* Proportion of the entire study population
Mo1319 IDENTIFYING MALNUTRITION AND ITS CONSEQUENCES IN CHRONIC PANCREATITIS May Min, Boskey Patel, Samuel Han, Lisa Bocelli, Joan Kheder, Wahid Wassef Introduction Exocrine pancreatic insufficiency (EPI) is a potential complication of chronic pancreatitis that can lead to maldigestion, malabsorption, steatorrhea, weight loss, and malnutrition. As a result, patients with EPI are at increased risk for fat-soluble vitamin deficiencies and metabolic bone disease (osteoporosis and osteopenia). EPI is often underrecognized due to challenges with its diagnosis, identifying high-risk patients, and optimizing management with pancreatic enzyme replacement therapy (PERT). Currently, there are few studies examining the manifestations of and risk factors for EPI. Methods 91 patients with chronic pancreatitis diagnosed previously with endoscopic ultrasound (EUS) were identified and assessed for symptoms of EPI (bloating, steatorrhea, and weight loss), qualitative fecal fat assays, fat-soluble vitamin levels, DEXA scan T-scores, treatment with PERT, and chronic pancreatitis severity based on EUS. Patients were also screened with the Malnutrition Universal Screening Test (MUST) which is a validated five-step screening tool to identify adults who are malnourished or at risk for malnutrition. Results 86.8% (79/91) of patients were diagnosed with EPI based on clinical symptoms and/or positive qualitative fecal fat assays. A large proportion of patients had fat-soluble vitamin deficiencies, including 35.2% (19/ 54) with vitamin A deficiency, 62.5% (55/88) with vitamin D deficiency, and 17.7% (9/51) with vitamin E deficiency. Interestingly, 84.2% (16/19) of patients with vitamin A deficiency, 89.1% (49/55) with vitamin D deficiency, and 77.8% (7/9) with vitamin E deficiency were already being treated for EPI with PERT. 22.2% (10/45) of patients were diagnosed with osteoporosis and 68.9% (31/45) had either osteopenia or osteoporosis. 31.5% (28/89) of patients were found to be at risk for malnutrition based on the MUST, and a MUST score ≥1 (medium-high risk) was associated with an increased risk for osteopenia and osteoporosis on Fisher's exact test (p=0.0037). Positive EPI symptoms (bloating, steatorrhea, and/or weight loss) was associated with increased risk for vitamin A deficiency (p=0.0383), vitamin D deficiency (p=0.0001), osteoporosis (p=0.0165), and a MUST score ≥1 (p=0.0013). There was no significant correlation between chronic pancreatitis severity on EUS and vitamin A, D, or E levels. Conclusion EPI is associated with a high incidence of fat-soluble vitamin deficiencies, osteopenia, and osteoporosis. These sequelae are often underrecognized due to the lack of effective screening tools to identify chronic pancreatitis patients who are at risk for malnutrition. Patients who are at risk for nutritional deficiencies may be identified using the MUST and a thorough clinical history for the symptoms of EPI. Further studies are needed to validate these methods.
Figure 2. Baseline glucose homeostasis in patients with and without dysmotility symptoms
Mo1318 ORAL PANCREATIC ENZYME REPLACEMENT THERAPY (PERT) IN CHRONIC PANCREATITIS (CP) IS INFREQUENT AND OFTEN SUBOPTIMAL: A NATIONAL LEVEL ANALYSIS Chris Forsmark, Gong Tang, Hongzhi Xu, Dhiraj Yadav Background: Exocrine Pancreatic Insufficiency (EPI) is frequently seen in CP patients. Oral PERT is highly effective in treating EPI. However, survey data suggests that patients receiving oral PERT are vastly under-dosed. No community or population level studies of oral PERT use are available in the US. We hypothesized that oral PERT use is infrequent and suboptimal in CP patients. Methods: The PharMetrics Patient-Centric Legacy database consisting of all medical and pharmacy claims for individuals enrolled in over 80 health plans in the US was used. Among 48.67 million enrollees with ≥12 months of continuous enrollment from 2001-2013, we identified 37,061 patients who received at least one non-ancillary claim for a primary diagnosis of CP (ICD-9: 577.0). In these subjects, we determined the details of oral PERT use, and potential determinants of oral PERT use - demographic factors, alcohol and tobacco abuse, Charlson comorbidity index, region of the country, enrollment duration, performance of tests to assess EPI, associated diagnosis of diabetes, osteoporosis or osteopenia, fractures, cystic fibrosis, and pancreatic surgery. Appropriate PERT use was defined as a daily dose of > 120,000 lipase units/day (> 40,000/meal). Results: Of 37,061 patients, 49% were male, the mean age at the time of index CP claim was 51.2±15.2 years, and the median duration of enrollment, total and after CP diagnosis, was 33 months (IQR 31, 78) and 23 months (11, 45) respectively. A primary pancreatitis-related diagnosis (acute or chronic pancreatitis or pseudocyst) on at least one more occasion at any other time, or at least 3 months before or after the index claim, was present in 82% and 54% of patients. PERT was prescribed in 11,265/37,061 patients (30.4%). Table 1 shows the prevalence of relevant and significant predictors of oral PERT use - among these important ones include diabetes,
Mo1320 THE BURDEN OF CHRONIC PANCREATITIS IN THE UNITED STATES POPULATION Aynur Unalp-Arida, Constance E. Ruhl Chronic pancreatitis, as defined by signs and symptoms of a fibro-inflammatory process with exocrine and endocrine dysfunction, is thought to be less of a public health burden than acute pancreatitis, but nonetheless leads to significant morbidity and mortality in the United States with an overall estimated cost of $150 million in 2012 [Peery AF et al. Gastroenterol 2015;149:1731]. Approximately 10% of patients with acute pancreatitis may have a recurrence and may develop chronic pancreatitis over time with estimated incidence and prevalence rates of 4 and 42 per 100,000 population, respectively. We used national databases to expand on earlier findings and investigate current trends in the chronic pancreatitis burden in the United States. Methods: The National Ambulatory and Hospital Ambulatory Medical Care Surveys, Nationwide Inpatient Sample, and Vital Statistics of the U.S. databases were used to estimate medical care and mortality with a primary or other diagnosis of
S-677
AGA Abstracts
AGA Abstracts
prior pancreatic surgery, performance of any testing for EPI, and markers of bone health (osteoporosis, osteopenia or fracture). The median duration of oral PERT use was 4 months (1.5-13), which reflected a median of 9% (1.4-29%) of the enrollment period. PERT dosage was appropriate in only 3066/11,265 (27% patients) who received oral PERT. The median daily dose of PERT was 60,000 lipase units (17,000, 117,000). Conclusions: Oral PERT is used in approximately one-third of patients with a CP diagnosis. Several patient and diseaserelated factors determine PERT use. Most patients receiving PERT are under dosed, and only one-quarter receive minimally appropriate dosing. Improved awareness of appropriate use and dosing of oral PERT is important to prevent EPI-related complications in CP patients. Table 1:Predictors of oral PERT use in CP patients
AGA Abstracts
chronic pancreatitis. Rates were age-adjusted and shown per 100,000 population for the most recent year of national data available. Results: Chronic pancreatitis contributed to 208,000 ambulatory visits, 155,000 hospital discharges, and 1,000 deaths. Ambulatory visit rates with a chronic pancreatitis diagnosis were higher among men, African Americans, and non-Hispanics compared with women, whites, and Hispanics, respectively. The ambulatory visit rate rose by a quarter (50 to 64) from 1992 to 2012. Hospital discharge rates in 2013 were also increased among men compared with women (53 vs. 41), African Americans compared with whites (86 vs. 43), and non-Hispanics compared with Hispanics (51 vs. 29). The hospital discharge rate rose overall by 100% (23 to 47) from 1993 to 2013 and among gender and racial-ethnic groups (Figure 1). Similar to medical care rates, mortality rates in 2014 were higher among men compared with women (0.44 vs. 0.27), African Americans compared with whites (0.53 vs. 0.34), and non-Hispanics compared with Hispanics (0.37 vs. 0.18). In contrast to medical care rates, the mortality rate decreased among the overall population by 15% (0.41 to 0.35) from 1993 to 2014 as the result of declines among men and African Americans (Figure 2). Conclusions: Chronic pancreatitis is a common contributor to hospital stays and may shorten life expectancy. Significant disparities in hospitalization and mortality rates exist among patients with chronic pancreatitis, with a higher burden among men and African Americans and a lower burden among Hispanics.
µg×h/mL for fND (p=0.054). For 2 patients with CP using PERT and the patient post pancreatectomy, AUC0-8h was 283.2+173.2 µg×h/mL for PfND versus 189.7+142.9 µg×h/ mL for fND (p=0.035). Conclusion: Consumption of absorbable fats delivered as free fatty acids and monoglycerides, following contact with iLipase was well tolerated and resulted in a significant increase in absorption of critical omega-3 fatty acids (DHA/EPA). Use of this iLipase complex could be used with ND and EF to increase absorption of fat in patients with chronic pancreatitis or post pancreatectomy who have EPI.
Mo1322 PREDICTORS OF POSITIVE SECRETIN PANCREATIC FUNCTION TESTING: RESULTS OF A TWENTY YEAR STUDY Darshan J. Kothari, Gyanprakash A. Ketwaroo, Steven D. Freedman, Sunil Sheth Background and Aims: Chronic pancreatitis (CP) is characterized by progressive inflammation and fibrosis resulting in irreversible pancreatic damage. Secretin pancreatic function testing (sPFT) is often used in the diagnosis of early CP when other diagnostic modalities are normal. We sought to determine the effect of established risk factors for CP on the outcome of sPFT results in patients undergoing work-up for suspected CP. Methods: We completed a retrospective review of patients who underwent sPFT for suspected CP between January 1995 and December 2014 at a tertiary referral center. A positive test was defined as a peak bicarbonate concentration less than 80mEq/L. We compared 1) peak bicarbonate concentrations between groups and 2) completed univariate and multivariate analyses to determine associations between risk factors and positive sPFT results. Results: One hundred sixty-two patients underwent sPFT during the study period of which 43 patients had positive sPFT results (i.e. peak bicarbonate concentration < 80mEq/L). There were significant differences in peak bicarbonate concentrations in patients with and without recurrent acute pancreatitis (RAP) (51.2 mEq/L vs. 66.5 mEq/L, p<0.01) and in patients with local complications from acute pancreatitis (AP) (34.3 mEq/L vs. 66.1 mEq/L, p<0.01). The bicarbonate concentration in patients with and without other risk factors such as gender, tobacco use, alcohol use, diabetes, and family history of pancreatitis were not significantly different (Table 1). Female gender, a history of AP, and a history of RAP were associated with positive sPFT results on univariate analysis (p≤0.05), whereas chronic alcohol use, tobacco use, diabetes, family history of AP and multiple risk factors were not associated with positive sPFT results (Table 2). On multivariate analysis, gender and RAP remained significant (OR 3.9, 95% CI 1.447 - 10.49, p < 0.01 and OR 6.9, 95% CI 1.751 - 27.22, p < 0.01, respectively). Conclusions: Our study demonstrates that female gender, history of AP, RAP, and AP with local complications is associated with positive sPFT results or lower peak bicarbonate concentration. However other risk factors for CP do not impact the results of sPFT. Comparisons of peak bicarbonate concentrations between groups
Mo1321 DEVELOPMENT OF AN EX VIVO PANCREAS USING A LIPASE-BEAD COMPLEX: IMPROVING BIOAVAILABILITY OF FAT FROM ENTERAL FORMULAS AND NUTRITIONAL DRINKS IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS OR PANCREATECTOMY Russell Clayton, Danica Grujic, Steven D. Freedman
Univariate analysis: Association between risk factor and positive sPFT test
Introduction: Exocrine pancreatic insufficiency (EPI) is a common complication of chronic pancreatitis or pancreatectomy. Patients with EPI are at risk for fat malabsorption, resulting in reduced caloric intake, fatty acid deficiencies, and symptoms of malabsorption such as steatorrhea, pain, and bloating. These patients take pancreatic enzyme replacement therapy with meals and snacks for nutrient absorption, but the use of these products in conjunction with enteral formulas and nutritional drinks (ND) has not been fully demonstrated to be safe or effective. The enzyme lipase covalently bound to inert beads (iLipaseTM; Alcresta Therapeutics) hydrolyzes fat in enteral formulas and ND into their absorbable form (free fatty acids, monoglycerides) when the liquid comes in contact with the lipase-bead complex. The purpose of this study was to evaluate tolerability and fat absorption in patients with chronic pancreatitis or post pancreatectomy who consumed a fortified ND (fND) exposed to the lipase-bead complex. Methods: Patients with CP or post pancreatectomy were enrolled in a double blind cross over study and randomized to receive 240 mL of a ND (Boost® Original; NestleHealthScience; 4 g fat) fortified with 10 mL of algae oil (Algae Omega; Nordic® Naturals; 1.3 g EPA & 2.3 g DHA) either as is (fND) or after fat hydrolysis (PfND). Fat hydrolysis was performed by placing a mesh bag with 2 g of the iLipase into the drink and shaking for 10 min. After a 7-day washout period, patients crossed over to the alternate ND. Plasma samples were collected just prior to and 1, 2.5, 3.5, 5, 6.5, and 8 hours after drink consumption on both days. Plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) were determined using ultra high performance liquid chromatography. Plasma DHA+EPA concentrations were plotted over time to analyze bioavailability of DHA+EPA expressed as area under the curve (AUC) for PfND versus fND. Results: One patient post pancreatectomy and 5 patients with chronic pancreatitis enrolled in the study. Mean age was 42.3+16.9 years, and all were female. Two of the patients with CP had been using PERT prior to the study. Both the fND and PfND were well tolerated. For all 6 patients, mean AUC 0-8h was 421.5+222.6 µg×h/mL for PfND vs. 354.9+232.4
AGA Abstracts
Mo1323 A COMPARISON OF SMOKERS WITH NON-SMOKERS IN A CHRONIC PANCREATITIS POPULATION Samuel Han, Boskey Patel, May Min, Joan Kheder, Lisa Bocelli, Wahid Wassef Background: Smoking has been found to be an independent risk factor for the development of chronic pancreatitis and is known to accelerate disease progression. Population studies have found a large proportion of chronic pancreatitis patients to be smokers and this study aims to compare smokers and non-smokers with this disease to evaluate the holistic impact
S-678