Safety Signal Detection And Patient Profile Heterogeneity In Multiple Indication Drugs

Abstract

Spontaneous reporting systems (SRSs) gather reports of adverse drug reactions that a given patient experiences upon using a set of prescribed drugs. This allows for post-marketing detection of safety concerns that might have not been detected during the clinical trials. Whereas numerous papers have been published regarding drugs’ postmarketing safety evaluation, their subpopulations’ peculiarities have remained largely unexplored. This study aims to understand whether differences exist in the safety and demographic profiles between different indicated uses of drugs. To that end, demographic and safety signal analyses were performed on the integrated version of the SRSs implemented in ClarityVista. The disproportionality analysis was based on the Proportional Reporting Ratios (PRRs). The results show a presence of distinct safety and patient demography profiles between indications of the same drugs. This can be of particular importance for drugs whose prescription domain include diverse indications, such as repurposed drugs, ensuring that safety signals of one indication are not obscured by the influence of another. Moreover, this allows for more accurate safety estimation of pharmaceutical products which are intended for one indicated use of a drug.