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在加拿大,度他雄胺与坦索罗辛固定剂量复方制剂与度他雄胺和坦索罗辛联合单药治疗良性前列腺增生患者的成本分析。

Cost analysis of fixed-dose combination of dutasteride and tamsulosin compared with concomitant dutasteride and tamsulosin monotherapy in patients with benign prostatic hyperplasia in Canada.

作者信息

Sayani Amyn, Ismaila Afisi, Walker Anna, Posnett John, Laroche Bruno, Nickel J Curtis, Su Zhen

机构信息

Medical Affairs, GlaxoSmithKline Canada, Mississauga, ON;

Medical Affairs, GlaxoSmithKline Canada, Mississauga, ON; ; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON;

出版信息

Can Urol Assoc J. 2014 Jan-Feb;8(1-2):E1-7. doi: 10.5489/cuaj.755.

DOI:10.5489/cuaj.755
PMID:24454593
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3896551/
Abstract

INTRODUCTION

We estimate the lifetime cost of treatment for moderate/severe symptoms associated with benign prostatic hyperplasia (BPH) in a cohort of Canadian men aged 50 to 59, and we evaluate the costs of 2 daily bioequivalent treatment options: fixed-dose combination (FDC) of dutasteride (0.5 mg) and tamsulosin (0.4 mg), or concomitant administration of dutasteride (0.5 mg) and tamsulosin (0.4 mg) monotherapies.

METHODS

The expected lifetime costs were estimated by modelling the incidence of acute urinary retention (AUR), BPH-related surgery and clinical progression over a patient's lifetime (up to 25 years). A model was developed to simulate clinical events over time, based on a discrete Markov process with 6 mutually exclusive health states and annual cycle length.

RESULTS

The estimated lifetime budget cost for the cohort of 374 110 men aged 50 to 59 in Canada is between $6.35 billion and $7.60 billion, equivalent to between $16 979 and $20 315 per patient with moderate/severe symptoms associated with BPH. Costs are lower for FDC treatment, with the net difference in lifetime budget impact between the 2 treatment regimens at $1.25 billion. In this analysis, the true costs of BPH in Canada are underestimated for 2 main reasons: (1) to make the analysis tractable, it is restricted to a cohort aged 50 to 59, whereas BPH can affect all men; and (2) a closed cohort approach does not include the costs of new (incident) cases.

CONCLUSION

Canadian clinical guidelines recommend the use of the combination of tamsulosin and dutasteride for men with moderate/severe symptoms associated with BPH and enlarged prostate volume. This analysis, using a representational patient group, suggests that the FDC is a more cost-effective treatment option for BPH.

摘要

引言

我们估算了加拿大50至59岁男性队列中与良性前列腺增生(BPH)相关的中度/重度症状的终身治疗成本,并评估了两种每日生物等效治疗方案的成本:度他雄胺(0.5毫克)和坦索罗辛(0.4毫克)的固定剂量组合(FDC),或度他雄胺(0.5毫克)和坦索罗辛(0.4毫克)单一疗法的联合给药。

方法

通过对急性尿潴留(AUR)、BPH相关手术的发生率以及患者一生中(长达25年)的临床进展进行建模,估算预期终身成本。基于具有6个相互排斥健康状态和年度周期长度的离散马尔可夫过程,开发了一个模型来模拟随时间推移的临床事件。

结果

加拿大374110名50至59岁男性队列的估算终身预算成本在63.5亿加元至76.0亿加元之间,相当于每位患有与BPH相关的中度/重度症状的患者16979加元至20315加元。FDC治疗的成本较低,两种治疗方案之间的终身预算影响净差异为12.5亿加元。在此分析中,加拿大BPH的实际成本被低估主要有两个原因:(1)为使分析易于处理,仅限于50至59岁的队列,而BPH可影响所有男性;(2)封闭队列方法不包括新(发病)病例的成本。

结论

加拿大临床指南建议,对于患有与BPH相关的中度/重度症状且前列腺体积增大的男性,使用坦索罗辛和度他雄胺联合治疗。本分析使用代表性患者组表明,FDC是BPH更具成本效益的治疗选择。

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2010 Update: Guidelines for the management of benign prostatic hyperplasia.2010年更新版:良性前列腺增生管理指南
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Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.具有长半衰期药物度他雄胺的部分阻断随机交叉生物等效性研究的操作特征:通过模拟研究和与最终结果比较进行的考察。
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