Rodríguez David, Nieto Elena, Quiroga Teresa, Rojas Eric, Vera Francisco
Departamento de Laboratorios Clínicos, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Rev Med Chil. 2020 Sep;148(9):1254-1260. doi: 10.4067/S0034-98872020000901254.
Vitamin K antagonist medications (VKA) are essential for the prevention of thromboembolic events, but their effectiveness is influenced by multiple factors, such as the type of medication chosen.
To evaluate the efficacy in anticoagulant control of the bioequivalent and non-bioequivalent drugs of acenocoumarol compared to the reference drug. To evaluate the efficacy of warfarin bioequivalents available in Chile. To contrast the overall anticoagulant control efficacy between acenocoumarol and warfarin.
The results of 69333 outpatient oral anticoagulation controls were analyzed. Patient were separated in groups according to the drug that they used. Subsequently, the proportions of controls outside the range for each of acenocoumarol and warfarin bioequivalent drugs were compared. Acenocoumarol non-bioequivalent drugs were also compared with the reference drug. Acenocoumarol was compared with warfarin.
Acenocoumarol bioequivalent drugs and the reference drug had a similar proportion of controls outside the range (Odds ratios (OR) 0.812; 0.969; 0.974 and 0.963). Non-bioequivalent drugs had a higher proportion than the reference drug (OR 1.561 and 2.037). Both warfarin brands have a similar proportion of controls outside of the range (OR 1.050). Acenocoumarol compared to warfarin had a significant higher proportion of controls outside the range (OR 1.191).
The pharmacological presentation of vitamin K antagonists could influence anticoagulant control. Therefore, it is not prudent to switch these presentations frequently.
维生素K拮抗剂药物（VKA）对于预防血栓栓塞事件至关重要，但其有效性受多种因素影响，如所选药物类型。
评估醋硝香豆素生物等效和非生物等效药物与参比药物相比在抗凝控制方面的疗效。评估智利可用的华法林生物等效药物的疗效。对比醋硝香豆素和华法林之间的总体抗凝控制疗效。
分析69333例门诊口服抗凝控制的结果。根据患者使用的药物将其分组。随后，比较醋硝香豆素和华法林生物等效药物各自超出范围的控制比例。醋硝香豆素非生物等效药物也与参比药物进行比较。醋硝香豆素与华法林进行比较。
醋硝香豆素生物等效药物和参比药物超出范围的控制比例相似（优势比（OR）分别为0.812、0.969、0.974和0.963）。非生物等效药物超出范围的比例高于参比药物（OR分别为1.561和2.037）。两种华法林品牌超出范围的控制比例相似（OR为1.050）。与华法林相比，醋硝香豆素超出范围的控制比例显著更高（OR为1.191）。
维生素K拮抗剂的药物剂型可能影响抗凝控制。因此，频繁更换这些剂型是不明智的。
