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A 25 mg twice daily namodenoson
appears to be effective and safe to manage non-alcoholic fatty liver disease (NAFLD).
Namodenoson (25 mg twice daily) was found to be safe and displayed efficacy signal in patients with NAFLD with or without non-alcoholic steatohepatitis (NASH), according to the findings of phase 2 double-blind study published in Alimentary Pharmacology & Therapeutics. Rifaat Safadi et al. undertook a randomized clinical trial for investigating safety and efficacy of namodenoson, an A3 adenosine receptor agonist to treat NAFLD.
Overall, 60 people suffering from NAFLD (alanine aminotransferase [ALT] ≥60 IU/L) were randomized to oral namodenoson 12.5 mg twice daily [b.d.] (n = 21), 25 mg b.d. (n = 19), or placebo (n = 20) for twelve weeks with the total follow-up of sixteen weeks. The major efficacy outcome was serum ALT following twelve weeks of therapy.
The serum ALT was found to drop in a dose-dependent manner over time with namodenoson. For ALT, difference between alteration from baseline in the namodenoson 25 mg b.d. group vs placebo was noted to trend towards significance at twelve weeks. The levels of serum aspartate aminotransferase (AST) also dropped with namodenoson in a dose-dependent way.
At twelve weeks, the alteration from baseline for 25 mg b.d. vs placebo was significant. At Week 12 and Week 16, the percentage of participants in the 25 mg b.d. namodenoson group and placebo group attaining ALT normalization is shown in Table 1:
The adenosine A3 receptor expression levels were stable over time across the study groups. Both 12.5 mg and 25 mg doses of namodenoson showed good tolerability with no drug-emergent severe adverse events, deaths, drug-drug interactions, or hepatotoxicity. Notably, 3 noxious events were considered possibly associated with study therapy: headache, muscular weakness (25 mg b.d. namodenoson), and myalgia (12.5 mg b.d. namodenoson). Thus, the A3 adenosine receptor seems to be a valid target for the treatment of NAFLD.
Alimentary Pharmacology & Therapeutics
Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis
Rifaat Safadi et al.
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