Repositioning Opportunities for Antidiabetic and Cardiovascular Drugs with Reference to Pharmacovigilance

Abstract

Background: Drug development is an expensive and time-consuming process, which could be reduced if the existing resources could be applied to identify a novel candidate for drug repositioning (also known as drug repurposing). In recent years drug repositioning has become a popular strategy as compared to traditional strategies for drug development. newlineAim: This study has been performed to find out drug repositioning opportunities for antidiabetic and cardiovascular drugs with reference to pharmacovigilance data. newlineMethod: The pharmacovigilance data for antidiabetic and cardiovascular drugs was retrieved from United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database for the duration from 1st January 2004 to 31st December 2018. On this retrieved data (drug-event pairs), signal management activity comprised of (1) signal detection, (2) signal validation and signal confirmation, and (3) signal prioritisation, analysis and assessment has been applied to identify a novel potential candidate for drug repositioning. Statistical parameters [i.e. Proportional Reporting Ratio (PRR), 95% Confidence Interval (CI) of PRR, Reporting Odds Ratio (ROR) and 95% CI of ROR] for selected drug-event pairs have been calculated to support the outcome of this study. Signal detection is a process for identification of signals using data from published literatures and relevant authenticated source in support of published data. For signal detection activity, drug of interest and event of interest were identified from FAERS. For signal validation and confirmation, drug-event pairs were quantitatively analysed from OpenVigil FDA Version 2.1. For signal prioritization, analysis and assessment the identified data were qualitatively analysed based on systematic review through published literature and understanding of pharmacological profile of selected drug of interest for drug reposition. newlineResults: Through quantitative and qualitative analysis of selected drug-event pairs, we found that aspirin,