Febuxostat and Allopurinol Have Similar Hepatic Safety Profiles in Gout Patients

Gout, a painful form of arthritis caused by excess uric acid in the blood, often requires long-term management, making the assessment of medication safety crucial. A recent study published in the Therapeutics and Clinical Risk Management that adult gout patients participating in the RCTs included in the study displayed similar hepatic safety profiles when treated with either febuxostat or allopurinol.

Christiyanti Dewi and team scoured multiple databases, including PubMed, Cochrane Library, and Scopus focusing on randomized controlled trials (RCTs) exclusively. These RCTs directly compared the effects of allopurinol and febuxostat in adult gout patients and included assessments of liver function outcomes. 

Information extracted from these studies included critical details like study design, publication year, patient demographics, sample sizes, duration, Jadad score (a measure of study quality), and liver function outcomes.

Out of 512 publications screened, 11 studies were deemed suitable for inclusion. Notably, 10 of these 11 studies were double-blind RCTs, which are highly regarded for their scientific rigor. In the majority of these trials, no statistically significant differences were observed regarding hepatic safety data between febuxostat and allopurinol. However, it's worth noting that in cases where allopurinol titration was involved, maintaining blinding presented challenges.

One significant observation across all the reviewed RCTs was the presence of consistent adverse events related to liver function. In some instances, these abnormalities led to study withdrawals based on investigators' assessments. Fortunately, these elevations in liver function tests were typically classified as mild to moderate in severity.

This comprehensive analysis has yielded valuable insights. The finding of liver function abnormalities across all RCTs highlights the importance of careful monitoring and awareness by healthcare practitioners when prescribing these medications. Moreover, the study underscores the significance of ongoing pharmacovigilance and post-marketing pharmacoepidemiology data to develop a holistic safety profile. 

Source:

Dewi, C., Puspita, F., Puspitasari, I. M., & Zakiyah, N. (2023). Hepatic Safety of Febuxostat and Allopurinol for Gout Patients: A Systematic Review of Randomized Controlled Trial. In Therapeutics and Clinical Risk Management: Vol. Volume 19 (pp. 731–743). Informa UK Limited. https://doi.org/10.2147/tcrm.s424598