Keele, UK—Last year, the FDA concluded that an increased risk of death exists with use of febuxostat compared with allopurinol for treatment of gout, and updated febuxostat prescribing information to require a Boxed Warning.

In addition to adding its most prominent warning and a new patient medication guide, the FDA also limited the approved use of febuxostat, marketed as Uloric, to certain patients who are not treated effectively or experience severe side effects with allopurinol.

Those actions intensified questions about wider long-term effects of urate-lowering therapy, predominantly allopurinol, in gout treatment.

An article in Arthritis Care & Research reports the results of a systematic review and meta-analysis designed to ascertain the association between allopurinol use in gout patients and mortality.

A study team led by United Kingdom researchers from Keele University searched MEDLINE, EMBASE, CINAHL and the Cochrane Library from inception to August 2018. Eligible for inclusion were articles that used a cohort design and examined cardiovascular or all-cause mortality in patients diagnosed with gout and prescribed allopurinol.

Researchers determined that four articles reported a hazard ratio (HR) risk estimate for all-cause mortality in patients with gout using allopurinol, with two of those also including cardiovascular mortality. They note that two articles found allopurinol to be protective in patients with gout, one found no statistically significant association, and one found no statistically significant effect of escalation of allopurinol dosage on all-cause or cardiovascular-related mortality.

Data pooling was possible for all-cause mortality, according to the article, and found no association between allopurinol use in patients with gout and all-cause mortality compared with patients with gout who were not using allopurinol (adjusted HR 0.80; 95% CI, 0.60, 1.05).

“There was no significant association between all-cause mortality and allopurinol use in people with gout,” the authors conclude. “However, the number of included studies was small, suggesting that further studies are needed.”

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