Aretha Diamanto, Kiekkas Panagiotis, Sioulas Nektarios, Fligou Fotini
Department of Anesthesiology and Intensive Care Medicine, School of Medicine, University Hospital of Patras, Patras, Greece.
Western Greece University of Applied Sciences, Patras, Greece.
SAGE Open Med. 2020 Sep 30;8:2050312120962338. doi: 10.1177/2050312120962338. eCollection 2020.
Once a patent expires, generic analogue drugs are alternatives to brand name drugs. Because bioequivalence/biodistribution problems have been reported for many generic analogue drugs, we prospectively evaluated 31 patients to reveal the differences in the doses used and the efficacy and adverse events of two different intravenous esmolol formulations.
This was a prospective observational pilot study. Our aim was to reveal the possible differences in the required doses between two different formulations (brand name drug vs generic analogue drug) of intravenous esmolol in beats per minute, systolic blood pressure, diastolic blood pressure and mean arterial pressure in intra- and postoperative patients with supraventricular tachycardia and hypertension. The patients were categorised into two groups according to the medication they received (brand name drug or generic analogue drug).
Esmolol was given to 31 patients (16 generic analogue drug and 15 brand name drug). Although there was a statistically significant difference in bolus (mg/kg) and continued (mg/kg/h) drug dose used (brand name drug/generic analogue drug, mean (standard deviation), 0.3 (0.1) vs 0.38 (0.1), p = 0.03 for bolus dose, and 0.22 (0.09) vs 0.29 (0.08) for continued dose at 10 min (p = 0.03), 0.19 (0.06) vs 0.24 (0.05) at 20 min (p = 0.01) and 0.14 (0.05) vs 0.18 (0.05) at 30 min (p = 0.02)), there were no time-related statistical significant differences in the reduction rates of the two drugs (p = 0.47). There were no time-related statistically significant differences between the two groups in systolic blood pressure, diastolic blood pressure, mean arterial pressure and beats per minute, nor in their adverse events.
In this pilot study, smaller doses were given for controlling the patient's haemodynamics when a brand name drug was used. Because there were no significant time-related differences in the reduction rates of the two drugs nor in any haemodynamic differences between the two groups, optimal titration of the drug used could effectively control the patient's haemodynamics. The adverse events were also similar in both groups.
一旦专利到期，仿制药类似物可作为品牌药的替代品。由于许多仿制药类似物已被报道存在生物等效性/生物分布问题，我们前瞻性地评估了31例患者，以揭示两种不同静脉注射艾司洛尔制剂在剂量使用、疗效及不良事件方面的差异。
这是一项前瞻性观察性试点研究。我们的目的是揭示在患有室上性心动过速和高血压的手术中和术后患者中，两种不同的静脉注射艾司洛尔制剂（品牌药与仿制药类似物）在每分钟心跳次数、收缩压、舒张压和平均动脉压方面所需剂量的可能差异。根据患者所接受的药物治疗（品牌药或仿制药类似物）将患者分为两组。
31例患者接受了艾司洛尔治疗（16例使用仿制药类似物，15例使用品牌药）。尽管在推注（mg/kg）和持续（mg/kg/h）药物剂量使用上存在统计学显著差异（品牌药/仿制药类似物，平均值（标准差），推注剂量为0.3（0.1）对0.38（0.1），p = 0.03；10分钟时持续剂量为0.22（0.09）对0.29（0.08），p = 0.03；20分钟时为0.19（0.06）对0.24（0.05），p = 0.01；30分钟时为0.14（0.05）对0.18（0.05），p = 0.02），但两种药物的降低率无时间相关的统计学显著差异（p = 0.47）。两组在收缩压、舒张压、平均动脉压和每分钟心跳次数方面以及不良事件方面均无时间相关的统计学显著差异。
在这项试点研究中，使用品牌药时给予较小剂量即可控制患者的血流动力学。由于两种药物的降低率以及两组之间在任何血流动力学方面均无显著的时间相关差异，因此对所用药物进行最佳滴定可有效控制患者的血流动力学。两组的不良事件也相似。
