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Safety and efficacy of FGF21 analogs in nonalcoholic steatohepatitis: a meta-analysis of randomized clinical trials
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  • Milene Sobral,
  • Hilária Faria,
  • Lucas Bendaham,
  • Barbara Masiero,
  • Celine Gouvêa,
  • Giovana Faria,
  • Maria Santos,
  • Clara Peres,
  • Lídia Ovileira,
  • Eduardo Souto
Milene Sobral
Western Sao Paulo University Faculty of Medicine

Corresponding Author:[email protected]

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Hilária Faria
Federal University of Santa Maria
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Lucas Bendaham
Federal University of Roraima
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Barbara Masiero
Pontifical Catholic University of Rio Grande do Sul
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Celine Gouvêa
National University of La Plata
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Giovana Faria
Centro Universitario Barao de Maua
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Maria Santos
University Salvador
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Clara Peres
University of Pernambuco
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Lídia Ovileira
University São Judas Tadeu
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Eduardo Souto
University Hospital of Santa Maria
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Introduction: The efficacy and safety of fibroblast growth factor 21 (FGF21) analogs in patients with nonalcoholic steatohepatitis (NASH) remains unclear. Therefore, we aimed to compare the use of FGF21 analogs with placebo in patients with NASH. Methods: We searched Medline, Embase, and Cochrane databases from inception to December 2023. The primary outcomes were: triglycerides levels, high-density lipoprotein (HDL) levels, low-density lipoprotein (LDL) levels, NASH resolution, N-terminal type III collagen propeptide (PRO-C3) levels, and adverse events. Subgroup analyses were performed according to drug dosages. We used Review Manager 5.4 to pool the data, assessing heterogeneity with I2. Results: Eight studies reporting data of 967 patients were included in this review. Follow-up ranged from 16 to 121 weeks and dosage ranged from 3 to 70mg a day. When compared to placebo, FGF21 analogs were significantly associated with a reduction in triglycerides (MD -22.07; 95% CI -36.67 to -7.47) and PRO-C3 (MD -6.12; 95% CI -8.05 to -4.20). There were no significant differences in the resolution of NASH (RR 3.57; 95% CI 0.91 to 13.94). Higher rates of adverse events (RR 1.08; 95% CI 1.01 to 1.14) were observed in patients who received the intervention. Conclusion: Despite a higher incidence of adverse events for FGF21 analogs, they showed positive effects on the lipid profile and biomarker for the formation of fibrotic tissue. However, no improvement in NASH resolution was observed. Keywords: FGF21 analog; pegozafermin; efruxifermin; pegbelfermin; fibrosis; NASH.