Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone. (July 2014)

• Record Type: Journal Article
• Authors: Pareek, Anil; Chandurkar, Nitin; Thomas, Nihal; Viswanathan, Vijay; Deshpande, Alaka; Gupta, O.P.; Shah, Asha; Kakrani, Arjun; Bhandari, Sudhir; Thulasidharan, N.K.; Saboo, Banshi; Devaramani, Shashidhar; Vijaykumar, N.B.; Sharma, Shrikant; Agrawal, Navneet; Mahesh, M.; Kothari, Kunal
• Is Part Of: Current medical research and opinion. Volume 30:Number 7(2014:Jul.)
• Page Start: 1257
• Page End: 1266
• Publication Date: 2014-07
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2014.909393
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>To compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus (T2DM).</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>This double-blind study randomized 267 uncontrolled type 2 diabetes patients (HbA1c ≥7.5% and ≤11.5%), post 3 months' treatment with glimepiride/gliclazide and metformin, to additionally receive hydroxychloroquine 400 mg/day (<italic>n</italic> = 135) or pioglitazone 15 mg/day (<italic>n</italic> = 132) for 24 weeks. Efficacy was assessed by changes in HbA1c, fasting (FBG) and post-prandial (PPG) blood glucose at Week 12 and Week 24.</p> </sec> <sec id="ss3"> <title>Results:</title> <p>At Week 12 and Week 24, HbA1c, FBG and PPG significantly reduced from baseline in both groups. Mean reduction in glycemic parameters at Week 12 (HbA1c: −0.56% vs −0.72%, <italic>p</italic> = 0.394; FBG: −0.99 mmol/L vs −1.05 mmol/L, <italic>p</italic> = 0.878; PPG: −1.93 mmol/L vs −1.52 mmol/L, <italic>p</italic> = 0.423) and Week 24 (HbA1c: −0.87% vs −0.90%, <italic>p</italic> = 0.909; FBG: −0.79 mmol/L vs −1.02 mmol/L, <italic>p</italic> = 0.648; PPG: −1.77 mmol/L vs −1.36 mmol/L, <italic>p</italic> = 0.415) was not significantly different between the hydroxychloroquine and pioglitazone groups. Change in total cholesterol (TC) and LDL-C was significant in favor of hydroxychloroquine (TC: −0.37 mmol/L vs 0.03 mmol/L, <italic>p</italic> = 0.002; LDL-C: −0.23 mmol/L vs 0.09 mmol/L, <italic>p</italic> = 0.003). Triglycerides significantly reduced in both groups at Week 24. Mean HDL-C remained unchanged. Study treatments were well tolerated.</p> </sec> <sec id="ss4"> <title>Conclusion:</title> <p>With favorable effects on glycemic parameters and lipids, hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM.</p> </sec> <sec id="ss5"> <title>Limitations:</title> <p>The sample size for this study was small. However, based on the encouraging results of this proof-of-concept study, longer duration studies in larger population can be conducted to further confirm these findings.</p> </sec> <sec id="ss6"> <title>Trial registration details:</title> <p>Clinical Trial Registry–India URL: <ext-link ext-link-type="uri" xlink:href="http://ctri.nic.in" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">http://ctri.nic.in</ext-link>, Registration Number: CTRI/2009/091/001036.</p> </sec> </abstract>