Efficacy and safety of fixed dose combination of atorvastatin and hydroxychloroquine: a randomized, double-blind comparison with atorvastatin alone among Indian patients with dyslipidemia.

OBJECTIVE: To evaluate the efficacy and safety of atorvastatin + hydroxychloroquine fixed-dose combination tablets in comparison with atorvastatin alone in treatment of dyslipidemia. METHODS: This double-blind, randomized, out-patient study was conducted in 328 patients with primary dyslipidemia having low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dL (3.37 mmol/L) to ≤ 250 mg/dL (6.48 mmol/L) and triglycerides ≤ 400 mg/dL (4.52 mmol/L). Eligible patients were randomized to receive either atorvastatin 10 mg (n = 167) or atorvastatin 10 mg + hydroxychloroquine 200 mg (n = 161) for 24 weeks. CLINICAL TRIAL REGISTRATION: CTRI/2010/091/006138. MAIN OUTCOME MEASURES: To compare percentage change in LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12 and Week 24 between groups. To compare mean change in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), high-sensitivity C-reactive protein (Hs-CRP), and percentage of patients achieving lipid goals at Week 12 and Week 24. RESULTS: At Week 24, percentage reduction in LDL-C (-32.52 [-36.13 to -28.91] vs -39.54 [-43.25 to -35.83]; p = 0.008), TC (-24.41 [-27.10 to -21.72] vs -29.30 [-32.07 to -26.54]; p = 0.013), and non-HDL-C (-30.37 [-33.71 to -27.04] vs -36.76 [-40.18 to -33.33]; p = 0.009) was significantly greater in combination treated patients. Both the treatments showed a significant reduction in triglycerides at Week 24 from baseline, however, this reduction was not statistically significantly different between treatment groups. No significant change in HDL-C was observed in patients from both the treatment groups. At Week 24, change in HbA1c (0.22 [0.07 to 0.37] vs -0.13 [-0.28 to 0.03]; p = 0.002) and FBG was also statistically significant in favor of combination therapy (0.37 [0.07 to 0.67] vs -0.29 [-0.59 to 0.03]; p = 0.003), whereas no statistically significant difference was observed in change in Hs-CRP (p = 0.310). Significantly more patients from the combination group achieved LDL-C and TC goals. Exploratory analysis in patients with pre-diabetes showed development of diabetes in 8 patients (15.09%) from the monotherapy group and 1 patient (1.96%) from the combination group (p = 0.034). Study medications were generally safe and well tolerated. CONCLUSION: Based on study results and widely reported pleiotropic benefits, hydroxychloroquine could emerge as a potential drug for combination with statins for treatment of dyslipidemia. Long duration studies with larger sample sizes are required to further explore the role of hydroxychloroquine as adjunct to statins in reducing risk of cardiovascular events and prevention of statin-induced diabetes.

Consensus guidelines for glycemic monitoring in type 1/type 2 & GDM.

Stringent monitoring of blood glucose in diabetes plays an important role as the treatment of the disease itself. Blood glucose monitoring (BGM) strategies such as measurement of Hb1Ac, Self-Monitoring of Blood Glucose (SMBG) and Continuous Glucose Monitoring (CGM) plays a vital role in achieving the important goal of preventing long term complications of diabetes. Although the use of BGM is recommended by various international guidelines in T1DM and T2DM, there is no consensus on the utility of BGM in India. So, there is a need to develop a guidance for uniform monitoring mechanism among the care givers taking into account the variations and challenges that are unique to Indian population. A committee was established that comprised of physicians, researchers and other healthcare professionals having expertise in diabetes treatment to oversee the formulation of guidelines on different monitoring and treatment aspects of diabetes. Extensive literature searches were conducted to identify and analyze the evidence available on BGM. An initial draft of BGM guidelines was presented to core members who discussed the subject matter and presented their opinion. This was then taken to wider expert audience to invite their comments that were incorporated in the initial draft. The first compilation was presented at a conference attended by nearly 200 experts. Again, their opinion was sought and the next version was prepared which was sent to core committee members for the final inputs. The Indian consensus guideline on BGM using Hb1Ac, SMBG and CGM as the primary tools was then finalized.