Saroglitazar Reduces Predictor Lipid Biomarkers Of Cardiovascular Diseases

Krishnappa, Manjunath; Shah, Meena; Parmar, Krupi; Joshi, Sunil; Maroo, Sanjay; Parmar, Deven

doi:10.1016/j.atherosclerosis.2019.06.104

Cited by 2 publications

(3 citation statements)

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“…Likewise, saroglitazar 2 mg and 4 mg significantly reduced non HDL/HDL ratio and atherogenic index of plasma at week 12 and week 24 compared to baseline in dyslipidemic patients. This indicates that saroglitazar reduces predictor lipid biomarkers of cardiovascular diseases [45]. In addition, several clinical studies investigated the effect of saroglitazar in NAFLD/NASH patients.…”

Section: Discussionmentioning

confidence: 96%

Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Krishnappa

Patil

Parmar

et al. 2020

Cardiovasc Diabetol

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Background: 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. Methods: 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. Results: 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.

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Section: Discussionmentioning

confidence: 96%

Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Krishnappa

Patil

Parmar

et al. 2020

Cardiovasc Diabetol

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“…A few months later, it received a second approval as a first line treatment for Non-Alcoholic Fatty Liver Disease (NAFLD). [41,42] Muraglitazar (Scheme 10), another analogue of this family, was developed by researchers at Bristol-Myers Squibb, with dual PPARα/γ agonistic activity and in vivo efficacy in animal models of DT2 and dyslipidemia. Its circulation was approved after completing clinical trials, but it was later discontinued due to cases of heart failure.…”

Section: Dual Pparα/γ Agonistsmentioning

confidence: 99%

“…This resulted in its approval for co‐administration with metformin , in DT2 patients, in 2020. A few months later, it received a second approval as a first line treatment for Non‐Alcoholic Fatty Liver Disease (NAFLD) [41,42] …”

Section: Diabetes Mellitusmentioning

confidence: 99%

Design of Improved Antidiabetic Drugs: A Journey from Single to Multitarget Agents

2022

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Multifactorial diseases exhibit a complex pathophysiology with several factors contributing to their pathogenesis and development. Examples of such disorders are neurodegenerative (e. g. Alzheimer's, Parkinson's) and cardiovascular diseases (e. g. atherosclerosis, metabolic syndrome, diabetes II). Traditional therapeutic approaches with single‐target drugs have been proven, in many cases, unsatisfactory for the treatment of multifactorial diseases such as diabetes II. The well‐established by now strategy of multitarget drugs is constantly gaining interest and momentum, as a more effective approach. The development of pharmacomolecules able to simultaneously modulate multiple relevant‐to‐the‐disease targets has already several successful examples in various fields and has, as such, inspired the design of multitarget antidiabetic agents; this review highlights the design aspect and efficacy of this approach for improved antidiabetics by presenting several examples of successful pharmacophore combinations in (multitarget) agents that modulate two or more molecular targets involved in diabetes II, resulting in a superior antihyperglycemic profile.

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Saroglitazar Reduces Predictor Lipid Biomarkers Of Cardiovascular Diseases

Cited by 2 publications

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Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Design of Improved Antidiabetic Drugs: A Journey from Single to Multitarget Agents

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