Challenges and Opportunities for Diagnosing and Treating Exocrine Pancreatic Insufficiency (EPI): A Systematic Literature Review: 302

Introduction: EPI is associated with several conditions that contribute to high morbidity and economic burden for patients and payers. Limitations of current detection and screening techniques may delay or hinder treatment of EPI. To better understand challenges in diagnosis, as well as real-world diagnostic and treatment rates (i.e., those measured in clinical practice or in an observational setting rather than estimated rates), we systematically reviewed published research and guidelines for EPI. Methods: We searched MEDLINE- and Embase-indexed literature published from 2002 to 2012 and professional organizations for research related to diagnostic guidelines, and diagnosis and treatment rates. English-language articles reporting on EPI due to any etiology were included. Studies meeting all predefined inclusion criteria were abstracted and synthesized in our review. Results: Nineteen publications were included. Two guidelines (2010) from Australia and Brazil focused on a primary diagnosis of EPI. Recommendations outlined direct and indirect diagnostic tests available to clinicians but did not provide universally-accepted diagnostic criteria. No U.S.-based guidelines were identified. Fifteen studies evaluated direct and indirect diagnostic techniques. Direct tests measure pancreatic function, while several indirect tests measure pancreatic function or steatorrhea, a primary symptom of EPI. Current diagnostic tests have limitations, including low specificity or sensitivity, inability to distinguish between causes and symptoms of EPI, limited availability, and inconvenient or invasive procedures. The indirect test of fecal elastase-1 (FE-1) is the most widely-studied tool. FE-1 is useful for diagnosing severe EPI, but has low sensitivity for mild-to-moderate EPI. A single study reported diagnosis rates; this population-based study (2000-2002) in Germany observed that ˜11.5% of older adults screened during a general health exam were diagnosed with EPI. This prevalence rate is higher than older estimates, suggesting that EPI prevalence may be under-reported. Our review did not identify any studies on real-world treatment rates for EPI. Conclusion: The limitations of current diagnostic guidelines and tests demonstrate the need for improved and standardized diagnostic criteria for EPI. Real-world treatment rates remain unknown. Future research should contribute to the development of evidence-based diagnostic guidelines grounded in empirically-derived rates of diagnosis and treatment of EPI. Disclosure - AbbVie participated in conducting the research, reviewing literature, writing, reviewing, and approving of the publication. Evidera was paid by, and collaborated with, AbbVie to conduct the review and develop the abstract. This research was supported by an industry grant from this research was funded by AbbVie Inc., North Chicago.