Pancreatic Enzyme Replacement Research Articles

Adherence to pancreatic enzyme replacement therapy among patients with chronic pancreatitis in East China: a mixed methods study

Pancreatic enzyme replacement therapy (PERT) has been recommended as the preferred method for pancreatic exocrine insufficiency caused by chronic pancreatitis (CP). However, at present, the patient-related factors for the poor PERT management are not clear, and there are no studies on the adherence to PERT in patients with CP in East China. This was a mixed-method study following the principle of sequential explanatory design and included two parts: a quantitative and qualitative study. A cross-sectional survey of medication adherence (MA) was first carried out, followed by a semi-structured interview to further explore and explain the influencing factors of adherence to PERT. Of the 148 patients included in this study, 48.0% had poor MA and only 12.8% had good MA. Multivariate logistic regression showed that lower levels of education and income were contributing factors for non-adherence to PERT. Semi-structured interviews with 24 patients revealed that the reasons for non-adherence also included lack of knowledge, self-adjustment of PERT, lifetime of medication, side effects of PERT, forgetfulness, financial burdens, and accessibility issues. The adherence to PERT was poor among patients with CP in East China. Healthcare providers should personalize medication strategies to improve patients’ MA.

THU261 Etiologic Factors, Contributors, And Associations For Exocrine Pancreatic Insufficiency

Abstract Disclosure: K.G. Romo: None. A. Noor: None. A. Zia: None. S. Shu: None. S. Bhamre: None. W.A. West: None. B.M. Hoard: None. G.I. Uwaifo: None. Introduction: Exocrine pancreatic insufficiency (EPI) is a clinical condition which though presumed to be uncommon has grown in prominence and recognition in recent years. The fact that pancreatic enzyme replacement therapy (PERT) is available to ameliorate many of the metabolic and gastrointestinal sequelae of EPI makes its early recognition, diagnosis, and treatment very important. Since EPI appears uncommon, improved quantification of its prevalence and identification of associated etiologic factors could inform targeted screening in select patient populations. Our study is a retrospective chart analysis of a large multi-specialty, multi-institutional practice group covering much of Louisiana and seeks to provide needed information regarding EPI prevalence and etiologic factors. Methods: A retrospective review of the entire 1.3 million patient-practice of the Ochsner Health system in Louisiana was performed to cover the period from January 2017 to January 2020. All cases of documented EPI and patients on PERT were identified—these were then further interrogated including individual chart review to identify etiologic factors and obtain relevant cardiometabolic, demographic, vital sign data, and clinical course information. Results: A total of 677 EPI patients were identified with a prevalence of 0.525% among patients with diabetes (DM) and 0.051% in the general outpatient population. EPI, though uncommon, is thus ∼ 10x more prevalent among DM patients. The identified etiologic factors were Type 2 diabetes (T2DM) (44.6% of cases), general cancer (15.9%), secondary diabetes (11.5%), cystic fibrosis (12.9%), Type 1 diabetes (T1DM) (9.6%), pancreatic cancer (6.6%), idiopathic (6.2%), pancreatitis (5%), pancreatic surgery (2.95%), hemochromatosis-hemosiderosis (0.44%), and alpha-1 antitrypsin deficiency (0.15%). Several patients in the cohort had multiple identified etiologic factors. Discussion and Conclusions: While EPI is uncommon in the general population it is at least 10x more prevalent among DM patients. Etiologic factors provide a clinical pathway for targeted clinical and lab screening to enable early diagnosis and treatment. Since T2DM is the most common etiologic factor for EPI in our cohort and other reported series, there is need for further in-depth study to identify potentially modifiable factors and possible predictors in the progression of DM to EPI and whether PERT can ameliorate associated cardio-metabolic and ASCVD risk surrogates. Presentation: Thursday, June 15, 2023

1677P Pancreatic enzyme replacement therapy improves survival in patients receiving nab-paclitaxel plus gemcitabine as first-line treatment for advanced pancreatic adenocarcinoma

1677P Pancreatic enzyme replacement therapy improves survival in patients receiving nab-paclitaxel plus gemcitabine as first-line treatment for advanced pancreatic adenocarcinoma

523 Phase 1 study of SNSP-003—a non-porcine pancreatic enzyme replacement therapy—using a novel endpoint

523 Phase 1 study of SNSP-003—a non-porcine pancreatic enzyme replacement therapy—using a novel endpoint

127 Dual delivery microbial enzymatic product as alternative pancreatic enzyme replacement therapy for people with cystic fibrosis

127 Dual delivery microbial enzymatic product as alternative pancreatic enzyme replacement therapy for people with cystic fibrosis

The Hong Kong consensus recommendations on the diagnosis and management of pancreatic cystic lesions.

The finding of pancreatic cystic lesions (PCL) on incidental imaging is becoming increasingly common. International studies report a prevalence of 2.2-44.7% depending on the population, imaging modality and indication for imaging, and the prevalence increases with age. Patients with PCL are at risk of developing pancreatic cancer, a disease with a poor prognosis. This publication summarizes recommendations for the diagnosis and management of PCL and post-operative pancreatic exocrine insufficiency (PEI) from a group of local specialists. Clinical evidence was consolidated from narrative reviews and consensus statements formulated during two online meetings in March 2022. The expert panel included gastroenterologists, hepatobiliary surgeons, oncologists, radiologists, and endocrinologists. Patients with PCL require careful investigation and follow-up due to the risk of malignant transformation of these lesions. They should undergo clinical investigation and pancreas-specific imaging to classify lesions and understand the risk profile of the patient. Where indicated, patients should undergo pancreatectomy to excise PCL. Following pancreatectomy, patients are at risk of PEI, leading to gastrointestinal dysfunction and malnutrition. Therefore, such patients should be monitored for symptoms of PEI, and promptly treated with pancreatic enzyme replacement therapy (PERT). Patients with poor response to PERT may require increases in dose, addition of a proton pump inhibitor, and/or further investigation, including tests for pancreatic function. Patients are also at risk of new-onset diabetes mellitus after pancreatectomy; they should be screened and treated with insulin if indicated. These statements are an accurate summary of our approach to the diagnosis and management of patients with PCL and will be of assistance to clinicians treating these patients in a similar clinical landscape.

A-340 CFTR Modulator Therapy Increases Serum/Plasma Concentrations of Vitamin a in People with Cystic Fibrosis

Abstract Introduction Pancreatic insufficiency (PI) is common in people with Cystic Fibrosis (PwCF), contributing to malabsorption of fat and fat-soluble vitamins. Thus, PI PwCF are prescribed pancreatic enzyme replacement therapy (PERT) and supplementation with fat-soluble vitamins. The circulating vitamin levels are monitored to guide dietary therapy. Currently, there are multiple cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies available that have shown significant improvements in pulmonary function, anthropometric parameters, and life expectancy in PwCF, but the effects on serum/plasma fat-soluble vitamin levels remain unknown. The goal of this study was to determine how modulator therapy affects serum/plasma vitamin A and E levels in individuals with CF. Methods The analysis included 1139 serum/plasma samples from 157 children and adolescents with CF: 74 males, 83 females, between the ages of 2–17 years. Most individuals were homozygous or compound heterozygous for the F508del variant (n = 81 and n = 72, respectively). 141 individuals (90%) were diagnosed with PI (fecal elastase <200 μg/g stool). 76 individuals (48%) received different CFTR modulator therapies for at least 1 month. Vitamin A (retinol and retinyl palmitate) and Vitamin E (α-tocopherol and γ-tocopherol) were measured using a high-performance liquid chromatography assay. Data analyses were performed in Prism software (La Jolla, CA), and statistical significance was defined as P < 0.05. The study was approved by the IRB. Results Overall, vitamin deficiency was rarely observed in PwCF prescribed PERT and vitamin supplements; <3% of them had low concentrations of Vitamin A and/or E. The proportion of individuals with Vitamin A and/or E above the reference range was larger; 10.9% and 30.8% for Vitamin A and E, respectively, most likely reflecting supplementation. There was no correlation of plasma vitamin A or E results with sex, weight-for-age, height-for-age, or BMI-for-age. However, pancreatic status affected vitamin levels in individuals not taking modulators: samples from PI PwCF (n = 367) had significantly lower Vitamin A and E than those from PS PwCF (n = 71). In contrast, we have observed higher concentrations of Vitamin A retinol in individuals on modulators: 0.49 ± 0.13 mg/L on modulators vs 0.43 ± 0.12 mg/L without modulators. Pairwise analysis of samples from 76 individuals before and after modulator therapy confirmed this finding, showing an average 16% increase in serum/plasma retinol concentration (P < 0.0001). No changes in retinol were observed between different measurements in PwCF who were not taking modulators (n = 82). Vitamin E levels were not impacted by modulator therapy. Conclusions Advances in clinical care improved fat-soluble vitamin status in people with CF. However, even when supplemented and on PERT, PI PwCF not on modulators tend to have lower fat-soluble vitamin concentrations than PS PwCF. CFTR modulator therapy increases serum/plasma concentrations of vitamin A. Thus, individuals receiving modulators and vitamin supplementation should be monitored to avoid Vitamin A toxicity. This is especially true for PS PwCF who already have higher baseline vitamin levels.

Changes in fecal elastase-1 following initiation of CFTR modulator therapy in pediatric patients with cystic fibrosis

BackgroundImprovement in exocrine pancreatic function in persons with CF (pwCF) on cystic fibrosis transmembrane conductance regulator (CFTR) modulators has been documented in clinical trials using fecal pancreatic elastase-1 (FE-1). Our group endeavored to evaluate real-world data on FE-1 in children on CFTR modulator therapy at three pediatric cystic fibrosis (CF) centers. MethodsPediatric pwCF were offered FE-1 testing if they were on pancreatic enzyme replacement therapy (PERT) and on CFTR modulator therapy according to their center's guideline. FE-1 data were collected retrospectively. The primary outcome was absolute change in FE-1. Results70 pwCF were included for analysis. 53 had baseline and post-modulator FE-1 values. There was a significant increase in FE-1 from median 25 mcg/g (IQR 25–60) at baseline to 57 mcg/g (IQR 20–228) post-modulator (p<0.001 by Wilcoxon matched pairs), with an absolute change in FE-1 of median 28 mcg/g (IQR –5–161) and mean 93.5 ± 146.8 mcg/g. Age was negatively correlated with change in FE-1 (Spearman r=-0.48, p<0.001). 15 pwCF (21%) had post-modulator FE-1 values ≥200 mcg/g, consistent with pancreatic sufficiency (PS). The PS group was significant for younger age at initiation of first CFTR modulator and a higher baseline FE-1. ConclusionsMost pwCF experienced an increase in FE-1 while receiving CFTR modulator treatment and a small percentage demonstrated values reflective of PS. These data suggest that PS may be attained in those that initiated modulator therapy at a younger age or had a higher baseline FE-1. FE-1 testing is suggested for children on any CFTR modulator therapy.

Advances in the Management of Pain in Chronic Pancreatitis.

The data on recent advances in managing chronic pancreatitis (CP) pain is limited. This review highlights the role of endotherapy and the advances in the overall management of pain in CP. Of late, pancreatic biodegradable stents have been used in endotherapy with appreciable success. These include slow, medium, and fast degrading stents, which optimize the overall management of CP and could prevent the need for multiple procedures. Endoscopic ultrasound-guided celiac plexus block is reserved in selected patients to treat debilitating pain. Total pancreatectomy with islet autotransplantation in small duct disease has shown promising results. The indications for treating pain in CP with endoscopy and surgery need to be better defined. The complexity of pain control due to the incomplete understanding of pathomorphology makes the management of CP challenging. The current treatment methods are still evolving. Therapy aims to reduce pain, optimize recovery, maintain quality of life, and meet postoperative needs. Initial management includes lifestyle modification, nutrition optimization, risk factor reduction with abstinence from alcohol, cessation of tobacco and smoking. Supportive medical management involves the judicial use of analgesics, neuromodulators, antioxidants, pancreatic enzyme replacement for insufficiency, and diabetes management. Patients with intractable pain are ideal for therapeutic intervention. Being less invasive with an acceptable complication rate makes endotherapy the preferred first-line treatment. If found to be cost-effective, biodegradable stents can reduce the overall cost. Unfortunately, if patients remain symptomatic, surgery is preferred in case of failure or recurrence. For optimal results, appropriate patient selection is vital to maximizing outcomes.

Perioperative management of pancreatic exocrine insufficiency–evidence-based proposal for a paradigm shift in pancreatic surgery

BackgroundDespite exocrine pancreatic insufficiency (EPI) being a significant consequence of pancreatic surgery, there is still no consensus on its perioperative management. This study aimed to evaluate unselective pancreatic enzyme replacement therapy (PERT). MethodsA prospective, observational study of patients undergoing partial pancreatectomy was conducted. EPI status was assessed pre- and postoperatively, based on three fecal-elastase measurements each. Characteristic symptoms were evaluated by questionnaire. In 85 post-surgical patients, the subjective burden of PERT was measured. Results101 patients were followed prospectively. Preoperative EPI screening was available for 83 patients, of which 48% were diagnosed with preexisting EPI. Of those patients with regular exocrine function, 54% developed EPI de novo; this rate being higher following pancreatic head resections (72%) compared to left-sided pancreatectomies (LP) (20%) (p = 0.016). Overall postoperative EPI prevalence was significantly greater following pancreatic head resections (86%) than LP (33%) (p < 0.001). Only young and female patients described a significant burden related to PERT. ConclusionFor all patients undergoing pancreatic head resection PERT should be considered beginning prior to surgery, due to the subgroup's high EPI rate and the comparatively low burden of PERT. Patients with LP are at lower risk and should be pre- and postoperatively screened and supplemented accordingly.

Impact of refrigeration and freezing-thawing of breast milk on in vitro digestibility and liposoluble vitamin bioaccessibility in breast-fed infants

There is little information about the impact of refrigeration and freezing-thawing on breast milk digestibility under gastrointestinal conditions of healthy infants or those requiring pancreatic enzyme replacement therapy (PERT) such as infants with cystic fibrosis (CF). This study assessed the impact of refrigeration and freezing-thawing on fat and protein digestibility and liposoluble vitamin bioaccessibility of breast milk. In vitro digestion models mimicking both healthy infant and CF infant conditions were applied. Freezing-thawing significantly increased the fat globule particle size. For CF digestion, this change had a more negative impact when using a freezing-thawing process than when using refrigeration of breast milk, reducing lipolysis (up to 18%), proteolysis (up to 28%), and vitamin A and E bioaccessibility. Under healthy conditions, no significant effects were detected. An adequate pancreatic enzyme replacement therapy (PERT) dose (25 LU/mL of BM) would enable the same level of lipolysis (55%) as in the healthy scenario. In conclusion, breast milk is the only source of energy and nutrients for breast-fed infants, so to prevent the loss of nutrient absorption, those with CF should not be fed with frozen-thawed breast milk.

Survey of Pancreatic Enzyme Replacement Therapy Dosing Experiences in Adults with Exocrine Pancreatic Insufficiency.

Pancreatic enzyme replacement therapy (PERT) is essential for treating exocrine pancreatic insufficiency (EPI), a condition where the pancreas does not produce adequate enzymes for digestion. This study delves into the real-world experiences of individuals with EPI regarding their PERT usage. A study was executed using a tailored survey targeting individuals with EPI. Quantitative data analysis assessed factors such as age, duration of EPI, elastase levels, choice of PERT, perceived effectiveness of titration, and the time taken for effective titration. The study comprised 111 participants, predominantly female (93%) and hailing from North America (79%). Of these, 36.7% had been diagnosed with EPI for 3 or more years. A significant 72% felt they were not consistently consuming adequate enzymes, with only 22% believing their intake was sufficient. There were 44 participants (42%) still in the process of adjusting their enzyme doses. In contrast, 17 participants (16%) took a few weeks, 21 (20%) a few months, 11 (10%) over six months, 10 (9%) more than a year, and 3 (3%) several years for dose adjustment. Regarding enzyme titration advice, 30 participants (29%) received vague guidance, while 22 (21%) found the advice beneficial. This study underscores the pressing need for enhanced PERT dosing guidance. The insights gleaned spotlight the prevalent undertreatment across the entire EPI demographic, including in those with lesser-studied co-conditions.

Nanoformulation of lipase from Porcine pancreas by electrospinning as a novel alternative for enzyme-based per os therapies

Pancreatic enzyme replacement therapy (PERT) treats pancreatic insufficiency, causing a lack of digestive enzymes due to pancreatic damage or dysfunction. However, traditional PERT faces challenges such as poor stability and limited efficiency of the enzymes. Lipase from Porcine pancreas (PpL) is commonly applied for PERT, however only classic formulas such as tablets or capsules produced from physical mixture of the enzyme and excipients had been developed. Electrospinning produces nanofibers that are promising as drug carriers, due to their high surface area-to-volume ratio and tunable physicochemical properties. In this study we investigated the direct nanoformulation of PpL applying polymer nanofibers. The effect of water-soluble and water-resist polymers (PVA: polyvinyl alcohol, PVP: polyvinylpyrrolidone and PLA: polylactic acid) on the physicochemical properties of precursor for electrospinning and on the nanofibers produced from them was systematically investigated. The immobilization of PpL using electrospun nanofibers by entrapment and adsorption methods was developed and compared the enzymatic activities of the nanofibrous formulas. It was found that immobilization using nanofibers in all cases caused a large increase in the enzymatic activity of PpL. Our research demonstrates that nanoformulation of PpL could be efficient by electrospinning technique and the polymer has dominant effect on the enzymatic and structural properties of formulas since PpL entrapped in PLA showed the highest enzymatic activity. Nanofibrous enzyme loaded formulations were comprehensively studied by rheology, scanning electron (SEM) and Raman microscopy, water content determination, positron annihilation lifetime spectroscopy (PALS) and enzyme activity assay of ester hydrolysis.

Evaluation of Nutritional Status and the Impact of Nutritional Treatment in Patients with Pancreatic Cancer.

Patients with pancreatic cancer who develop irreversible cancer cachexia have a life expectancy of less than 3 months. Therefore, it is extremely important to evaluate the patient's nutritional status as early as possible and to implement an appropriate nutritional intervention in order to reduce the risk of further weight loss and/or muscle loss, which affect the outcomes of cancer treatment and the correct nutritional treatment in patients with pancreatic cancer. A literature review was performed by using the PubMed and Cochrane quick search methodology. The main purpose of this review was to present the current approach to nutritional treatment in pancreatic cancer. The review included publications, most of which concerned clinical nutrition as part of the phase of treatment of patients with pancreatic cancer, nutritional and metabolic disorders in pancreatic cancer, and the period after pancreatic resection. Some of the publications concerned various nutritional interventions in patients with pancreatic cancer undergoing chemotherapy or surgical treatment (nutritional support before surgery, after surgery, or during palliative treatment). There is an unmet need for integrated nutritional therapy as a key part of the comprehensive care process for PC patients. Nutritional counseling is the first line of nutritional treatment for malnourished cancer patients, but pancreatic enzyme replacement therapy also constitutes the cornerstone of nutritional treatment for relieving symptoms of indigestion and maintaining or improving nutritional status.

Dietary therapy for patients with chronic pancreatitis in Japan: a cross-sectional online survey of physicians and registered dietitians.

This study was aimed towards understanding the current status of dietary therapy for patients with pancreatic exocrine insufficiency (PEI) in Japan and its alignment with Japanese recommendations for high-fat intake and concomitant high-potency pancreatic enzyme replacement therapy (PERT) by surveying treating physicians and registered dietitians. The 19-item physicians' online questionnaire collected data about the number of patients with PEI treated, methods used to assess PEI and nutritional status in patients with PEI, as well as provision of dietary guidance and details of treatment with PERT. The 10-item registered dietitians' online questionnaire captured data about the provision of dietary guidance, including setting (inpatient or outpatient) and details of nutritional guidance provided to patients. Overall, 35 physicians and 23 dietitians completed the respective questionnaires. The primary cause of PEI in patients treated by physicians during the previous month was chronic pancreatitis (80.5%). Of 30 (86%) physicians who reported implementing dietary guidance for patients with PEI, less than half (43%) followed national guidelines and most (83%) implemented a low-fat diet. The use of PERT in recently treated patients with PEI was low. Amongst 11 (48%) dietitians who reported providing dietary guidance to patients with chronic pancreatitis and PEI, 7 (64%) recommended restricting fat intake in patients with uncompensated chronic pancreatitis. Dietitians overall were more likely to provide guidance about alcohol avoidance (91%) than smoking cessation (48%) to appropriate patients. This survey suggests that additional educational efforts are required to align the management practices of physicians and registered dietitians with evidence-based clinical practice guidelines for Japanese patients with chronic pancreatitis and PEI.

Untargeted Analysis of Serum Metabolomes in Dogs with Exocrine Pancreatic Insufficiency.

Exocrine pancreatic insufficiency (EPI) is a malabsorptive syndrome resulting from insufficient secretion of pancreatic digestive enzymes. EPI is treated with pancreatic enzyme replacement therapy (PERT), but the persistence of clinical signs, especially diarrhea, is common after treatment. We used untargeted metabolomics of serum to identify metabolic disturbances associated with EPI and generate novel hypotheses related to its pathophysiology. Fasted serum samples were collected from dogs with EPI (n = 20) and healthy controls (n = 10), all receiving PERT. Serum metabolomes were generated using UPLC-MS/MS, and differences in relative metabolite abundances were compared between the groups. Of the 759 serum metabolites detected, 114 varied significantly (p < 0.05, q < 0.2) between dogs with EPI and healthy controls. Differences in amino acids (arginate, homoarginine, 2-oxoarginine, N-acetyl-cadaverine, and α-ketoglutaramate) and lipids (free fatty acids and docosahexaenoylcarnitine) were consistent with increased proteolysis and lipolysis, indicating a persistent catabolic state in dogs with EPI. Relative abundances of gut microbial metabolites (phenyllactate, 4-hydroxyphenylacetate, phenylacetyl-amino acids, catechol sulfates, and o-cresol-sulfate) were altered in dogs with EPI, consistent with disruptions in gut microbial communities. Increased kynurenine is consistent with the presence of intestinal inflammation in dogs with EPI. Whether these metabolic disturbances participate in the pathophysiology of EPI or contribute to the persistence of clinical signs after treatment is unknown, but they are targets for future investigations.

Improvement of lipid and lipoprotein profiles in children and adolescents with cystic fibrosis on CFTR modulator therapy

BackgroundAssociation of a high-fat diet with increased risks of cardiovascular disease (CVD) and type 2 diabetes, has prompted evaluation of lipids in people with CF (pwCF). However, most evidence on dyslipidemia was published before CF transmembrane conductance regulator (CFTR) modulators became a standard of care. The main goal of this study was to investigate the effect of CFTR modulator therapies on lipid and lipoprotein profiles in children and adolescents with CF. MethodsBlood samples were collected from 153 pwCF (10.1 ± 4.7 years of age) and 60 age-matched controls. Most pwCF were pancreatic insufficient on pancreatic enzyme replacement therapy. By the end of the study, 65% of CF participants were on CFTR modulator therapy for >1 month. The results of traditional and advanced lipid testing in pwCF were correlated with clinical and dietary information. ResultsTotal cholesterol and low-density lipoprotein (LDL) cholesterol were significantly lower in pwCF compared to non-CF participants. Those not receiving CFTR modulators also had significantly lower high-density lipoprotein (HDL) cholesterol and HDL particle number than controls. Individuals with CF on modulator therapy had significantly higher concentrations of anti-atherogenic HDL cholesterol and HDL particles along with lower levels of atherogenic large very-low density lipoprotein (VLDL) particles, total and small LDL particles, and triglycerides compared to those without CFTR modulator therapy. ConclusionCFTR modulator therapy has a beneficial effect on dyslipidemia in CF. It remains to be seen if these positive changes translate into decreased CVD risk later in life given the increasing life expectancy in CF.

Clinical and molecular description of two cases of neonatal diabetes secondary to mutations in PDX1.

Pancreatic dysgenesis (PD) is a rare congenital disease, with less than 100 cases reported in the literature. In most cases, patients are asymptomatic and the diagnosis is made incidentally. In this report, we present the case of two brothers with a history of intrauterine growth retardation, low birth weight, hyperglycemia, and poor weight gain. The diagnosis of PD and neonatal diabetes mellitus was made by an interdisciplinary team composed of an endocrinologist, a gastroenterologist, and a geneticist. Once the diagnosis was made, treatment with an insulin pump, pancreatic enzyme replacement therapy, and supplementation with fat-soluble vitamins was decided. The use of the insulin infusion pump facilitated the outpatient treatment of both patients. Pancreatic dysgenesis is a relatively rare congenital anomaly; most of the time, patients are asymptomatic and are diagnosed incidentally. The diagnosis of pancreatic dysgenesis and neonatal diabetes mellitus should be made with an interdisciplinary team. Due to its flexibility, the use of an insulin infusion pump facilitated the management of these two patients.

1431-P: Exocrine Pancreatic Insufficiency Is Both a Risk Factor for and Comorbidity of Diabetes Mellitus

Introduction: Exocrine Pancreatic Insufficiency (EPI) is an uncommon but important disease of the exocrine pancreas. Its relationship to endocrine pancreas function and diabetes (DM) remains poorly characterized. To better understand this relationship, a retrospective chart review was performed in a large statewide multispecialty practice. Methods: A retrospective review of the entire 1.3 million patient-practice of Ochsner Health system in Louisiana was performed to cover the period of January 2017 to January 2020. All cases of documented EPI and patients on pancreatic enzyme replacement therapy (PERT) were identified and underwent individual chart review to identify etiologic factors and cardiometabolic, demographic, vital sign data, and clinical course information. Results: 677 EPI patients were identified with DM being the most prevalent etiologic risk factor (44.6% T2DM, 9.6% T1DM and 11.5% secondary DM). EPI patients without DM had a 10.9% prevalence of pre-DM, and 127 new DM cases developed over the observation period among EPI patients initially without DM with an 18.7% incidence rate. EPI patients, compared to the general DM population, were significantly younger with more diverse DM etiology. They also had greater LFT and serum lipase elevations. EPI patients had lower BMIs; 25.6 ± 7.5 vs 32.8 ± 46.9 kg/m2 with greater alcohol use. EPI patients also had better glycemic control (HBAC 6.83 ± 2.1 vs 7.2 ± 1.9) and triglycerides (125.7 ± 104.7 vs 140.6 ± 118.9) though other lipids were similar. Discussion and Conclusions: EPI, though uncommon, is both an important risk factor for onset of DM and comorbidity of diabetes. DM patients with EPI have distinctive etiologic, metabolic, and anthropometric features from DM patients in the general population. Further study of EPI patients to better understand predictors of onset of EPI in DM patients and DM onset in non-DM EPI patients are needed to guide evidence based screening. This would in turn enable early EPI recognition and management. Disclosure K.G.Romo: None. S.Shu: None. A.A.Noor: None. W.A.West: None. S.Bhamre: None. G.I.Uwaifo: None.

P297 Dual delivery microbial enzymatic product as alternative PERT for cystic fibrosis patients

Around 85% of Cystic Fibrosis (CF) patients have exocrine pancreatic insufficiency (EPI) and need supplementation with pancreatic enzyme replacement therapy (PERT). Most of them are unnecessarily overdosed with digestive enzymes (pancreatin) which can cause a painful complication called fibrosing colonopathy.