Adherence to urate-lowering therapy (ULT) in people with gout is often poor. A recent systematic review revealed 10%–46% of people with gout adhere to treatment.1 Among chronic diseases, gout has particularly low adherence rates.2 Adherence in clinical trials of ULT is a particularly important issue, as the primary efficacy endpoint for most studies (including phase III studies that form the basis of regulatory approval) is the ability of the agent to reduce serum urate (SU). Pill count-based adherence ≥80% is frequently regarded as an appropriate cut-off for good adherence; however, this is an indirect measure. Measurement of drug concentration may be an improved measure of the adherence.3 The aim of this study was to establish the relationship between two different measures of adherence and SU endpoints in a clinical trial of allopurinol in gout. Data, including demographics, SU, estimated glomerular filtration rate (eGFR), and plasma oxypurinol and allopurinol concentrations were available from a single study visit, and cumulative pill counts from the entire study period were available for 395 …

中文翻译：

---

血浆氧嘌呤醇作为临床试验依从性的衡量标准

痛风患者对降尿酸治疗 (ULT) 的依从性通常很差。最近的一项系统评价显示，10%–46% 的痛风患者坚持治疗。1 在慢性疾病中，痛风的坚持率特别低。 2 ULT 临床试验的依从性是一个特别重要的问题，作为大多数患者的主要疗效终点研究（包括构成监管批准基础的 III 期研究）是药物降低血清尿酸 (SU) 的能力。基于药丸计数的依从性 ≥ 80% 通常被认为是良好依从性的合适临界值；然而，这是一种间接措施。药物浓度的测量可能是一种改进的依从性测量。3 本研究的目的是在痛风的别嘌呤醇临床试验中建立两种不同的依从性测量与 SU 终点之间的关系。