Barradell L B, Goa K L
Adis International Limited, Auckland, New Zealand.
Pharmacoeconomics. 1995 Nov;8(5):428-59. doi: 10.2165/00019053-199508050-00006.
Alteplase (recombinant tissue plasminogen activator; rt-PA) is a thrombolytic agent that when given in an accelerated regimen with intravenous heparin has survival advantages compared with streptokinase in the treatment of acute myocardial infarction, as shown by the results of the Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial. Although alteplase is more fibrin-specific than streptokinase, alteplase therapy is associated with a small relative increase in the incidence of haemorrhagic stroke, but appears to cause a small relative decrease in the incidence of major bleeding. Because alteplase has a higher acquisition cost than alternative thrombolytic agents, analyses have been undertaken to assess whether administration of alteplase after myocardial infarction is a cost-effective use of healthcare resources. In retrospective analyses undertaken before completion of the GUSTO trial, it was generally assumed, on the basis of better 90-minute patency rates, that alteplase would provide survival advantages compared with streptokinase or conventional nonthrombolytic therapy. Alteplase had acceptable cost-effectiveness ratios compared with conventional therapy and streptokinase therapy from both third-party payer and hospital perspectives. Subgroup analyses demonstrated that alteplase was more cost effective when given early after symptom onset and when given to patients with large infarcts. Prospective evaluations of the cost effectiveness of alteplase in 3-hour and accelerated regimens have similarly demonstrated that alteplase therapy after myocardial infarction improves survival at an 'acceptable' cost. The largest prospective evaluation undertaken to date was performed in conjunction with the GUSTO trial. Primary analysis, on the basis of the clinical findings of the GUSTO trial and prospective collection of cost data from US patients, revealed that the cost-effectiveness ratio for accelerated alteplase therapy compared with streptokinase was $US32,687 (1993 dollars) per year of life saved (YLS). This value is most relevant for US patients and lies within the definition of 'cost effective' if $US50,000/YLS is the benchmark for acceptable use of resources. The cost-effectiveness ratio for alteplase was most sensitive to assumptions regarding long term survival and cost differences after the first year following treatment. In subgroup analyses, alteplase was a cost-effective treatment option for all elderly patients (> 60 years of age) and all patients > 40 years of age with anterior infarction. Alteplase therapy appears to have in-hospital costs/charges similar to those for primary percutaneous transluminal coronary angioplasty (PTCA), mainly because PTCA appears to have a favourable effect on duration of hospitalisation. Given the technical expertise and facilities required for PTCA, it is likely that thrombolytic therapy will remain the management option of choice in most centres. In conclusion, under the conditions of the GUSTO study, accelerated alteplase in combination with intravenous heparin confers survival advantages compared with streptokinase therapy. While decision-makers must choose how best to use their available healthcare resources, pharmacoeconomic evaluations have confirmed that, on the basis of accepted benchmark values, alteplase therapy is a cost-effective therapeutic option for the treatment of acute myocardial infarction, especially in elderly patients with either anterior or inferior infarcts and nearly all patients with anterior myocardial infarction. Thus, on the basis of clinical and economic data, predominantly provided by the GUSTO trial, alteplase is a cost-effective first-line management option for acute myocardial infarction.
阿替普酶(重组组织型纤溶酶原激活剂;rt - PA)是一种溶栓剂,在急性心肌梗死治疗中,与链激酶相比,采用加速给药方案并联合静脉注射肝素时,具有生存优势,这已被全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞冠状动脉(GUSTO)试验的结果所证实。尽管阿替普酶比链激酶对纤维蛋白更具特异性,但阿替普酶治疗与出血性卒中发生率的相对小幅增加相关,不过似乎会使大出血发生率相对小幅降低。由于阿替普酶的购置成本高于其他溶栓剂,因此已开展分析以评估心肌梗死后使用阿替普酶是否是对医疗资源的成本效益高的利用方式。在GUSTO试验完成之前进行的回顾性分析中,基于更好的90分钟血管通畅率,通常认为与链激酶或传统非溶栓治疗相比,阿替普酶能提供生存优势。从第三方付款人和医院的角度来看,与传统治疗和链激酶治疗相比,阿替普酶具有可接受的成本效益比。亚组分析表明,症状发作后早期给药以及给大面积梗死患者使用阿替普酶时,成本效益更高。对阿替普酶在3小时和加速给药方案中的成本效益进行的前瞻性评估同样表明,心肌梗死后使用阿替普酶治疗能以“可接受”的成本提高生存率。迄今为止进行的最大规模前瞻性评估是与GUSTO试验联合开展的。基于GUSTO试验的临床结果以及对美国患者成本数据的前瞻性收集进行的初步分析显示,与链激酶相比,加速阿替普酶治疗的成本效益比为每挽救一年生命(YLS)32,687美元(1993年美元)。这个数值与美国患者最为相关,如果以50,000美元/YLS作为资源合理使用的基准,该数值处于“成本效益高”的定义范围内。阿替普酶的成本效益比对治疗后第一年之后的长期生存和成本差异的假设最为敏感。在亚组分析中,对于所有老年患者(> 60岁)以及所有年龄> 40岁且有前壁梗死的患者,阿替普酶是一种具有成本效益的治疗选择。阿替普酶治疗的住院成本/费用似乎与直接经皮腔内冠状动脉成形术(PTCA)相似,主要是因为PTCA似乎对住院时间有有利影响。鉴于PTCA所需的技术专长和设施,在大多数中心溶栓治疗可能仍是首选的治疗选择。总之,在GUSTO研究的条件下,与链激酶治疗相比,加速阿替普酶联合静脉注射肝素具有生存优势。虽然决策者必须选择如何最佳利用现有的医疗资源,但药物经济学评估已证实,基于公认的基准值,阿替普酶治疗是治疗急性心肌梗死的一种具有成本效益的治疗选择,尤其是对于有前壁或下壁梗死的老年患者以及几乎所有前壁心肌梗死患者。因此,基于主要由GUSTO试验提供的临床和经济数据,阿替普酶是急性心肌梗死具有成本效益的一线治疗选择。