Real-Life Investigation of Effectiveness and Tolerability of Hydroxychloroquine in Type 2 Diabetes Mellitus Patients in India

Aim: With the increasing incidence of type 2 diabetes mellitus (T2DM) in India (approximately 72 million affected), there is a growing concern and a need for newer, durable and cheaper therapies. Hydroxychloroquine (HCQ), a common anti-malarial also prescribed in rheumatic disease is associated with increased insulin sensitivity and improved glucose tolerance in these patients, with/without diabetes. As a speciality care provider, we initiated an enquiry into the effectiveness and tolerability of HCQ in T2DM patients, uncontrolled on metformin and sulfonylurea (SU) by undertaking this open-label, prospective study at our center. Methods: A total of 15 T2DM patients, aged between 43-59 years and unresponsive to metformin and SU were included and prescribed an add-on therapy of HCQ at 400 mg once daily for 24 weeks. Change in glycemic and lipid parameters was evaluated at 0, 12 and 24 weeks. Results: At the end of 24 weeks, there were clinically relevant decreases of 18% and 0.88% in mean fasting plasma glucose and HbA1c, respectively. The total cholesterol, triglycerides, low-density lipoprotein cholesterol and very low-density lipoprotein cholesterol decreased by 13.24%, 19.7%, 13.31% and 26.94% respectively, considered clinically meaningful with no patients discontinuing due to any adverse effects. Discussion: Patients of T2DM, uncontrolled on metformin and SU, often require a third drug/insulin for further treatment management. These results clearly demonstrate the benefits and tolerability of HCQ in Indian T2DM patients over 24 weeks with glycemic and lipid advantages. Although the sample size of the study was small, the encouraging results pave way for larger and longer duration, studies with HCQ. Conclusion: Based on this investigator-initiated prospective study, HCQ offers a safe, efficacious and cheaper alternative to T2DM patients, when uncontrolled on metformin and SU, particularly in limited resource countries, including India. Disclosure M.S. Chawla: Speaker9s Bureau; Self; IPCA Laboratories, Eli Lilly and Company, Novo Nordisk A/S, MSD Pharmaceutical Pvt. Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. Speaker9s Bureau; Spouse/Partner; Sanofi. P.M. Chawla: Speaker9s Bureau; Self; Sanofi. Speaker9s Bureau; Spouse/Partner; Eli Lilly and Company, IPCA LABORATORIES, Novo Nordisk A/S, MSD PHARMACEUTICALS PVT. LTD., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. P. Gupta: None.