856-P: Long-Term Safety and Efficacy Evaluation of Hydroxychloroquine in T2D

Abstract

This prospective, multicentric, phase 4 study enrolled 747 T2D patients uncontrolled (A1c≥7) on Metformin+SU combination to receive add on HCQ 400 mg/day for 52 weeks. Primary outcome measure was, long term safety of HCQ evaluated in ITT population (n=747). Secondary outcomes were post treatment changes in glycemic, lipids and inflammatory parameters. Total of 191 AEs were reported in 111 patients, most were GI related (26.2%), mild in intensity (85%) and unlikely related (70%) to HCQ. Level 1 hypoglycemia was reported in 6.8% patients and mild NPDR in 11 patients. Of the 9 SAEs reported, 8 were unrelated and 1 (anemia) was probably related to HCQ. In mITTc population, the overall fall in A1c, FBG and PPG at week 12, 24 and 52 was significant from baseline. Additionally, a significant fall in TC, LDL-C, non-HDL-C was reported at week 24 and 52 from baseline. Patients were divided in two subgroups based on their baseline hsCRP levels (≤3 or ≥3). Of the 52% females enrolled, more than 60 % had high inflammatory load at baseline. There was significant fall in A1c, FBG, PPG, LDL-C, TC, and non-HDL-C at week 24 and 52 irrespective of baseline hsCRP. However, fall in A1C was significantly more at week 12 and 24 in patients with higher inflammatory load (hsCRP: ≥3) at baseline (p<0.0001). T2D is characterized by chronic low grade inflammation (meta-inflammation). HCQ has significantly reduced glycemic parameters with added benefits on lipids Disclosure A.Pareek: None. N.Chandurkar: None. K.B.Naidu: None. P.Dicholkar: None.