Women with gout: Efficacy and safety of urate-lowering with febuxostat and allopurinol
Women with gout: Efficacy and safety of urate-lowering with febuxostat and allopurinol
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DOI：
10.1002/acr.20680
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发表时间：
2012-02-01
影响因子：
4.7
通讯作者：
Jackson, Robert L.
中科院分区：
文献类型：
--
作者：
Chohan, Saima;Becker, Michael A.;Jackson, Robert L.
目的比较女性与男性痛风患者的特点，评价非布司他或别嘌呤醇治疗女性痛风患者降尿酸的有效性和安全性。这是一项对4101名高尿酸血症（血清尿酸[sUA]水平> 8.0 mg/dl）痛风患者的回顾性分析，他们参加了3项III期比较试验，随机接受安慰剂、非布司他（每天40 mg、80 mg、120 mg或240 mg）或别嘌呤醇（根据肾功能，每天100 mg、200 mg或300 mg）。对男女受试者的基线人口统计和特征进行总结和比较。根据基线肾功能，对所有受试者和女性受试者的尿酸降低效果进行评估，其定义为最终访视时sUA水平< 6.0 mg/dl的受试者比例。女性痛风受试者（n = 226）年龄较大，肥胖、代谢和心血管合并症的发生率明显高于男性受试者。在最后一次访问时，女性受试者sUA水平< 6.0 mg/dl的比例在安慰剂组为0%，在非布司他40 mg、80 mg、120 mg和240 mg组分别为54.3%、85.1%、81.0%和100.0%，在别嘌呤醇组为45.9%。当按肾功能分层时，观察到类似的降尿酸有效率模式。在所有女性受试者中，非布司他80 mg显著优于别嘌呤醇（P < 0.001）。不良事件发生率（ae）较低。最常见的不良反应是上呼吸道感染、肌肉骨骼/结缔组织疾病和腹泻。这些数据表明，非布司他80mg对于合并症发生率高的女性痛风患者可能比常用处方剂量的别嘌呤醇更有效。
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.