Safety of Oral Bisphosphonates in Moderate-to-Severe Chronic Kidney Disease: A Binational Cohort Analysis
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- Danielle E Robinson
- Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
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- M Sanni Ali
- Department of Public Health Saint Paul Hospital Millennium Medical College Addis Ababa Ethiopia
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- Natalia Pallares
- Biostatistics Unit, Bellvitge Biomedical Research Institute (IDIBELL) L'Hospitalet de Llobregat Barcelona Spain
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- Cristian Tebé
- Basic Medical Sciences Department Rovira Virgili University Tarragona Spain
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- Leena Elhussein
- Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
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- Bo Abrahamsen
- Holbæk Hospital, Department of Medicine Holbæk Denmark
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- Nigel K Arden
- Sport, Exercise and Arthritis Centre: Versus Arthritis University of Oxford Oxford UK
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- Yoav Ben-Shlomo
- Population Health Sciences Bristol Medical School, University of Bristol Bristol UK
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- Fergus J Caskey
- North Bristol NHS Trust Bristol UK
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- Cyrus Cooper
- MRC Lifecourse Epidemiology Unit University of Southampton Southampton UK
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- Daniel Dedman
- Clinical Practice Research Datalink (CPRD) London UK
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- Antonella Delmestri
- Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
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- Andrew Judge
- Musculoskeletal Research Unit Translational Health Sciences, Bristol Medical School, University of Bristol Bristol UK
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- María José Pérez-Sáez
- Department of Nephrology Hospital del Mar Barcelona Spain
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- Julio Pascual
- Department of Nephrology Hospital del Mar Barcelona Spain
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- Xavier Nogues
- Hospital del Mar Institute of Medical Research Autonomous University of Barcelona Research Network on Frailty and Healthy Aging (CIBERFES) Instituto Carlos III Barcelona Spain
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- Adolfo Diez-Perez
- Internal Medicine, IMIM (Hospital del Mar Research Institute), Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES) Barcelona Spain
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- Victoria Y Strauss
- Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) University of Oxford Oxford UK
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- M Kassim Javaid
- NDORMS, University of Oxford Oxford UK
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- Daniel Prieto-Alhambra
- Grup de Recerca en Malalties Prevalents de l'Aparell Locomotor (GREMPAL) Research Group and CIBERFes, University Institute for Primary Care Research (IDIAP) Jordi Gol, Universitat Autonoma de Barcelona and Instituto de Salud Carlos III Barcelona Spain
抄録
<jats:title>ABSTRACT</jats:title> <jats:p>Bisphosphonates are the first-line treatment for preventing fractures in osteoporosis patients. However, their use is contraindicated or to be used with caution in chronic kidney disease (CKD) patients, primarily because of a lack of information about their safety and effectiveness. We aimed to investigate the safety of oral bisphosphonates in patients with moderate to severe CKD, using primary-care electronic records from two cohorts, CPRD GOLD (1997–2016) and SIDIAP (2007–2015) in the UK and Catalonia, respectively. Both databases were linked to hospital records. SIDIAP was also linked to end-stage renal disease registry data. Patients with CKD stages 3b to 5, based on two or more estimated glomerular filtration rate measurements less than 45 mL/min/1.73 m2, aged 40 years or older were identified. New bisphosphonate users were propensity score–matched with up to five non-users to minimize confounding within this population. Our primary outcome was CKD stage worsening (estimated glomerular filtration rate [eGFR] decline or renal replacement therapy). Secondary outcomes were acute kidney injury, gastrointestinal bleeding/ulcers, and severe hypocalcemia. Hazard ratios (HRs) were estimated using Cox regression and Fine and Gray sub-HRs were calculated for competing risks. We matched 2447 bisphosphonate users with 8931 non-users from CPRD and 1399 users with 6547 non-users from SIDIAP. Bisphosphonate use was associated with greater risk of CKD progression in CPRD (sub-HR [95% CI]: 1.14 [1.04, 1.26]) and SIDIAP (sub-HR: 1.15 [1.04, 1.27]). No risk differences were found for acute kidney injury, gastrointestinal bleeding/ulcers, or hypocalcemia. Hence, we can conclude a modest (15%) increased risk of CKD progression was identified in association with bisphosphonate use. No other safety concerns were identified. Our findings should be considered before prescribing bisphosphonates to patients with moderate to severe CKD. © 2020 The Authors. Journal of Bone and Mineral Research published byWiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).</jats:p>
収録刊行物
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- Journal of Bone and Mineral Research
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Journal of Bone and Mineral Research 36 (5), 820-832, 2020-12-01
Oxford University Press (OUP)