Study Objectives Long-term dopamine agonist (DA) use in restless legs syndrome (RLS) is associated with augmentation, a dose-related symptom worsening leading to further dose escalation to manage RLS. This study investigated rates and factors of high-dose DA prescribing in US RLS patients. Methods This retrospective analysis examined data from a US longitudinal prescriptions database (October 2017–September 2018). Patients diagnosed with RLS (ICD-10 G255.81) without Parkinson’s disease who were prescribed ropinirole, pramipexole, and/or rotigotine were included. Daily DA dosage was categorized: LOW/MID (US Food and Drug Administration [FDA]-approved/guideline or slightly above FDA-approved [pramipexole]); HIGH (101%–149%); VERY HIGH (>150%). Patient counts were converted to US national estimates. Logistic regression of patient counts evaluated factors associated with HIGH/VERY HIGH DA dosing. Results Of 670,404 RLS patients (131,289,331 therapy days), 58.8% were prescribed DA therapy. Overall, 19.1% of RLS patients were prescribed DAs above maximum FDA-approved/guideline daily doses—over half of these were >150% maximum recommended doses; 67.6% of HIGH/VERY HIGH-dose prescriptions were pramipexole (OR [95% CI] pramipexole vs ropinirole, 5.8 [5.7 to 6.0]). The highest 1% of DA prescriptions were ≥10× the FDA-recommended maximum daily dose. Rates of HIGH/VERY HIGH DA dosing increased with patient age. Twice as many neurologists (31.1%) prescribed HIGH/VERY HIGH doses vs other specialties (OR [95% CI], 2.1 [1.2 to 2.0]). Conclusions Approximately 20% of DA-treated RLS patients were prescribed doses above the approved and guideline daily maximum. Pramipexole, Neurology as specialty, and patient age were independently associated with HIGH/VERY HIGH DA dosing. Increased education is warranted regarding risks of high-dose DA exposure in RLS.

中文翻译：

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全国高剂量多巴胺激动剂处方不宁腿综合征的高比率

研究目标 长期多巴胺激动剂 (DA) 用于不宁腿综合征 (RLS) 与增强有关，这是一种与剂量相关的症状恶化，导致进一步增加剂量以控制 RLS。本研究调查了美国 RLS 患者中大剂量 DA 处方的比率和因素。方法 这项回顾性分析检查了来自美国纵向处方数据库（2017 年 10 月至 2018 年 9 月）的数据。包括被诊断为 RLS (ICD-10 G255.81) 且没有帕金森病的患者，这些患者接受了罗匹尼罗、普拉克索和/或罗替戈汀的处方。每日 DA 剂量分为：低/中（美国食品和药物管理局 [FDA] 批准/指南或略高于 FDA 批准 [普拉克索]）；高 (101%–149%); 非常高（＞150%）。患者人数被转换为美国国家估计数。患者计数的逻辑回归评估了与高/非常高 DA 剂量相关的因素。结果 670,404 名 RLS 患者（131,289,331 治疗天）中，58.8% 接受了 DA 治疗。总体而言，19.1% 的 RLS 患者开出的 DAs 高于 FDA 批准/指南的最大每日剂量——其中一半以上是最大推荐剂量的 150%；67.6% 的高/非常高剂量处方是普拉克索（OR [95% CI] 普拉克索与罗匹尼罗，5.8 [5.7 至 6.0]）。最高 1% 的 DA 处方≥10 倍 FDA 推荐的最大日剂量。高/非常高 DA 给药率随着患者年龄的增长而增加。与其他专科医师相比，开出高/非常高剂量的神经科医生 (31.1%) 是其两倍 (OR [95% CI], 2.1 [1.2 to 2.0])。结论 大约 20% 接受 DA 治疗的 RLS 患者的处方剂量高于批准的和指导的每日最大剂量。普拉克索、神经病学专业和患者年龄与高/非常高 DA 剂量独立相关。需要加强关于 RLS 中高剂量 DA 暴露风险的教育。