Abstract

PREDICTION OF NOVEL THERAPEUTIC INDICATION FOR ROSIGLITAZONE USING ITS REPORTED CLINICAL SIDEEFFECTS: DRUG REPOSITIONING BY PHARMACOVIGILANCE APPROACH

Shital Panchal* and Mrugank Parmar

Abstract

Drug repositioning by Pharmacovigilance approach is primary objective of this study. We consider rosiglitazone as target molecule for this pilot scale study. Rosiglitazone is an anti-diabetic drug of thiazolidinedione class. It works as an insulin sensitizer, by binding to the peroxisome proliferator activated receptor (PPAR) gamma in fat cells and making the cells more responsive to insulin. Rosiglitazone has been selected as target molecule because most recently on 16 December 2015 in interest of its safety, United States Food and Drug Administration (USFDA) announced to eliminate the risk evaluation mitigation strategy for rosiglitazone and confirmed it as one of the safe and effective treatment for diabetes. For this study we retrieved total 6,884 adverse drug reaction cases of rosiglitazone from drug safety database of USFDA covering the duration from 2010 to 2015. With respect to our study objective, we analysed 5,844 cases of rosiglitazone reported with non-serious side effects thoroughly using its phenotypic parameters (pharmacologic mechanism of action and safety) and proposed two novel therapeutic indications for rosiglitazone use either in Alzheimer’s disease or in hypertension. Further studies covering the data for larger duration and same objective may adjuvant our results for the reposition of rosiglitazone by Pharmacovigilance approach.

Keywords: drug reposition; rosiglitazone; anti-diabetic; Alzheimer's disease; hypertension.