RESUMO
Objectives: Diabetic dyslipidaemia (DD) is characterised by hypertriglyceridaemia and elevated or normal levels of low-density lipoprotein cholesterol and decreased levels of high-density lipoprotein cholesterol with Type 2 diabetes mellitus. Statins and anti-diabetic medication are coprescribed for optimal control. Materials and Methods: The objective of the study was to compare the safety and efficacy of Saroglitazar 4-mg and Fenofibrate 200 mg in combination with low dose Atorvastatin (10 mg) in patients with DD. Run-in period of 4 weeks for life-style and diet modification followed by 12 weeks of treatment with saroglitazar or fenofibrate and low dose of atorvastatin was followed. Primary outcome of this study was an absolute change in serum triglyceride level at baseline and end of treatment period (12 weeks). Secondary outcome was changed from baseline lipid profile, fasting blood glucose and glycosylated haemoglobin (HbA1c) at the end of treatment period. Safety assessment was also done during the duration of study. Results: Forty patients of DD were randomly divided into two groups. One group received Saroglitazar 4 mg along with Atorvastatin 10 mg. Patients in second group received Fenofibrate 200 mg along with Atorvastatin 10 mg. Improvement in deranged lipid levels in both the groups was observed and this difference in improvement statistically was not found to be significant. We also observed that Saroglitazar significantly improves glycaemic profile by decreasing fasting blood sugar levels and HbA1c (P = 0.01, P < 0.01). Adverse events reported during this study were mild and none of the patients reported serious adverse events. Conclusion: Saroglitazar could be a potential drug to control both hyperglycaemia and dyslipidaemia in patients with DD.
RESUMO
Introduction: Type 2 diabetes mellitus is a commoncondition characterized by high blood sugar level. This riskgets inflated by lipid abnormalities additionally. Diabeticshave high risk of developing dyslipidemia (AtherogenicDiabetic Dyslipidemia-ADD) which is characterized by hightriglycerides and/or low HDL-C and/or small dense LDL-C.Study aimed to assess difference in mean Fasting plasmaglucose (FPG), Post prandial plasma glucose (PPPG), Lipidparameters [ triglycerides (TG), total cholesterol (TC), verylow density lipoprotein (VLDL), low density lipoprotein(LDL), high density lipoprotein (HDL) and non-HDL] beforeand after adding saroglitazar in patients of type 2 diabetes.Material and Methods: A total of 36 cases with DiabetesMellitus Type 2 aged between 18 and 65 years with their BMI>25kg/m2, HbA1c between 7 and 9% and total cholesterollevels >150mg/dl were enrolled. Their baseline glycemicand lipid parameters were measured and they were givenSaroglitazar 4mg every day for 3 months and their parameterswere checked again at the end of 3 months.Results: It was found that the mean Fasting plasma glucose(FPG), Post prandial plasma glucose (PPPG), Lipid parametersdecreased after 3 months of Saroglitazar therapy and thisdecrease was found to be statistically significant (P<0.001).Conclusion: Thus, addition of Saroglitazar to the drugregimen of the patients with Diabetic Dyslipidemia can bringabout significant improvement in the glycemic and lipidparameters with the added advantage of insignificant adverseeffects, thus proving beyond doubt the efficacy and safety ofthis drug in the treatment of Diabetic Dyslipidemia.
RESUMO
Diabetes is a chronic metabolic disorder with high mortality rate and with defects in multiple biological systems. Two major types of diabetes are recognized, type 1 and 2 with type 2 diabetes (T2D) being by far the more prevalent type. As diabetes affects multiple biological functions, the use of multiple drug classes having different mode of actions is required in order to optimize therapy in diabetic patients. Five major classes of oral antidiabetic agents (OHA) have traditionally been used for the management of patients with T2D. These include the sulphonylureas, meglitinides, biguanides, thiazolidinediones and the alpha-glucosidase inhibitors. Several newer classes of agents have also been introduced recently in the pharmacotherapy of T2D, including the incretin mimetics, the dipeptidy peptidase 4 (DPP-4) inhibitors, the sodium glucose co-transporter 2 (SGLT 2) inhibitors and more recently, the dual peroxisome proliferator-activated receptor (PPAR) agonists. Each of these agents has been shown in various experimental and clinical settings to be efficacious in T2D, but each is also associated with a number of adverse effects. Despite the vastarray of drugs introduced, metformin, a biguanide, largely remains the first choice mono therapy in T2D patients but several combination options are also available in poly pharmacy when mono therapy fails to produce the required glycemic control. The increasing number of drugs, together with numerous combination options in poly pharmacy, presents with the clinician an increasing complexity of therapeutic options. The likely pathogenetic mechanism of diabetes operating in the patient, as well as the mode of action, efficacy and safety of the drugs are some of the major considerations in the choice of any given agent or its combinations. This review therefore focuses on the mode of action, pharmacokinetics, indications, efficacy and adverse effects of the OHA used in T2D.