Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol

Abstract

Objective. To compare the characteristics of female versus male gout patients and assess urate-lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. Methods. This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level >8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate-lowering efficacy, which was defined as the proportion of subjects with sUA levels <6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function. Results. Female gout subjects (n ‫؍‬ 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels <6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate-lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P < 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea. Conclusion. These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.

Sex differences in response to allopurinol and benzbromarone in gout: a retrospective cohort study

“…Unfortunately, reliable subgroup analyses by sex are very rare in existing allopurinol studies because the proportion of women is often 10% or less. In a previous study looking at the efficacy of febuxostat and allopurinol in women using data from three randomized controlled trials, only 226 women of the >4000 patients were included [ 7 ].…”

Gender characteristics of gout and differences in response to taking xanthioxidase inhibitors

“…Однако общим выво-дом было то, что подагра возникает у женщин в более позднем возрасте, чаще сопровождается сопутствующими заболеваниями, в лечении которых используются диуретики [3][4][5]. Существует мало данных о возможной разнице в ответе на терапию, снижающую уровень мочевой кислоты, у мужчин и женщин [7][8][9]. Особенностью нашей работы было сопоставление клинических характеристик течения подагры у мужчин и женщин и оценка гендерных различий в ответе на уратснижающую терапию (УСТ) аллопуринолом и фебуксостатом.…”

Long-Term Inhibition of Xanthine Oxidase by Febuxostat Does Not Decrease Blood Pressure in Deoxycorticosterone Acetate (DOCA)-Salt Hypertensive Rats

“…Febuxostat, a new XO inhibitor approved for administration in humans, has been recently demonstrated in clinical studies as superior in both safety and efficacy to allopurinol [23], [24], [25], [26], [32]. Moreover, Johnson et al showed that febuxostat decreased BP in hypertensive hyperuricemic rats fed a high fructose diet [28] as well as in the hyperuricemic hypertensive rats treated with the uricase inhibitor oxonic acid [29], [30].…”