DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20172248

A randomized comparative study of efficacy and safety of saroglitazar with fenofibrate in diabetic dyslipidemic patients on metformin and glimeperide

Syed Mohsin Ahmed, Momin Mohd. Abdul Mujeeb

Abstract


Background: This study was conducted to compare the efficacy and safety of saroglitazar with fenofibrate in Indian diabetic dyslipidemic patients who were on Metformin and Glimepiride.

Methods: Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) + Glimepiride (4 mg/day) with fenofibrate (160 mg/day), while group B patients received metformin (1000 mg/day) + Glimepiride (4 mg/day) with saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and at 12 weeks. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and at 4, 8 and 12 weeks.

Results: There was a significant reduction in TG and HbA1C levels at 12 weeks from the baseline value (p=0.001) in both groups. However, there was no significant reduction in TG between the groups at 12 weeks but HbA1C levels in group B decreased significantly compared to group A at 12 weeks. Also, there was a significant reduction in FPG and PPPG levels at 4, 8 and 12 weeks in both groups from their baseline values (p=0.001). The reduction in FPG and PPPG levels in group B was statistically significantly compared to group A at every interval. There was statistically significant change in LDL-C and HDL-C at 12 weeks from baseline in both the groups. Also, there was significant rise in HDL-C in group B when compared to group A.

Conclusions: Group B patients on saroglitazar with metformin and Glimepiride showed a significant reduction in HbA1C, FPG and PPG levels compared to group A patients on fenofibrate with metformin and Glimepiride.


Keywords


Diabetes mellitus, Diabetic dyslipidaemia, Fenofibrate, Saroglitazar

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References


Joshi SR, Parikh RM. India - diabetes capital of the world: now heading towards hypertension. J Assoc Physicians India. 2007;55:323-4.

Kumar A, Goel MK, Jain RB, Khanna P, Chaudhary V. India towards diabetes control: Key issues. Australas Med J. 2013;6(10):524-31.

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes-estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(3):1047-53.

Whiting, Guariguata L, Weil C, Shawj. IDF Diabetes atlas: Global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94:311-21.

Muacevic-Katanec D, Reiner Z. Diabetic dyslipidaemia or diabetes lipidus? Expert Rev Cardiovasc Ther. 2011;9:341-48.

Wu L, Parhofer KG. Diabetic dyslipidaemia. Metabolism clinical and experimental. 2014;63:1469-79.

Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, et al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American diabetes association and the American college of cardiology foundation. Diabetes Care. 2008;31(4):811-22.

Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366(9500):1849-61.

Rubenstrunk A, Hanf R, Hum DW, Fruchart JC, Staels B. Safety issues and prospects for future generations of PPAR modulators. Biochim Biophys Acta. 2007;1771(8):1065-81.

Seber S, Ucak S, Basat O, Altuntas Y. The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients. Diabetes Res Clin Pract. 2006;71(1):52-8.

Agrawal R. The first approved agent in the Glitazar's Class: Saroglitazar. Curr Drug Targets. 2014;15:151-5.

Aggarwal AS. India's answer to diabetic dyslipidaemia. Int J Pharmacol and Clin Sci. 2014;3:7-14.

Pai V, Paneerselvam A, Mukhopadhyay S, Bhansali A, Kamath D. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidaemia (PRESS V). J Diabetes Sci Technol. 2014;8:132-41.

Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of Saroglitazar 2 and 4 mg compared with placebo in type 2 diabetes mellitus patients having hypertriglyceridaemia not controlled with atorvastatin therapy (PRESS VI). Diabetes Technol Ther. 2014;16:63-71.