Ahmed Ullah Mishuk, BPharm, MS

In the United States, PPIs are among the highest-selling classes of drugs, but their utilization patterns and safety profile evaluation among patient subgroups is limited. The overall objective of this research is to systematically and comprehensively assess the safety of post-marketing use of PPIs among the real-world population living in the United States. In this study, multiple population level datasets and medical literature will be used: In aim 1, a retrospective, serial cross-sectional analysis using the 2002-2015 Medical Expenditure Panel Survey will be conducted to assess the trends, expenditure, and factors affecting the use of PPIs in the United States population. In aim 2, FDA Adverse Events Reporting System data (2004-2018) will be used to detect safety signals of PPIs through disproportionality analysis and Medicare claims data (2013-2016) will be used to identify risk factors and high-risk populations associated with PPI-related AEs among new users of PPIs. Finally, a comprehensive systematic review and meta-analysis, consisting of different level of evidence, will characterize how the magnitude of specific risks associated with PPI-use compare across hierarchical evidence. Findings in distributions of PPI-use, factors and cost associated with PPI-use, and factors related to PPI-related AEs will provide a thorough assessment of PPI use among the United States population overtime, which in turn, will guide policymakers to improve the cost-effectiveness assessment and appropriate use of PPIs.