1167-P: Safety and Efficacy of 52 Weeks' Therapy with Hydroxychloroquine (HCQ)—First Anti-inflammatory Drug Approved in India for T2D

Abstract

Introduction: This phase 4 study enrolled 600 T2D patients uncontrolled (A1c≥7%) on metformin+SU combination to receive add-on HCQ 400mg for 52 weeks (405 patients have completed 24 weeks and 234 have completed 52 weeks of study till date). Effect on glycemic, lipid and inflammatory parameters was assessed. Results: Efficacy was assessed in 234 patients completing 52 weeks of study. Patients were divided based on baseline hsCRP (≤3 and >3 mg/L). Enrolled population had more females and they had higher inflammatory load. HCQ significantly reduced glycemic, lipid and inflammatory parameters; with greater reduction in higher inflammatory load group. Similar effect is seen in 405 patients completing 24 weeks of study. Of the 140 AEs, most were GI related (25%), mild in intensity (84%) and unlikely related to HCQ (66%). Ten patients reported hypoglycemia; all were Level 1 as per ADA criteria. Eight NPDR cases were reported, all were mild and 7 were unlikely related to HCQ. Of the 6 SAEs reported, 5 were not related to HCQ. Causality was assessed by study investigators. T2D is characterized by chronic, low-grade inflammation, referred to as metaflammation. HCQ significantly reduced A1c (0.91%) and other glycemic parameters (comparable to other OHAs), with added benefits on lipid and inflammatory markers. Conclusion: T2D patients have high inflammatory load and HCQ could be effective and well-tolerated option. Disclosure A. Pareek: Employee; Self; Ipca Laboratories Ltd. R.T. Mehta: Employee; Self; Ipca Laboratories Ltd. S. Dharmadhikari: Employee; Self; Ipca Laboratories Ltd. K.B. Naidu: Employee; Self; Ipca Laboratories Ltd. Funding Ipca Laboratories Limited