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Comparison of Effectiveness and Safety of Add-on Therapy of Saroglitazar and Fenofibrate with Metformin in Indian Patients with Diabetic Dyslipidaemia. | LitMetric
Introduction : Diabetic dyslipidaemia poses a therapeutic challenge. New therapies have emerged in this patient subgroup to enhance outcome and improve compliance.Aim : The aim of this study was to compare the effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with diabetic dyslipidaemia.Materials And Methods : Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) and fenofibrate (160 mg/day) while group B patients received metformin (1000 mg/day) and saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and week 12 visits. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and on week 4, 8 and 12 visits.Results : TG and HbA1C levels decreased significantly at week 12 from their respective baseline values (p< 0.05) in both groups. FPG and PPPG levels significantly decreased at weeks 4, 8 and 12 compared to their pretreatment values (p< 0.05) in both groups. TG and HbA1C levels in group B decreased significantly compared to group A at week 12. FPG and PPPG levels in group B also decreased significantly compared to group A at every interval. Inter group analysis did not show any statistically significant change in body weight, LDL-C and HDL-C at week 12.Conclusion : Add on therapy of saroglitazar with metformin significantly decreased TG, HbA1C, FPG and PPPG levels compared to add on therapy of fenofibrate with metformin in Indian patients with diabetic dyslipidaemia.
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