Medical Science Department, Teijin Pharma Limited, Tokyo, Japan.
Pharmaceutical Development Administration Department, Teijin Pharma Limited, Tokyo, Japan.
Pharmacoepidemiol Drug Saf. 2021 Feb;30(2):157-168. doi: 10.1002/pds.5127. Epub 2020 Sep 16.
This study assessed factors associated with achieving target serum uric acid (sUA) level and occurrence of gouty arthritis in Japanese clinical practice.
Japanese health insurance claims and medical check-up data from October 2015 to March 2017 were analyzed to assess factors associated with target sUA achievement in gout and asymptomatic hyperuricemia and gouty arthritis in gout. Target sUA was further assessed by subgroup analysis of urate-lowering therapy (ULT) prescriptions and outcomes, stratified by renal function.
Patients achieving target sUA tended toward older, female, higher ULT dose, higher adherence, more comorbidities, and/or antidiabetic drugs prescribed. Renal dysfunction and/or diuretic prescriptions were associated with reduced achievement of target sUA. Severe renal dysfunction was particularly influential (odds ratio [OR] = 0.22 [95% confidence interval (CI): 0.10-0.48] for <15, 0.15 [0.10-0.23] for ≥15 to <30, compared with eGFR ≥90 mL/min/1.73 m ). Across all renal function categories, mean prescribed ULT dose was low (febuxostat 17.0-21.0 mg/day, allopurinol 123.1-139.6 mg/day), and target sUA achievement was reduced among renal dysfunction patients. Gouty arthritis was more likely in patients with a prior history of such occurrences, and less likely for higher ULT adherence, sUA monitored regularly at medical facilities, and/or more comorbidities.
In a real-world setting, severe renal dysfunction is the most important risk factor for failure to achieve the target sUA, suggesting suboptimal disease management in patients with gout or hyperuricemia complicated by this condition. Findings associated with gouty arthritis suggest that these occurrences could be successfully managed by regular monitoring of sUA and closer adherence to ULT.
本研究评估了在日本临床实践中与实现目标血清尿酸(sUA)水平和痛风性关节炎发生相关的因素。
分析了 2015 年 10 月至 2017 年 3 月的日本健康保险索赔和体检数据,以评估痛风和无症状高尿酸血症及痛风患者中与实现目标 sUA 相关的因素。通过降低尿酸治疗(ULT)处方和结局的亚组分析,进一步评估目标 sUA,按肾功能分层。
达到目标 sUA 的患者倾向于年龄较大、女性、ULT 剂量较高、依从性较高、合并症更多和/或开具了降糖药。肾功能障碍和/或利尿剂处方与目标 sUA 达标率降低相关。严重肾功能障碍的影响尤其显著(与 eGFR≥90 mL/min/1.73 m2相比,<15 的比值比[OR]为 0.22 [95%置信区间[CI]:0.10-0.48],≥15 至<30 的 OR 为 0.15 [0.10-0.23])。在所有肾功能类别中,所开 ULT 剂量均较低(非布司他 17.0-21.0 mg/天,别嘌醇 123.1-139.6 mg/天),肾功能障碍患者的目标 sUA 达标率降低。有既往痛风性关节炎发作史的患者更有可能发生痛风性关节炎,而 ULT 依从性较高、在医疗机构定期监测 sUA 和/或合并症更多的患者发生痛风性关节炎的可能性较低。
在真实环境中,严重肾功能障碍是未能达到目标 sUA 的最重要危险因素,表明伴有这种情况的痛风或高尿酸血症患者的疾病管理欠佳。与痛风性关节炎相关的发现表明,通过定期监测 sUA 和更密切地遵循 ULT,可以成功管理这些发作。