saroglitazar and Cardiovascular-Diseases

Topics: Cardiovascular Diseases; Humans; Phenylpropionates; Pyrroles; Randomized Controlled Trials as Topic

Topics: Cardiovascular Diseases; Humans; Phenylpropionates; Pyrroles; Randomized Controlled Trials as Topic

The incidence of cardiometabolic diseases is increasing because of an increase in the standard of living. Currently, clinical treatment strategies for cardiometabolic diseases mainly focus on maintaining glycemic and lipid profiles. The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of saroglitazar in patients with metabolic disease and provide evidence for clinical decision making.. We searched electronic databases (PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], and Google Scholar) for randomized controlled trials that examined saroglitazar for the treatment of patients with cardiometabolic disease. A total of seven randomized controlled trials were included for the qualitative and quantitative synthesis. Mean difference (MD) and risk ratio with a 95% confidence interval (CI) were applied for continuous and dichotomous data, respectively.. The overall effect of saroglitazar showed significant changes in triglycerides, total cholesterol, low-density lipoprotein, non-high-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, alkaline phosphatase, and gamma-glutamyl transferase levels [MD: - 40.50; 95% CI - 58.09 to - 22.92; p < 0.00001; I. Our study results conclude that the overall effect of saroglitazar was beneficial only in terms of lipid profiles and liver function parameters, whereas saroglitazar 4 mg showed a better therapeutic role in maintaining lipid and glycemic parameters in patients with cardiometabolic disease.

Topics: Blood Glucose; Cardiovascular Diseases; Humans; Lipoproteins, LDL; Randomized Controlled Trials as Topic; Triglycerides

Diabetes and dyslipidemia are commonly associated modifiable risk factors for cardiovascular diseases. Majority of patients with diabetes also suffer from dyslipidemia (diabetic dyslipidemia). Diabetic dyslipidemia is more atherogenic as it is commonly associated with high triglyceride (TG) levels, high proportion of small dense low-density lipoprotein cholesterol and low high-density lipoprotein cholesterol (HDL-C) level (atherogenic dyslipidemia). Currently used pharmacotherapies for the management of diabetes and dyslipidemia like thiazolidinediones (PPAR-γ agonist; for insulin resistance) and fibrates (PPAR-α agonist; for hypertriglyceridemia) have many limitations and side effects. Saroglitazar , a dual PPAR-α/γ agonists, is an emerging therapeutic option with its dual benefit on glycemic and lipid parameters.. This paper reviews the clinical development of saroglitazar for the management of diabetic dyslipidemia. The efficacy and safety profile of saroglitazar is reviewed in context to currently available therapy like pioglitazone for diabetes and fibrates for hypertriglyceridemia. In addition, this paper also reviews the association between diabetes and dyslipidemia and the role of TG in reducing cardiovascular events.. Saroglitazar, a dual PPAR-α/γ agonist, is a potential therapeutic option for the management of diabetic dyslipidemia. It has dual benefit of significant improvement in glycemic parameters (glycated hemoglobin and fasting blood glucose) and significant improvement in dyslipidemia (TGs, apolipoprotein B, non-HDL-C). The results of Phase III clinical trials indicate that saroglitazar is devoid of conventional side effects of fibrates and pioglitazone. Future clinical trials of saroglitazar will further establish its place in the management of diabetes, dyslipidemia and associated cardiovascular risk.

Topics: Animals; Atherosclerosis; Blood Glucose; Cardiovascular Diseases; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dyslipidemias; Glycated Hemoglobin; Humans; Lipids; Phenylpropionates; PPAR alpha; PPAR gamma; Pyrroles; Risk Factors

The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus.. In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model.. A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study.. Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015.

Topics: Biomarkers; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Double-Blind Method; Dyslipidemias; Glycated Hemoglobin; Humans; Hypoglycemic Agents; India; Lipids; Phenylpropionates; Pioglitazone; Prospective Studies; Pyrroles; Time Factors; Treatment Outcome

Cardiovascular risk reduction is an important issue in the management of patients with Type 2 diabetes mellitus. Peroxisome proliferator activated receptor (PPAR) agonists favourably influence glycaemic and lipid parameters in patients with Type 2 diabetes and a dual PPAR agonist is expected to have favourable effect on both parameters. In this study we have analyzed the effect of Saroglitazar, a novel dual PPAR alpha &gamma agonist, on glycaemic and lipid parameters in Indian patients with Type 2 diabetes. After a mean follow-up period of 14 weeks in 34 patients, treatment with Saroglitazar, in a dose of 4 mg daily, resulted in significant improvement in both glycaemic and lipid parameters. There were significant mean reductions of fasting plasma glucose (36.71 mg/dl; p = 0.0007), post-prandial plasma glucose (66.29 mg/dl; p = 0.0005), glycosylated haemoglobin (1.13%; p < 0.0001), total cholesterol (48.16 mg/dl; p < 0.0001), low- density lipoprotein cholesterol (24.04 mg/dl; p = 0.0048), triglyceride (192.78 mg/dl; p = 0.0001), non-high density lipoprotein cholesterol (48.72 mg/dl; p < 0.0001) and the ratio of triglyceride and high density lipoprotein cholesterol (5.30; p = 0.0006). There was no significant change in body weight, blood pressure, high-density lipoprotein cholesterol and serum creatinine.

Topics: Adult; Aged; Blood Glucose; Cardiovascular Diseases; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Follow-Up Studies; Glycated Hemoglobin; Humans; Hypoglycemic Agents; India; Male; Middle Aged; Phenylpropionates; PPAR alpha; PPAR gamma; Pyrroles; Treatment Outcome; Triglycerides