Abstract
BackgroundSaroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively. It was granted marketing authorization in India in 2013 for diabetic dyslipidemia. This review was conducted to summarize the effects of Saroglitazar in patients with diabetic dyslipidemia in real world clinical studies conducted after marketing authorization in India.MethodsIn this review, we selected real world clinical studies of Saroglitazar published as manuscripts and abstracts presented at scientific conferences. In all these studies, patients with diabetic dyslipidemia were treated with Saroglitazar 4 mg once daily for at least 12 weeks and different lipid and glycemic parameters were measured at the baseline and end of the study.ResultsIn 18 selected studies (5 published manuscripts and 13 abstracts), a total of 5824 patients with diabetic dyslipidemia were prescribed Saroglitazar 4 mg for a duration ranging from 12 to 58 weeks. Across all the studies, mean age of patients ranged from 49.6 to 59.1 years and the proportion of female patients ranged from 22% to 42%. Across all the studies, there was a consistent mean reduction in triglyceride levels (~ 45% to 62%), total cholesterol levels (~ 17% to 26%), non-high-density lipoprotein cholesterol levels (~ 21% to 36%), low-density lipoprotein cholesterol levels (~ 11% to 27%), and glycosylated hemoglobin levels (~ 0.7% to 1.6%) with an increase in mean high-density lipoprotein cholesterol levels (up to 9%) from baseline to end of the study. Saroglitazar also improved alanine aminotransferase levels and fatty liver (evaluated by FibroScan™) in non-alcoholic fatty liver disease patients with diabetic dyslipidemia. Body weight remained unchanged and no significant adverse events (AEs) were reported in the studies.ConclusionSaroglitazar effectively improved lipid and glycemic parameters without significant AEs in patients with diabetic dyslipidemia in real-world clinical studies of up to 58 weeks duration.
Highlights
Saroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively
With the rising prevalence of Type 2 diabetes mellitus (T2DM) and dyslipidemia, Cardiovascular diseases (CVDs) have emerged as major public health threats worldwide [3,4,5]
Dyslipidemia in T2DM, known as diabetic dyslipidemia, is characterised by high levels of triglyceride (TG) and small-dense low-density lipoprotein cholesterol, low levels of highdensity lipoprotein cholesterol (HDL-C), and increased insulin resistance, all of which increase the risk of CVDs [6]
Summary
Saroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively. It was granted marketing authorization in India in 2013 for diabetic dyslipidemia. Dyslipidemia in T2DM, known as diabetic dyslipidemia, is characterised by high levels of triglyceride (TG) and small-dense low-density lipoprotein cholesterol (sd-LDL-C), low levels of highdensity lipoprotein cholesterol (HDL-C), and increased insulin resistance, all of which increase the risk of CVDs [6]. Treatments targeting high TG, high non-HDLC, and low HDL-C could be more effective in reducing the residual risk for future CVDs [7,8,9]
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