4.5 Article

Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study

期刊

ADVANCES IN THERAPY
卷 39, 期 11, 页码 5013-5024

出版社

SPRINGER
DOI: 10.1007/s12325-022-02292-1

关键词

Electronic health records; Glomerular filtration rate; Hypoparathyroidism; Parathyroid hormone; Retrospective cohort study; rhPTH(1-84)

资金

  1. Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA

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This study evaluated the changes in estimated glomerular filtration rate (eGFR) over a 5-year period in patients with chronic hypoparathyroidism treated with rhPTH(1-84). The results showed that long-term treatment with rhPTH(1-84) was associated with stable eGFR compared with a decline in eGFR in the control group. This suggests that rhPTH(1-84) may help preserve renal function and reduce the risk of long-term renal complications in patients with chronic hypoparathyroidism.
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 (R) 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 m(2) 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 m(2), whereas eGFR in the control cohort declined by 10.36 mL/min/1.73 m(2), after adjusting for baseline variables. The difference in eGFR slopes between the cohorts over 5 years was 1.37 mL/min/1.73 m(2) 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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