Critical examination of therapeutic efficacy of a ph-sensitive enteric-coated pancreatic enzyme preparation in treatment of exocrine pancreatic insufficiency secondary to cystic fibrosis

1988 ◽  
Vol 33 (10) ◽  
pp. 1237-1244 ◽  
Author(s):  
Sudhir K. Dutta ◽  
S. Van Hubbard ◽  
Mark Appler
Keyword(s):  
Cystic Fibrosis ◽  
Therapeutic Efficacy ◽  
Enzyme Preparation ◽  
Pancreatic Insufficiency ◽  
Pancreatic Enzyme ◽  
Ph Sensitive ◽  
Exocrine Pancreatic Insufficiency ◽  
Critical Examination ◽  
Enteric Coated

scholarly journals Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis

2010 ◽  
Vol 2010 ◽  
pp. 1-7 ◽  
Author(s):  
Michael W. Konstan ◽  
Theodore G. Liou ◽  
Steven D. Strausbaugh ◽  
Richard Ahrens ◽  
Jamshed F. Kanga ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Pancreatic Insufficiency ◽  
Pancreatic Enzyme ◽  
Gastrointestinal Symptoms ◽  
Signs And Symptoms ◽  
Exocrine Pancreatic Insufficiency ◽  
Efficacy And Safety ◽  
Protein Nitrogen ◽  
Enzyme Replacement ◽  
New Formulation

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.

scholarly journals Cystic Fibrosis Treatment Options Discrepancy Globally

2022 ◽  
Vol 1 ◽  
Author(s):  
Rifa Gowani ◽  
Keyword(s):  
Cystic Fibrosis ◽  
Pancreatic Insufficiency ◽  
Treatment Options ◽  
Pancreatic Enzyme ◽  
Genetic Mutation ◽  
Exocrine Pancreatic Insufficiency ◽  
Monogenic Disease ◽  
Obstructive Pulmonary Disease ◽  
Enzyme Replacement ◽  
Proactive Therapy

Cystic fibrosis, or rather known as CF, is a common monogenic disease caused by genetic mutation on CFTR on chromosome 7. Progressive obstructive pulmonary disease, sinusitis, exocrine pancreatic insufficiency leading to malabsorption and malnutrition, liver and pancreatic dysfunction, and male infertility are all characteristics of the disease. Persistent pulmonary infections are caused by a lack of CFTR or its decreased function, leading to bronchiectasis and progressive lung destruction. Despite the fact that CF patients' lives are shortening, early diagnosis has helped improve patients' life span to a median age of around 50 years, including newborn screening, mild form identification, and a proactive therapy approach. Pancreatic enzyme replacement, respiratory physiotherapy, mucolytics, and strong antibiotic therapy are among treatments for CF. For the majority of people with severe symptoms, a lung or liver transplant is necessary. The CFTR protein is affected by a large number of mutations, each of which have diverse effects. Despite advances in our understanding of CFTR function and contemporary therapy, most of our knowledge of cystic fibrosis remains unclear. With the recent addition of mutation-specific treatments, future advances in health and quality of life for people with CF are likely to improve. The focus of research is on novel medications that restore CFTR function, some of which are now accessible and have a positive therapeutic impact, while others are showing promising preliminary results.

scholarly journals Bruising as the first sign of exocrine pancreatic insufficiency

2019 ◽  
Author(s):  
Csilla Enikő Szabo ◽  
Oana Iulia Man ◽  
Radu Sorin Șerban ◽  
Eva Kiss ◽  
Călin Florin Lazăr
Keyword(s):  
Cystic Fibrosis ◽  
Vitamin K ◽  
Pancreatic Insufficiency ◽  
Pancreatic Enzyme ◽  
Exocrine Pancreatic Insufficiency ◽  
Nutritional Deficiencies ◽  
Deficiency Anemia ◽  
Serum Lipase ◽  
Pancreatic Elastase ◽  
Enzyme Replacement

Exocrine pancreatic insufficiency is an important cause of chronic malnutrition, secondary to maldigestion-malabsorption, which can be caused in children especially by cystic fibrosis, but also by other much rarer diseases. The case of a 6 months and 3 weeks old male pediatric patient is reported, who was admitted to the clinic for head and forearms bruising. Laboratory findings identified vitamin K deficiency as the cause of the cutaneous hemorrhagic syndrome. Further investigations revealed association of steatorrhea (which is a marker of fat malabsorption), iron-deficiency anemia and hypovitaminosis D, which had been produced by nutritional deficiencies caused by malabsorption syndrome. From the numerous disorders that could be associated with pancreatic insufficiency in children, the following conditions had been excluded: cystic fibrosis (mucoviscidosis), cow`s milk protein intolerance, gluten-sensitive enteropathy (coeliac disease), Shwachman-Diamond syndrome, abetalipoproteinemia, etc. Based upon decreased levels of stool pancreatic elastase in repeated measurements, together with low serum lipase, the final diagnosis of exocrine pancreatic insufficiency was established. Treatment of this case consisted mainly in pancreatic enzyme replacement therapy, but also oral iron supplementation and dietary supplements with fat-soluble vitamins (A, D, E, K). The outcome was favorable, characterized by normalization of intestinal passage, ascending growth curve and normalization of the majority of laboratory tests values that were modified between the time of patient admission to our clinic and initiation of specific therapy (serum level of vitamin K, vitamin D and lipase, coagulation profile, hemoglobin and red blood cell indexes), as well as higher value of fecal pancreatic elastase.    

Romanian Guidelines on the Diagnosis and Treatment of Exocrine Pancreatic Insufficiency

2015 ◽  
Vol 24 (1) ◽  
pp. 117-123 ◽  
Author(s):  
Cristian Gheorghe ◽  
Andrada Seicean ◽  
Adrian Saftoiu ◽  
Marcel Tantau ◽  
Eugen Dumitru ◽  
...  
Keyword(s):  
Enzyme Replacement Therapy ◽  
Replacement Therapy ◽  
Clinical Symptoms ◽  
Pancreatic Insufficiency ◽  
Pancreatic Enzyme ◽  
Exocrine Pancreatic Insufficiency ◽  
Exocrine Function ◽  
Enzyme Replacement ◽  
Pancreatic Enzyme Replacement Therapy ◽  
Enteric Coated

In assessing exocrine pancreatic insufficiency (EPI), its diverse etiologies and the heterogeneous population affected should be considered. Diagnosing this condition remains a challenge in clinical practice especially for mild-to-moderate EPI, with the support of the time-consuming breath test or the coefficient of fat absorption. The fecal elastase-1 test, less precise for the diagnosis, cannot be useful for assessing treatment efficacy. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment, whereby enteric-coated mini-microspheres are taken with every meal, in progressive doses based on an individual's weight and clinical symptoms. The main indication for PERT is chronic pancreatitis, in patients who have clinically relevant steatorrhea, abnormal pancreatic function test or abnormal function tests associated with symptoms of malabsorption such as weight loss or meteorism. While enzyme replacement therapy is not recommended in the initial stages of acute pancreatitis, pancreatic exocrine function should be monitored for at least 6-18 months. In the case of unresectable pancreatic cancer, replacement enzyme therapy helps to maintain weight and improve overall quality of life. It is also indicated in patients with celiac disease, who have chronic diarrhea (in spite of gluten-free diet), and in patients with cystic fibrosis with proven EPI.

Treatment of Pancreatic Exocrine Insufficiency with Enteric Coated Pancreatin Formulations: An Overview

2013 ◽  
Vol 6 (3) ◽  
pp. 2125-2130
Author(s):  
B K Bhattacharyya ◽  
S Chowdhury ◽  
S Das ◽  
S Mukherjee ◽  
D Bhattacharjee
Keyword(s):  
Cystic Fibrosis ◽  
Digestive Enzymes ◽  
Pancreatic Insufficiency ◽  
Pancreatic Enzyme ◽  
Pancreatic Exocrine Insufficiency ◽  
Exocrine Insufficiency ◽  
Enzyme Replacement ◽  
Increased Risk ◽  
Pancreatic Exocrine ◽  
Enteric Coated

Pancreatin is a mixture of several digestive enzymes produced by the exocrine cells of the pancreas. It is composed of amylase, lipase and protease. It is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy, pancreatitis and cystic fibrosis. Pancreatin products contain the pancreatic enzymes trypsin, amylase and lipase. The patients with pancreatic diseases often suffer from pancreatic exocrine insufficiency. In such condition pancreas does not secrete required amount of digestive enzymes for proper digestion to occur. Severe pancreatic insufficiency occurs in cystic fibrosis, chronic pancreatitis, tumors or after surgical resection. Thus pancreatic exocrine insufficiency may result in clinical manifestation of malnutrition, weight loss and steatorrhea leading towards the increased risk of morbidity and mortality. For the improvement of clinical symptoms, restriction of fat intake and pancreatic enzyme replacement therapy are recommended. The enzyme substitution therapy is very much challenging because the optimal enzyme dose is highly variable to mimic the physiological pattern of pancreatic exocrine secretion. Regulatory authorities have approved several pancreatic enzyme formulations in the form of enteric coated minimicrosphere which are now available commercially. This review focuses on the physiological considerations of   pancreatic exocrine insufficiency and its treatment with enteric coated pancreatin formulations. 

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