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磺达肝癸钠与依诺肝素预防骨科手术患者血栓栓塞事件的药物经济学分析

Pharmacoeconomic analysis of fondaparinux versus enoxaparin for the prevention of thromboembolic events in orthopedic surgery patients.

作者信息

Dranitsaris George, Kahn Susan R, Stumpo Carmine, Paton Thomas W, Martineau Josee, Smith Reginald, Ginsberg Jeffrey S

机构信息

Augmentium Pharma Consulting, Toronto, Ontario, Canada.

出版信息

Am J Cardiovasc Drugs. 2004;4(5):325-33. doi: 10.2165/00129784-200404050-00005.

Abstract

INTRODUCTION

Fondaparinux is a novel synthetic antithrombotic that has been evaluated for the prevention of venous thromboembolism (VTE). In four large trials in patients who underwent major hip or knee surgery, fondaparinux was found to have a good safety profile and be more effective than enoxaparin. To generate Canadian pharmacoeconomic data for fondaparinux, an internationally developed cohort deterministic model was used to estimate the costs and consequences of prophylaxis with fondaparinux compared with enoxaparin in the Canadian orthopedic surgical setting.

DESIGN AND SETTING

A health economic advisory group was assembled to guide the pharmacoeconomic evaluation. Efficacy and safety data for fondaparinux relative to enoxaparin were abstracted from a meta-analysis of four randomized trials. Canadian cost data to populate the model were obtained from a resource-use survey of four large Canadian hospitals, from the Canadian Institute for Health Information (CIHI), and from the Canadian economic literature. Case-mix information obtained from CIHI was incorporated into the cohort deterministic model, which predicted the number of VTEs and bleeds following prophylaxis with fondaparinux or enoxaparin within 90 days of surgery, and the associated overall cost difference. The stability of the base-case findings was evaluated with sensitivity analyses.

STUDY PERSPECTIVE

Canadian healthcare system perspective.

MAIN OUTCOME MEASURES AND RESULTS

Assuming a case mix of 50,693 major hip or knee surgeries performed in Canada in 1999/2000 (as reported by CIHI), the model predicted that prophylaxis with fondaparinux would avoid an additional 16 symptomatic VTEs per 1000 patients over the first 90 days, with an average cost savings of Can 55 dollars per patient. These findings were stable when key economic and clinical parameters were varied, including bleeding events.

CONCLUSIONS

Our results suggest that in Canada, prophylactic fondaparinux compared with enoxaparin avoids VTEs and is associated with lower costs in patients who undergo major hip or knee surgery.

摘要

引言

磺达肝癸钠是一种新型合成抗栓药物,已被评估用于预防静脉血栓栓塞症(VTE)。在四项针对接受大髋关节或膝关节手术患者的大型试验中,发现磺达肝癸钠具有良好的安全性,且比依诺肝素更有效。为了生成加拿大关于磺达肝癸钠的药物经济学数据,使用了一个国际开发的队列确定性模型来估计在加拿大骨科手术环境中,与依诺肝素相比,使用磺达肝癸钠进行预防的成本和后果。

设计与背景

组建了一个健康经济咨询小组来指导药物经济学评估。磺达肝癸钠相对于依诺肝素的疗效和安全性数据取自四项随机试验的荟萃分析。用于填充模型的加拿大成本数据来自对四家大型加拿大医院的资源使用调查、加拿大卫生信息研究所(CIHI)以及加拿大经济文献。从CIHI获得的病例组合信息被纳入队列确定性模型,该模型预测了在手术90天内使用磺达肝癸钠或依诺肝素进行预防后VTE和出血的数量,以及相关的总体成本差异。通过敏感性分析评估了基础病例结果的稳定性。

研究视角

加拿大医疗保健系统视角。

主要结局指标与结果

假设1999/2000年在加拿大进行了50,693例大髋关节或膝关节手术(如CIHI所报告),该模型预测,在最初的90天内,每1000例患者使用磺达肝癸钠进行预防可额外避免16例有症状的VTE,平均每位患者节省成本55加元。当关键经济和临床参数(包括出血事件)变化时,这些结果是稳定的。

结论

我们的结果表明,在加拿大,与依诺肝素相比,预防性使用磺达肝癸钠可避免VTE,且在接受大髋关节或膝关节手术的患者中成本更低。

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