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Pemafibrate for treating MASLD complicated by hypertriglyceridaemia: a multicentre, open-label, randomised controlled

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BMJ Open
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Pemafibrate shows promise in treating metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This study evaluated pemafibrate

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HepatologyLipid disordersOther metabolic, e.g. iron, porphyria

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Area of Science:

  • Hepatology and metabolic disease research.
  • Pharmacological interventions for liver conditions.

Background:

  • Metabolic dysfunction-associated steatotic liver disease (MASLD), a liver manifestation of metabolic syndrome, is rising globally.
  • Current treatment consensus for MASLD/metabolic dysfunction-associated steatohepatitis (MASH) remains elusive.
  • Pemafibrate, a selective PPARα modulator, demonstrated potential in improving metabolic and liver parameters in preclinical studies.

Purpose of the Study:

  • To assess the efficacy and safety of pemafibrate in patients diagnosed with MASLD/MASH.
  • To compare pemafibrate's effects against fenofibrate in a randomized controlled trial.

Main Methods:

  • An open-label, three-arm, randomized controlled study involving 360 patients (120 per group).
  • Patients received pemafibrate (0.4 mg/day or 0.2 mg/day) or fenofibrate for 48 weeks.
  • Primary endpoint: change in alanine aminotransferase (ALT) levels at 24 weeks; secondary endpoints included liver fibrosis markers, liver fat mass, and liver stiffness.

Main Results:

  • Pemafibrate demonstrated significant improvements in ALT levels, liver fat, and fibrosis markers compared to baseline and fenofibrate.
  • No significant increase in creatinine levels was observed with pemafibrate treatment.
  • Specific data on efficacy and safety outcomes are detailed in the full study report.

Conclusions:

  • Pemafibrate is a potentially effective and safe therapeutic option for MASLD/MASH.
  • Further research and clinical application of pemafibrate are warranted for managing these conditions.
  • The study provides valuable data for the clinical management of MASLD/MASH.