Original Research Article
Year: 2019 | Month: November | Volume: 6 | Issue: 11 | Pages: 218-224
Efficacy and Safety of Hydroxychloroquine as an Add-On Therapy in Indian Patients with Type 2 Diabetes Mellitus Inadequately Controlled With Two Oral Drug Combination and Basal Insulin: A 72 Week Observational Trial
Dr. Arjun Baidya1, Dr. S. R. Pattanaik2, Dr. Anand Shankar3, Dr. Rishad Ahmed4, Dr. Netrananda Dora5, Dr. SaritaBehera6
1Associate Professor, Department of Endocrinology, NRS Medical College & Hospital, Kolkata,
2Associate Professor, Department of Endocrinology, MKCG Medical College, Berhampur,
3Shankar Diabetes Care Center, Patna,
4Associate Professor, Dept. of Medicine, KPC Medical College & Hospital, Kolkata,
5Diabetologist, Sambalpur,
6Endocrinologist, Cuttack
Corresponding Author: Dr. S. R. Pattanaik
ABSTRACT
Aim: Patients who were inadequately controlled with multi drug along with exogenous insulin needs an additional drug to control their sugar level. It is always in need to opt for an economic anti diabetic drug which have long lasting efficacy with added benefits. The main objective of this study to evaluate long term efficacy and safety of Hydroxychloroquine as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with two oral drug combination and basal insulin.
Materials and methods: In this multicenter observational trial, 498 T2DM patients (male: 50.9%; age: 50.8 ± 8.3 years; time from T2DM diagnosis: 2.6 ± 1.2 years; baseline HbA1c: 8.1 ± 0.9%) with inadequate glycemic control on diet, exercise and combination of metformin and sulfonylurea were assigned to once daily treatment with hydroxychloroquine 400 mg. HbA1c (%) and, fasting plasma glucose levels (FPG) (mg/dL) and post prandial plasma glucose levels (PPG)(mg/dl) along with HsCRP and Serum creatinine was calculated at baseline, at 24 week, 48 weeks and 72 week.
Result: After addition of hydroxychloroquine 400 mg there was sustain reduction in glycemic parameters which was maintain even upto 72 weeks (p>0.001)(Table 2). In first 24th weeks HbA1c was reduced by 0.9±0.2, which was 0.4±0.5 at 48th week and 0.4± 0.1 at 72nd week. There were significant reduction in FPG and PPG after 72 week study which was -74±26 mg/dl (p> 0.001) and -145± 39 mg/dl (p> 0.001) respectively from baseline. It has been also found that there was frequent drastic reduction in insulin dose. There were 22% reduction by 24th week from baseline which was further reduced to 32% at 48 week and finally further 26% reduction of daily insulin dose at the end of 72 weeks. Apart of significant reduction in glycemic parameters, hydroxychloroquine also reduced inflammatory load and hs-CRP was reduced to 0.7 ± 0.3 mg/dl from 2.7 ± 0.8 mg/dl at the end of 72 weeks. Serum creatinine was unchanged over the entire treatment period. here was no report of withdrawals or treatment- emergent adverse events related to the study medications, during the treatment phase. Not a single eye has developed retinopathy of any grade.
Conclusion: The results confirmed the long term clinical benefit of a daily hydroxychloroquine 400 mg mg regimen in the Indian population and significantly reduces the dose of daily Insulin.
Key words: Hydroxychloroquine, T2DM, Insulin, longterm efficacy.
[PDF Full Text]