Real-world data is important in providing evidence of treatment effectiveness in clinical practice. This real-world analysis included 1523 patients of T2D uncontrolled (A1c≥7%) on metformin-SU combination to additionally receive HCQ 400 mg/day for 24 weeks. Mean age of patients was 51.3 years and 53.25% were males. Of the 1523 enrolled patients, 1297 patients who completed 24 weeks of therapy were analyzed for effectiveness. Treatment with HCQ resulted in significant reduction in A1c (change from baseline at Week 12 and 24 was 1.10% and -1.41%, respectively; p<0.0001) and other glycemic and lipid parameters. At Week 24, 81% and 62% of patients reported a fall of ≥0.5% and ≥1% in A1c, respectively. Target A1c of <7% and <8% was achieved by 34% and 73% of patients, respectively at Week 24. Overall, HCQ was well tolerated. Majority of the 148 AEs were GI related (25%), mild in intensity (85%) and unlikely related (66%) to HCQ. Ten patients reported hypoglycemia; all were ADA Level 1. Nine NPDR cases were reported, all were mild and 8 were unlikely related to HCQ. Of 8 SAEs reported, 7 were not related to HCQ. Causality was assessed by investigator. Low-grade inflammation is a common feature in T2D. HCQ, an anti-inflammatory agent, significantly improved glycemic profile (comparable to other OHAs) with added benefits on lipids. Thus, HCQ could be an effective and well-tolerated therapeutic option for treatment of T2D.
A. Pareek: Employee; Self; Ipca Laboratories. S. Dharmadhikari: Employee; Self; Ipca Laboratories. R.T. Mehta: Employee; Self; Ipca Laboratories. K.B. Naidu: Employee; Self; Ipca Laboratories.
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