TY - JOUR
T1 - Pattern of Laboratory Parameters and Management of Secondary Hyperparathyroidism in Countries of Europe, Asia, the Middle East, and North America
AU - Cozzolino, Mario
AU - Shilov, Eugeniy
AU - Li, Zuo
AU - Fukagawa, Masafumi
AU - Al-Ghamdi, Saeed M.G.
AU - Pisoni, Ronald
AU - Bieber, Brian
AU - Vallabh, Bhadrish
AU - Chand, Deepa H.
N1 - Funding Information:
Medical writing assistance, funded by AbbVie, was provided by Michael J. Theisen, PhD, and Janet E. Matsuura, PhD, of Complete Publication Solutions, LLC (North Wales, PA), a CHC Group company.
Funding Information:
Global support for the ongoing DOPPS Programs is provided without restriction on publications. See https://www.dopps.org/AboutUs/Support.aspx for more information. AbbVie and the authors thank the patients and all study investigators for their contributions. The DOPPS program and Arbor Research Collaborative for Health were paid by AbbVie to conduct the analyses; authors from Arbor were not compensated for their time spent in their authorship role. AbbVie Inc. participated in the study design, research, interpretation of data, reviewing, and approval of the publication, and funded the journal?s rapid service and open access fees. Medical writing assistance, funded by AbbVie, was provided by Michael J. Theisen, PhD, and Janet E. Matsuura, PhD, of Complete Publication Solutions, LLC (North Wales, PA), a CHC Group company. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. All authors were involved in the design or conception of the work or in data acquisition or interpretation, contributed important intellectual content during manuscript drafting or revision, and approved the final version. Each author accepts personal accountability for his or her own contributions, and agrees to ensure that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. Mario Cozzolino has received consulting fees from AbbVie, Amgen, Shire, Baxter, and Vifor; and grants from AbbVie, Shire, Baxter, and Keryx. Masafumi Fukagawa has received consulting fees from Kyowa-Hakko Kirin and Ono Pharmaceutical; lecture fees from Kyowa-Hakko Kirin, Bayer Japan, Torii Pharmaceutical, and Ono Pharmaceutical; and grants from Kyowa-Hakko Kirin and Bayer Japan. Saeed M.G. Al-Ghamdi has received lecture fees and travel support from AbbVie and Amgen and research grants from Sanofi. Bhadrish Vallabh is an employee and shareholder of AbbVie Inc. Deepa H. Chand is a former employee and shareholder of AbbVie Inc. Her current affiliation is AveXis, Inc., Bannockburn, IL. Eugeniy Shilov, Zuo Li, Ronald Pisoni, and Brian Bieber have nothing to disclose. The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. The study was approved by a central Institutional Review Board in the USA (Ethical & Independent Review Services). Outside of the USA, copies of IRB approvals and/or exemptions were obtained for each participating study site. Additional study approval and patient consent were obtained as required by national and local ethics committee regulations. All data generated or analyzed during this study are included in this article.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Introduction: This analysis explored laboratory mineral and bone disorder parameters and management of secondary hyperparathyroidism in patients undergoing hemodialysis in Belgium, Canada, China, France, Germany, Italy, Japan, Russia, Saudi Arabia, Spain, Sweden, the UK, and the USA. Methods: Analyses used demographic, medication, and laboratory data collected in the prospective Dialysis Outcomes and Practice Patterns Study (2012–2015). The analysis included 20,612 patients in 543 facilities. Descriptive data are presented as regional mean (standard deviation), median (interquartile range), or prevalence, weighted for facility sampling fraction. No testing of statistical hypotheses was conducted. Results: The frequency of serum intact parathyroid hormone levels > 600 pg/mL was lowest in Japan (1%) and highest in Russia (30%) and Saudi Arabia (27%). The frequency of serum phosphorus levels > 7.0 mg/dL was lowest in France (4%), the UK (6%), and Spain (6%), and highest in China (27%). The frequency of serum calcium levels > 10.0 mg/dL was highest in the UK (14%) and China (13%) versus 2% to 9% elsewhere. Dialysate calcium concentrations of 2.5 mEq/mL were common in the USA (78%) and Canada (71%); concentrations of 3.0–3.5 mEq/L were almost universal at facilities in Italy, France, and Saudi Arabia (each ≥ 99%). Conclusions: Wide international variation in mineral and bone disorder laboratory parameters and management practices related to secondary hyperparathyroidism suggests opportunities for optimizing care.
AB - Introduction: This analysis explored laboratory mineral and bone disorder parameters and management of secondary hyperparathyroidism in patients undergoing hemodialysis in Belgium, Canada, China, France, Germany, Italy, Japan, Russia, Saudi Arabia, Spain, Sweden, the UK, and the USA. Methods: Analyses used demographic, medication, and laboratory data collected in the prospective Dialysis Outcomes and Practice Patterns Study (2012–2015). The analysis included 20,612 patients in 543 facilities. Descriptive data are presented as regional mean (standard deviation), median (interquartile range), or prevalence, weighted for facility sampling fraction. No testing of statistical hypotheses was conducted. Results: The frequency of serum intact parathyroid hormone levels > 600 pg/mL was lowest in Japan (1%) and highest in Russia (30%) and Saudi Arabia (27%). The frequency of serum phosphorus levels > 7.0 mg/dL was lowest in France (4%), the UK (6%), and Spain (6%), and highest in China (27%). The frequency of serum calcium levels > 10.0 mg/dL was highest in the UK (14%) and China (13%) versus 2% to 9% elsewhere. Dialysate calcium concentrations of 2.5 mEq/mL were common in the USA (78%) and Canada (71%); concentrations of 3.0–3.5 mEq/L were almost universal at facilities in Italy, France, and Saudi Arabia (each ≥ 99%). Conclusions: Wide international variation in mineral and bone disorder laboratory parameters and management practices related to secondary hyperparathyroidism suggests opportunities for optimizing care.
KW - Bone mineral density
KW - CKD
KW - Dialysis
KW - ESRD
KW - Hyperparathyroidism
KW - Mineral metabolism
UR - http://www.scopus.com/inward/record.url?scp=85084792133&partnerID=8YFLogxK
U2 - 10.1007/s12325-020-01359-1
DO - 10.1007/s12325-020-01359-1
M3 - Article
C2 - 32410164
AN - SCOPUS:85084792133
SN - 0741-238X
VL - 37
SP - 2748
EP - 2762
JO - Advances in Therapy
JF - Advances in Therapy
IS - 6
ER -