Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty Liver Patients With Diabetic Dyslipidemia—A Prospective, Interventional, Pilot Study

Rajesh, Nanditha; Drishya, L.; Ambati, Murali Mohan Raju; Narayanan, Athi L.; Alex, Maria; R, Kiran Kumar; Abraham, Justin Jacob; Vijayakumar, T.

doi:10.1016/j.jceh.2021.03.012

Cited by 19 publications

(14 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The main dual-PPAR agonists reviewed here are Ragaglitazar (α/γ)[ 23 ], GFT505 (α/δ)[ 26 , 27 ], Saroglitazar (α/γ)[ 28 - 32 ] and Elafibranor (α/δ)[ 33 , 34 ]. Multiple animal studies involving dual-PPAR agonists have demonstrated promising results, including reduced triglycerides and liver injury markers[ 23 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review

Tidwell,

Balassiano,

Shaikh

et al. 2023

World J Hepatol

View full text Add to dashboard Cite

Primary sclerosing cholangitis (PSC) is a chronic and progressive immune-mediated cholangiopathy causing biliary tree inflammation and scarring, leading to liver cirrhosis and end-stage liver disease. Diagnosis of PSC is challenging due to its nonspecific symptoms and overlap with other liver diseases. Despite the rising incidence of PSC, there is no proven medical therapy that can alter the natural history of the disease. While liver transplantation (LT) is the most effective approach for managing advanced liver disease caused by PSC, post-transplantation recurrence of PSC remains a challenge. Therefore, ongoing research aims to develop better therapies for PSC, and continued efforts are necessary to improve outcomes for patients with PSC. This article provides an overview of PSC’s pathogenesis, clinical presentation, and management options, including LT trends and future aspects. It also highlights the need for improved therapeutic options and ethical considerations in providing equitable access to LT for patients with PSC. Additionally, the impact of liver transplant on the quality of life and psychological outcomes of patients with PSC is discussed. Ongoing research into PSC’s pathogenesis and post-transplant recurrence is crucial for improved understanding of the disease and more effective treatment options.

show abstract

Section: Discussionmentioning

confidence: 99%

Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review

Tidwell,

Balassiano,

Shaikh

et al. 2023

World J Hepatol

View full text Add to dashboard Cite

show abstract

“…Thus, the evidence favors saroglitazar as a beneficial treatment approach for NASH. 26 The use of acetyl CoA carboxylase inhibitors as an augmented form of treatment alongside PPAR agonists has also been studied and further research could help produce better outcomes in patients suffering from NASH. 27 The current study has determined the therapeutic benefits of saroglitazar for the treatment of NASH using an animal model.…”

Section: Discussionmentioning

confidence: 99%

A Study to Evaluate the Efficacy of Saroglitazar in Non-Alcoholic Steatohepatitis Induced by High Fructose Diet Rat Model

T.,

S.,

Thomas

et al. 2023

Journal of Pharmacology and Pharmacotherapeutics

View full text Add to dashboard Cite

Background Non-alcoholic steatohepatitis (NASH) is a clinical condition with a global prevalence of 25.24%. Peroxisome proliferator-activated receptors (PPAR) have been significantly associated with the pathogenesis of NASH. Aim To evaluate the efficacy of saroglitazar in an animal model of NASH by evaluating the magnitude of changes in liver function tests (LFT) and histopathology. Materials and Methods The baseline parameters of 14 male Sprague–Dawley rats were recorded and then grouped into four groups: treatment groups (high high-dose saroglitazar [HDSG] and low low-dose saroglitazar [LDSG] doses of saroglitazar), normal control, and disease control. Initially, except for the normal control, the other three groups were fed a fructose diet for 5 weeks and then all four groups were fed a standard chow diet for the next 2 weeks during which the two treatment groups were orally gavaged with saroglitazar. Changes in LFT, body weight (BW), lipid profile, oxidative stress, and histopathology were evaluated at different time points. Results A statistically significant reduction was found in the mean serum glutamic-oxaloacetic transaminase (SGOT) ( p = 0.0267) and serum glutamate-pyruvate transaminase (SGPT) ( p = 0.0059) between the groups at the end of treatment. As with BW changes ( p < 0.001), a significant difference was observed between the time points in HDSG and LDSG with respect to all parameters of the lipid profile assessed ( p < 0.05). Amelioration of hepatocellular ballooning and lobular inflammation in histopathology was evident in both treatment groups. Immunohistochemistry revealed loss of cytokeratin CK8/18 in disease control while it was preserved in LDSG and HDSG. Conclusion The study has explicitly illustrated the improvement in the biochemical and pathological changes in the rat model of NASH induced by a high fructose diet.

show abstract

“…Two other compounds (Saroglitazar and Lanifibranor) are still being developed for the treatment of NAFLD/NASH and no safety concerns have been reported so far. Saroglitzar has been approved in India since 2013 for treatment of diabetic dyslipidemia and in post-marketing real-world evidence studies in this population saroglitazar has shown to improve liver parameters as well [ 29 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

Improvement of non-invasive tests of liver steatosis and fibrosis as indicators for non-alcoholic fatty liver disease in type 2 diabetes mellitus patients with elevated cardiovascular risk profile using the PPAR-α/γ agonist aleglitazar

et al. 2022

View full text Add to dashboard Cite

Background Peroxisome proliferator-activated receptor (PPAR) agonists may have favorable outcomes on non-alcoholic fatty liver disease. This study serves as proof of concept to evaluate whether dual PPAR-α/γ agonists improve non-invasive tests of liver steatosis and fibrosis. Methods This is a post-hoc analysis of a randomized, double-blind, placebo-controlled, multi-center trial comprising 7226 patients with type 2 diabetes mellitus and recent coronary artery disease randomized to receive aleglitazar, a PPAR-α/γ agonists, or placebo for two years. Main outcomes were change in non-invasive tests for liver steatosis and fibrosis: Liver Fat Score (LFS), Liver Accumulation Product (LAP), Fibrosis-4 (FIB-4), and NAFLD Fibrosis Score (NFS). Results LFS, LAP and FIB-4 decreased upon treatment, whereas scores in the placebo group remained the same or increased (P<0.001). NFS responded differently but remained consistently lower than placebo. In the treatment group more participants shifted to a lower FIB-4 and NFS category, or improved in respect to the LAP cut-off values compared to the placebo group (P<0.001 for FIB-4 and LAP, P<0.004 for NFS). LFS had a low discriminative power in this study. Conclusion This post-hoc analysis showed improvement of non-invasive tests of liver steatosis and fibrosis after starting dual PPAR-α/γ agonist treatment, adding to the evidence that this pathway has potential in non-alcoholic fatty liver disease treatment.

show abstract

Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty Liver Patients With Diabetic Dyslipidemia—A Prospective, Interventional, Pilot Study

Cited by 19 publications

References 20 publications

Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review

Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review

A Study to Evaluate the Efficacy of Saroglitazar in Non-Alcoholic Steatohepatitis Induced by High Fructose Diet Rat Model

Improvement of non-invasive tests of liver steatosis and fibrosis as indicators for non-alcoholic fatty liver disease in type 2 diabetes mellitus patients with elevated cardiovascular risk profile using the PPAR-α/γ agonist aleglitazar

Contact Info

Product

Resources

About