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Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.
Ayodele, Olulade; Rejnmark, Lars; Mu, Fan; Lax, Angela; Berman, Richard; Swallow, Elyse; Gosmanova, Elvira O.
Afiliação
  • Ayodele O; Takeda Pharmaceuticals USA, Inc., 55 Hayden Ave, Lexington, MA, 02420, USA. Lade.ayodele@takeda.com.
  • Rejnmark L; Aarhus University and Aarhus University Hospital, Aarhus, Denmark.
  • Mu F; Analysis Group, Inc., Boston, MA, USA.
  • Lax A; Analysis Group, Inc., Boston, MA, USA.
  • Berman R; Analysis Group, Inc., Boston, MA, USA.
  • Swallow E; Analysis Group, Inc., Boston, MA, USA.
  • Gosmanova EO; Albany Medical College, Albany, NY, USA.
Adv Ther ; 39(11): 5013-5024, 2022 11.
Article em En | MEDLINE | ID: mdl-36018496
INTRODUCTION: Chronic hypoparathyroidism is associated with higher risk of developing chronic kidney disease compared with the general population. This study evaluated changes in estimated glomerular filtration rate (eGFR) over a 5-year period in adult patients with chronic hypoparathyroidism treated with recombinant parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients who did not receive rhPTH(1-84). METHODS: This retrospective cohort study included patients with chronic hypoparathyroidism treated with rhPTH(1-84) in the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309), and HEXT (NCT01199614 and continuation study NCT02910466) clinical trials. A historical control cohort who did not receive parathyroid hormone but who had enrollment criteria similar to those for the clinical trials was selected from the IBM® Explorys electronic medical record database (January 2007-August 2019). Outcomes of interest were the annual rate of change in eGFR from baseline (i.e., eGFR slope) and the predicted eGFR change from baseline at years 1 through 5. RESULTS: The study comprised 72 adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) and 176 control patients who did not receive rhPTH(1-84). Over 5 years, eGFR remained stable in the rhPTH(1-84) cohort, whereas eGFR declined at a rate of 1.67 mL/min/1.73 m2 per year in the control cohort (P < 0.001 for eGFR slope in the control cohort). At 5 years, predicted eGFR in the rhPTH(1-84) cohort increased from baseline by 1.21 mL/min/1.73 m2, whereas eGFR in the control cohort declined by 10.36 mL/min/1.73 m2, after adjusting for baseline variables. The difference in eGFR slopes between the cohorts over 5 years was 1.37 mL/min/1.73 m2 per year (95% CI 0.62-2.13; P < 0.001). CONCLUSION: Long-term treatment with rhPTH(1-84) was associated with stable eGFR compared with eGFR decline in the controls not treated with rhPTH(1-84). Preservation of renal function conferred by rhPTH(1-84) may benefit patients with chronic hypoparathyroidism by reducing risk of long-term renal complications.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cálcio / Hipoparatireoidismo Tipo de estudo: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cálcio / Hipoparatireoidismo Tipo de estudo: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article