Saroglitazar for Nonalcoholic Fatty Liver Disease: A Single Centre Experience in 91 Patients

Padole, Prateek; Arora, Anil; Sharma, Praveen; Chand, Prakash; Verma, Nishant; Kumar, Ashish

doi:10.1016/j.jceh.2021.06.015

Cited by 15 publications

(10 citation statements)

References 31 publications

(25 reference statements)

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“…In humans, a phase 2 randomized, double-blind trial evaluating the effect of saroglitazar on NAFLD patients showed a reduction in liver enzymes at 16 weeks, but also a significant decrease in liver lipid content and an initial reduction in liver stiffness [ 190 ]. These data were confirmed in other nonrandomized studies performed in India, in which a reduction in plasma lipid parameters and liver stiffness was observed [ 191 , 192 , 193 ]. It must be noted, however, that in one of these studies [ 192 ], the reduction in liver stiffness parameters was present only in the treated patients that showed a reduction in body weight >5%.…”

Section: Possible Therapeutic Approachessupporting

confidence: 84%

Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD

Vitulo

Gnodi

Rosini

et al. 2023

IJMS

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Nonalcoholic fatty liver disease (NAFLD, including nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH)) is a high-prevalence disorder, affecting about 1 billion people, which can evolve to more severe conditions like cirrhosis or hepatocellular carcinoma. NAFLD is often concomitant with conditions of the metabolic syndrome, such as central obesity and insulin-resistance, but a specific drug able to revert NAFL and prevent its evolution towards NASH is still lacking. With the liver being a key organ in metabolic processes, the potential therapeutic strategies are many, and range from directly targeting the lipid metabolism to the prevention of tissue inflammation. However, side effects have been reported for the drugs tested up to now. In this review, different approaches to the treatment of NAFLD are presented, including newer therapies and ongoing clinical trials. Particular focus is placed on the reverse cholesterol transport system and on the agonists for nuclear factors like PPAR and FXR, but also drugs initially developed for other conditions such as incretins and thyromimetics along with validated natural compounds that have anti-inflammatory potential. This work provides an overview of the different therapeutic strategies currently being tested for NAFLD, other than, or along with, the recommendation of weight loss.

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Section: Possible Therapeutic Approachessupporting

confidence: 84%

Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD

Vitulo

Gnodi

Rosini

et al. 2023

IJMS

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“…There has been limited data regarding the efficacy of saroglitazar in the Indian population. Padole et al 10 have shown that saroglitazar is effective in reducing transaminase value, but LSM and CAP reduction was seen only in patients who achieved at least 5% weight reduction. This study refutes the same showing improvement in LSM irrespective of weight change.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of saroglitazar in real‐world patients of non‐alcoholic fatty liver disease with or without diabetes including compensated cirrhosis: A tertiary care center experience

2023

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Background and Aim: Saroglitazar, a dual PPAR α/γ agonist, is useful in management of NAFLD and diabetic dyslipidemia. Here, we report the safety and efficacy of saroglitazar in NAFLD patients with or without diabetes including compensated cirrhosis. Methods: Patients, started on saroglitazar 4 mg were prospectively evaluated for 52 weeks in a tertiary care center in Eastern India. Effectiveness was measured in terms of anthropometric measurements, fasting blood glucose, LFT, lipid profile, HbA1c, and elastography parameters (LSM and CAP) measured at baseline, 24, and 52 weeks. Adverse drug reactions were monitored. Results: A total of 112 patients were enrolled in the study, of whom 63 patients were taken up for per-protocol analysis. Mean age was 49.11 AE 11.09 years and 46(73%) were male. Thirty-four (54%) were nondiabetic. Eleven patients had compensated cirrhosis. There was significant improvement of LSM from baseline (11.03 AE 7.19 kPa) to 24-week (9.29 AE 6.39 kPa) and 52-week (8.59 AE 6.35 kPa) values respectively (P < 0.001). Significant reduction was also seen in CAP values, ALT, AST, HbA1c, LDL, total cholesterol, and triglyceride values. There was no significant weight change along the study interval. Pruritus occurred in one patient who required treatment discontinuation and another patient had mild symptomatic loose motion. Conclusions: Saroglitazar is effective and safe in improving biochemical parameters and LSM and CAP values irrespective of weight reduction. It may be used in compensated cirrhotics with close monitoring for side effects.

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“…A more extensive study in 85 patients revealed reduced ALT and triglycerides[ 28 ]. Furthermore, a study of Saroglitazar in 91 patients showed that 57 patients (63%) could reduce ≥ 5% of their weight[ 31 ]. There has been discussion regarding pan-PPAR agonists vs dual agents; Boeckmans et al [ 33 ] compared Elafibranor vs Lanifibranor (pan-PPAR agonist), which identified Elafibranor as having higher anti-NASH properties[ 33 ].…”

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

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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.

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Saroglitazar for Nonalcoholic Fatty Liver Disease: A Single Centre Experience in 91 Patients

Cited by 15 publications

References 31 publications

Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD

Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD

Efficacy and safety of saroglitazar in real‐world patients of non‐alcoholic fatty liver disease with or without diabetes including compensated cirrhosis: A tertiary care center experience

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

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