Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis

Abstract Alendronate and raloxifene are among the most popular anti-osteoporosis medications. However, there is a lack of head-to-head comparative effectiveness studies comparing the two treatments. We conducted a retrospective large-scale multicenter study encompassing over 300 million patients acr...

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Autores principales:	Yeesuk Kim, Yuxi Tian, Jianxiao Yang, Vojtech Huser, Peng Jin, Christophe G. Lambert, Hojun Park, Seng Chan You, Rae Woong Park, Peter R. Rijnbeek, Mui Van Zandt, Christian Reich, Rohit Vashisht, Yonghui Wu, Jon Duke, George Hripcsak, David Madigan, Nigam H. Shah, Patrick B. Ryan, Martijn J. Schuemie, Marc A. Suchard
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/9ec8348b22c44c3fb31947b88319de26
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spelling	oai:doaj.org-article:9ec8348b22c44c3fb31947b88319de262021-12-02T15:39:39ZComparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis10.1038/s41598-020-68037-82045-2322https://doaj.org/article/9ec8348b22c44c3fb31947b88319de262020-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-020-68037-8https://doaj.org/toc/2045-2322Abstract Alendronate and raloxifene are among the most popular anti-osteoporosis medications. However, there is a lack of head-to-head comparative effectiveness studies comparing the two treatments. We conducted a retrospective large-scale multicenter study encompassing over 300 million patients across nine databases encoded in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The primary outcome was the incidence of osteoporotic hip fracture, while secondary outcomes were vertebral fracture, atypical femoral fracture (AFF), osteonecrosis of the jaw (ONJ), and esophageal cancer. We used propensity score trimming and stratification based on an expansive propensity score model with all pre-treatment patient characteritistcs. We accounted for unmeasured confounding using negative control outcomes to estimate and adjust for residual systematic bias in each data source. We identified 283,586 alendronate patients and 40,463 raloxifene patients. There were 7.48 hip fracture, 8.18 vertebral fracture, 1.14 AFF, 0.21 esophageal cancer and 0.09 ONJ events per 1,000 person-years in the alendronate cohort and 6.62, 7.36, 0.69, 0.22 and 0.06 events per 1,000 person-years, respectively, in the raloxifene cohort. Alendronate and raloxifene have a similar hip fracture risk (hazard ratio [HR] 1.03, 95% confidence interval [CI] 0.94–1.13), but alendronate users are more likely to have vertebral fractures (HR 1.07, 95% CI 1.01–1.14). Alendronate has higher risk for AFF (HR 1.51, 95% CI 1.23–1.84) but similar risk for esophageal cancer (HR 0.95, 95% CI 0.53–1.70), and ONJ (HR 1.62, 95% CI 0.78–3.34). We demonstrated substantial control of measured confounding by propensity score adjustment, and minimal residual systematic bias through negative control experiments, lending credibility to our effect estimates. Raloxifene is as effective as alendronate and may remain an option in the prevention of osteoporotic fracture.Yeesuk KimYuxi TianJianxiao YangVojtech HuserPeng JinChristophe G. LambertHojun ParkSeng Chan YouRae Woong ParkPeter R. RijnbeekMui Van ZandtChristian ReichRohit VashishtYonghui WuJon DukeGeorge HripcsakDavid MadiganNigam H. ShahPatrick B. RyanMartijn J. SchuemieMarc A. SuchardNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 10, Iss 1, Pp 1-10 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Yeesuk Kim Yuxi Tian Jianxiao Yang Vojtech Huser Peng Jin Christophe G. Lambert Hojun Park Seng Chan You Rae Woong Park Peter R. Rijnbeek Mui Van Zandt Christian Reich Rohit Vashisht Yonghui Wu Jon Duke George Hripcsak David Madigan Nigam H. Shah Patrick B. Ryan Martijn J. Schuemie Marc A. Suchard Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
description	Abstract Alendronate and raloxifene are among the most popular anti-osteoporosis medications. However, there is a lack of head-to-head comparative effectiveness studies comparing the two treatments. We conducted a retrospective large-scale multicenter study encompassing over 300 million patients across nine databases encoded in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The primary outcome was the incidence of osteoporotic hip fracture, while secondary outcomes were vertebral fracture, atypical femoral fracture (AFF), osteonecrosis of the jaw (ONJ), and esophageal cancer. We used propensity score trimming and stratification based on an expansive propensity score model with all pre-treatment patient characteritistcs. We accounted for unmeasured confounding using negative control outcomes to estimate and adjust for residual systematic bias in each data source. We identified 283,586 alendronate patients and 40,463 raloxifene patients. There were 7.48 hip fracture, 8.18 vertebral fracture, 1.14 AFF, 0.21 esophageal cancer and 0.09 ONJ events per 1,000 person-years in the alendronate cohort and 6.62, 7.36, 0.69, 0.22 and 0.06 events per 1,000 person-years, respectively, in the raloxifene cohort. Alendronate and raloxifene have a similar hip fracture risk (hazard ratio [HR] 1.03, 95% confidence interval [CI] 0.94–1.13), but alendronate users are more likely to have vertebral fractures (HR 1.07, 95% CI 1.01–1.14). Alendronate has higher risk for AFF (HR 1.51, 95% CI 1.23–1.84) but similar risk for esophageal cancer (HR 0.95, 95% CI 0.53–1.70), and ONJ (HR 1.62, 95% CI 0.78–3.34). We demonstrated substantial control of measured confounding by propensity score adjustment, and minimal residual systematic bias through negative control experiments, lending credibility to our effect estimates. Raloxifene is as effective as alendronate and may remain an option in the prevention of osteoporotic fracture.
format	article
author	Yeesuk Kim Yuxi Tian Jianxiao Yang Vojtech Huser Peng Jin Christophe G. Lambert Hojun Park Seng Chan You Rae Woong Park Peter R. Rijnbeek Mui Van Zandt Christian Reich Rohit Vashisht Yonghui Wu Jon Duke George Hripcsak David Madigan Nigam H. Shah Patrick B. Ryan Martijn J. Schuemie Marc A. Suchard
author_facet	Yeesuk Kim Yuxi Tian Jianxiao Yang Vojtech Huser Peng Jin Christophe G. Lambert Hojun Park Seng Chan You Rae Woong Park Peter R. Rijnbeek Mui Van Zandt Christian Reich Rohit Vashisht Yonghui Wu Jon Duke George Hripcsak David Madigan Nigam H. Shah Patrick B. Ryan Martijn J. Schuemie Marc A. Suchard
author_sort	Yeesuk Kim
title	Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
title_short	Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
title_full	Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
title_fullStr	Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
title_full_unstemmed	Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
title_sort	comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/9ec8348b22c44c3fb31947b88319de26
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Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis

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