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Hepatology: PPAR-α/β agonist Saroglitazar for non-alcoholic fatty liver
Hepatology: PPAR-α/β agonist Saroglitazar for non-alcoholic fatty liver . Non-alcoholic fatty liver disease (NAFLD) is characterized by insulin resistance and disorders of lipid and glucose metabolism.
Non-alcoholic fatty liver disease (NAFLD) is characterized by insulin resistance and disorders of lipid and glucose metabolism. Saroglitazar is a new type of dual peroxisome proliferator-activated receptor-α/γ agonist, which can improve insulin sensitivity and improve blood lipid and blood glucose parameters. In previous animal experiments, Saroglitazar improved the histology of non-alcoholic steatohepatitis (NASH). In this randomized controlled clinical trial, researchers evaluated the effectiveness and safety of Saroglitazar in the treatment of NAFLD/NASH.
106 patients with ALT≥50 U/L and body mass index ≥25 kg/m2NAFLD/NASH were randomly assigned to receive placebo or Saroglitazar 1 mg, 2 mg or 4 mg for 16 weeks at a ratio of 1:1:1:1. The primary efficacy endpoint is the percentage change in ALT levels from baseline at week 16. The liver fat content (LFC) was evaluated by magnetic resonance imaging-proton density fat score.
At 16 weeks, the least squares percentage change of ALT from baseline in the Saroglitazar 1 mg, 2 mg, and 4 mg groups were -25.5% (5.8%), -27.7% (5.9%), and -45.8% (5.7%), respectively. The placebo group was 3.4% (5.6%) (all P values <0.001).
Compared with placebo, 4 mg Saroglitazar improved LFC [4.1%, 5.9% vs -19.7% (5.6)], adiponectin [-0.3 µg/ml(0.3) vs 1.3 µg/ml(0.3)], stable State model assessment-insulin resistance [-1.3(1.8) vs -6.3(1.7)], triglycerides [-5.3 mg/dl(10.7) vs -68.7 mg/dl(10.3)] (all P values <0.05).
Saroglitazar 4 mg can also improve the composition and size of lipoprotein particles and reduce the types of lipotoxic lipids. Saroglitazar is well tolerated. Patients in the Saroglitazar 4 mg group gained an average weight of 1.5 kg, while patients taking placebo gained an average weight of 0.3 kg (P>0.05).
This study shows that Saroglitazar 4mg can significantly improve ALT, LFC, insulin resistance and atherosclerotic dyslipidemia in NAFLD/NASH participants.
(source:internet, reference only)