.,P<.0001for both), reduced stool frequency, and improved stool consistency compared with placebo. Placebo-treated patients reported more AEs, with gastrointestinal symptoms being the most frequently reported AE.Conclusions. This pancrelipase is a safe and effective treatment for malabsorption associated with exocrine PI in patients with CF.

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Randomized placebo controlled clinical trial of an enteric coated micro-pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency

Journal of Veterinary Internal Medicine ◽

10.1111/jvim.15235 ◽

2018 ◽

Vol 32 (5) ◽

pp. 1591-1599

Author(s):

Joseph Cyrus Parambeth ◽

Geoffrey T. Fosgate ◽

Jan S. Suchodolski ◽

Jonathan A. Lidbury ◽

Jörg M. Steiner

Keyword(s):

Clinical Trial ◽

Pancreatic Insufficiency ◽

Pancreatic Enzyme ◽

Exocrine Pancreatic Insufficiency ◽

Controlled Clinical Trial ◽

Enteric Coated ◽

Enzyme Supplement

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State of the Art in Exocrine Pancreatic Insufficiency

Medicina ◽

10.3390/medicina56100523 ◽

2020 ◽

Vol 56 (10) ◽

pp. 523

Author(s):

Carmelo Diéguez-Castillo ◽

Cristina Jiménez-Luna ◽

Jose Prados ◽

José Luis Martín-Ruiz ◽

Octavio Caba

Keyword(s):

Pancreatic Insufficiency ◽

Pancreatic Enzyme ◽

Bacterial Overgrowth ◽

Exocrine Pancreatic Insufficiency ◽

Enzyme Replacement ◽

Non Invasive ◽

Invasive Test ◽

Pancreatic Enzyme Replacement Therapy ◽

Risk Patients

Exocrine pancreatic insufficiency (EPI) is defined as the maldigestion of foods due to inadequate pancreatic secretion, which can be caused by alterations in its stimulation, production, transport, or interaction with nutrients at duodenal level. The most frequent causes are chronic pancreatitis in adults and cystic fibrosis in children. The prevalence of EPI is high, varying according to its etiology, but it is considered to be underdiagnosed and undertreated. Its importance lies in the quality of life impairment that results from the malabsorption and malnutrition and in the increased morbidity and mortality, being associated with osteoporosis and cardiovascular events. The diagnosis is based on a set of symptoms, indicators of malnutrition, and an indirect non-invasive test in at-risk patients. The treatment of choice combines non-restrictive dietary measures with pancreatic enzyme replacement therapy to correct the associated symptoms and improve the nutritional status of patients. Non-responders require the adjustment of pancreatic enzyme therapy, the association of proton pump inhibitors, and/or the evaluation of alternative diagnoses such as bacterial overgrowth. This review offers an in-depth overview of EPI in order to support the proper management of this entity based on updated and integrated knowledge of its etiopathogenesis, prevalence, diagnosis, and treatment.

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A Case of Chronic Pancreatic Insufficiency Due to Valproic Acid in a Child

Canadian Journal of Gastroenterology ◽

10.1155/2001/687087 ◽

2001 ◽

Vol 15 (2) ◽

pp. 127-130 ◽

Cited By ~ 5

Author(s):

Mary Anne Cooper ◽

Aubrey Groll

Keyword(s):

Valproic Acid ◽

Weight Loss ◽

Acute Pancreatitis ◽

Abdominal Pain ◽

Chronic Pancreatitis ◽

Pancreatic Insufficiency ◽

Pancreatic Enzyme ◽

Exocrine Pancreatic Insufficiency ◽

Radiological Evaluation ◽

Enzyme Replacement

A 14-year-old child treated with valproic acid over several years for a seizure disorder developed abdominal pain with radiological evidence of acute pancreatitis. The association with valproic acid was not recognized, and the child continued to take the drug. The patient eventually developed steatorrhea and weight loss that improved with pancreatic enzyme replacement. Radiological evaluation showed an atrophic pancreas. Without evidence of other etiological factors, valproic acid by itself appeared to be the cause of chronic pancreatitis with exocrine pancreatic insufficiency in this patient.

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Immunoreactive elastase I: clinical evaluation of a new noninvasive test of pancreatic function

Clinical Chemistry ◽

10.1093/clinchem/42.2.222 ◽

1996 ◽

Vol 42 (2) ◽

pp. 222-226 ◽

Cited By ~ 141

Author(s):

J Stein ◽

M Jung ◽

A Sziegoleit ◽

S Zeuzem ◽

W F Caspary ◽

...

Keyword(s):

Pancreatic Insufficiency ◽

Pancreatic Enzyme ◽

Correlation Coefficients ◽

Diagnostic Value ◽

Exocrine Pancreatic Insufficiency ◽

Pancreatic Function ◽

Noninvasive Test ◽

Enzyme Replacement ◽

Fecal Chymotrypsin ◽

Immunoreactive Elastase

Abstract We have evaluated the diagnostic value of the fecal elastase test in comparison with the secretin-pancreozymin test in the diagnosis of exocrine pancreatic insufficiency. Pancreatic elastase was measured immunologically. Immunoreactive elastase activity in spot stools from controls ranged from 136 to 4440 microgram/g; 95% of all values were within 175 to 1500 microgram/g. The elastase assay CVs ranged from 3.3% to 6.3% (intraassay) and from 4.1% to 10.2% (interassay). The output of elastase correlated well with those of amylase, lipase, and trypsin, yielding respective correlation coefficients of 0.83, 0.82, and 0.84 in controls and 0.86, 0.91, and 0.91 in patients with impaired pancreatic function. In contrast to fecal chymotrypsin, the test results were unaffected by pancreatic enzyme replacement therapy. These results indicate that fecal immunoreactive elastase may be recommended as a new, noninvasive tubeless test of pancreatic function.

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