Sukkha Sayamon, Chumnumwat Supatat, Thongsoi Pattaranun, Sonsiri Rawiphon, Lohachatinante Apisara, Kittikunkanyakit Nuttanun, Chawanasuntharapot Rattana, Kongwatcharapong Junporn
Clinical Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
Department of Nephrology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Clin Transl Sci. 2025 May;18(5):e70238. doi: 10.1111/cts.70238.
The Thai Food and Drug Administration (TFDA) has approved direct oral anticoagulant (DOAC) dosing based on estimated creatinine clearance, eCrCl (Cockcroft-Gault equation). However, other renal function equations are often used in practice for patients with kidney disease, leading to potential discrepancies in DOAC dosing recommendations. The actual DOAC dosing patterns in resource-limited countries remain underreported. This cross-sectional study included patients with renal impairment who were treated at the outpatient department of Siriraj Hospital, Mahidol University, Thailand. Patients received their first DOAC for atrial fibrillation from January 2019 to December 2022. The primary objective was to evaluate the percentage of DOAC prescriptions compliant with TFDA guidelines using eCrCl. We also examined dosing agreement when substituting estimated glomerular filtration rate, eGFR (CKD-EPI) for eCrCl. Patient factors and the incidence of stroke and bleeding over a one-year follow-up were also assessed. A total of 326 patients and 1587 DOAC prescriptions were analyzed. The mean patient age was 79.1 ± 9.2 years, with a mean eGFR of 45.6 ± 9.9 mL/min/1.73 m. TFDA-compliant dosing was observed in 68.2% of prescriptions. Dose disagreement between eGFR and eCrCl was 45%, with a trend toward overdosing using eGFR. An eGFR of less than 45 mL/min/1.73 m was associated with dose discrepancies. Stroke and bleeding incidences were low, with no differences across DOAC types. While most Thai patients received appropriate DOAC dosing, one-third did not comply with TFDA guidelines. Using eGFR instead of eCrCl may result in dosing differences, particularly in moderate to severe renal impairment.
泰国食品药品管理局(TFDA)已批准根据估算的肌酐清除率(eCrCl,Cockcroft-Gault方程)来确定直接口服抗凝剂(DOAC)的剂量。然而,在实际临床中,对于肾病患者,常使用其他肾功能方程,这可能导致DOAC剂量推荐出现潜在差异。资源有限国家的实际DOAC给药模式仍鲜有报道。这项横断面研究纳入了在泰国玛希隆大学诗里拉吉医院门诊部接受治疗的肾功能不全患者。患者于2019年1月至2022年12月首次接受用于房颤治疗的DOAC。主要目的是评估使用eCrCl时符合TFDA指南的DOAC处方比例。我们还研究了用估算肾小球滤过率(eGFR,CKD-EPI方程)替代eCrCl时的剂量一致性。此外,还评估了患者因素以及一年随访期内的中风和出血发生率。共分析了326例患者和1587张DOAC处方。患者平均年龄为79.1±9.2岁,平均eGFR为45.6±9.9 mL/min/1.73m²。68.2%的处方符合TFDA规定的剂量。eGFR与eCrCl之间的剂量差异率为45%,使用eGFR时有剂量过量的趋势。eGFR低于45 mL/min/1.73m²与剂量差异有关。中风和出血发生率较低,不同DOAC类型之间无差异。虽然大多数泰国患者接受了适当的DOAC剂量,但仍有三分之一的患者未遵循TFDA指南。使用eGFR而非eCrCl可能会导致剂量差异,尤其是在中重度肾功能不全患者中。