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瑞典环境下雷奈酸锶治疗骨质疏松症的经济学评估:基于SOTI和TROPOS试验结果

An economic evaluation of strontium ranelate in the treatment of osteoporosis in a Swedish setting: based on the results of the SOTI and TROPOS trials.

作者信息

Borgström F, Jönsson B, Ström O, Kanis J A

机构信息

Stockholm Health Economics, Vasagatan 38, 2nd floor, SE-111 21 Stockholm, Sweden.

出版信息

Osteoporos Int. 2006 Dec;17(12):1781-93. doi: 10.1007/s00198-006-0193-z. Epub 2006 Sep 29.

DOI:10.1007/s00198-006-0193-z
PMID:17009083
Abstract

INTRODUCTION

Strontium ranelate is a new therapy for the treatment and prevention of osteoporosis that has been shown in two phase III clinical trials (the Spinal Osteoporosis Therapeutic Intervention [SOTI] and the Treatment Of Peripheral OSteoporosis Study [TROPOS] trials) to reduce the risk of osteoporotic fractures at the vertebral, non-vertebral and hip level in postmenopausal women. The aim of this study was to estimate the potential cost-effectiveness of strontium ranelate in the treatment of osteoporosis in postmenopausal Swedish patients.

METHODS

A Markov cohort model was adapted to fit patients corresponding to the patients in the SOTI and TROPOS clinical trials. The model was populated with Swedish cost and epidemiological data. In the base case, the cost-effectiveness was estimated for 69-year old women with low bone mineral density (BMD) and prevalent vertebral fractures (SOTI) and for 77-year old women with low BMD (TROPOS). The cost-effectiveness analysis had a societal perspective.

RESULTS

In the base case analysis, the cost per quality-adjusted life years (QALY) gained of strontium ranelate patients compared to no treatment patients was estimated at SEK 472,586 and SEK 259,643, including costs in added life years, based on the SOTI and the TROPOS trials, respectively. Excluding cost in added life years, the cost per QALY gained was estimated at SEK 336,420 (SOTI) and SEK 165,680 (TROPOS). In subgroup analyses, in patients 74 years and older with a T-score lower than -2.4 and patients older than 80 years of age, strontium ranelate was found to be cost saving compared to no treatment.

CONCLUSIONS

The results in the base case analyses and the sensitivity analyses of this study indicate that, compared to no treatment, strontium ranelate is cost-effective in the treatment of postmenopausal women with low BMD.

摘要

引言

雷奈酸锶是一种用于治疗和预防骨质疏松症的新疗法,两项III期临床试验(脊柱骨质疏松治疗干预[SOTI]试验和外周骨质疏松治疗研究[TROPOS]试验)已表明,雷奈酸锶可降低绝经后女性椎骨、非椎骨和髋部骨质疏松性骨折的风险。本研究的目的是评估雷奈酸锶治疗瑞典绝经后骨质疏松症患者的潜在成本效益。

方法

采用马尔可夫队列模型,使其符合SOTI和TROPOS临床试验中的患者情况。该模型纳入了瑞典的成本和流行病学数据。在基础病例中,对骨密度低且有椎体骨折病史的69岁女性(SOTI)以及骨密度低的77岁女性(TROPOS)的成本效益进行了评估。成本效益分析采用社会视角。

结果

在基础病例分析中,根据SOTI和TROPOS试验,与未治疗患者相比,雷奈酸锶治疗患者每获得一个质量调整生命年(QALY)的成本估计分别为472,586瑞典克朗和259,643瑞典克朗,包括延长生命年的成本。不包括延长生命年的成本,每获得一个QALY的成本估计为336,420瑞典克朗(SOTI)和165,680瑞典克朗(TROPOS)。在亚组分析中,对于年龄在74岁及以上、T值低于-2.4的患者以及80岁以上的患者,发现与未治疗相比,雷奈酸锶具有成本节约效益。

结论

本研究的基础病例分析和敏感性分析结果表明,与未治疗相比,雷奈酸锶治疗骨密度低的绝经后女性具有成本效益。

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