The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1‐84) : A retrospective cohort study
Abstract Objective This study assessed the risk of developing chronic kidney disease (CKD) and decline in estimated glomerular filtration rate (eGFR) over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1‐84) (rhPTH[1‐84]) compared with a historical control cohort of patients not treated with rhPTH(1‐84). Design Retrospective cohort study of patients with chronic hypoparathyroidism treated with rhPTH(1‐84) derived from the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) and HEXT (NCT01199614, and its continuation study NCT02910466) clinical trials and a historical control cohort who did not receive PTH selected from an electronic medical record database. Patients One hundred and eighteen patients treated with rhPTH(1‐84) and 497 patient controls. Measurements Incident CKD was defined as ≥2 eGFR measurements <60 ml/min/1.73 m2≥3 months apart during the study and a sustained eGFR decline of ≥30% from baseline. Results Over the 5‐year period, Kaplan–Meier analyses showed that rhPTH(1‐84)‐treated patients had a significantly lower risk of developing CKD (log‐rank p = .002) and a lower risk for a sustained eGFR decline ≥30% from baseline (log‐rank p < .001) compared with patients in the control cohort. In adjusted analyses, patients in the rhPTH(1‐84)‐treated cohort had a 53% lower risk of developing CKD (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.25–0.87) and a 65% lower risk for sustained eGFR decline ≥30% from baseline (HR, 0.35; 95% CI, 0.13–0.89) compared with controls. Conclusions Patients with chronic hypoparathyroidism treated with rhPTH(1‐84) in long‐term clinical trials had a significantly lower risk of developing CKD compared with patients in a historical control cohort not treated with rhPTH(1‐84)..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:98 |
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| Enthalten in: |
Clinical Endocrinology - 98(2023), 4, Seite 496-504 |
| Beteiligte Personen: |
Rejnmark, Lars [VerfasserIn] |
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| Anmerkungen: |
© 2023 John Wiley & Sons Ltd. |
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| Umfang: |
9 |
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| doi: |
10.1111/cen.14813 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Rejnmark, Lars |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1‐84) |b A retrospective cohort study |
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| 520 | |a Abstract Objective This study assessed the risk of developing chronic kidney disease (CKD) and decline in estimated glomerular filtration rate (eGFR) over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1‐84) (rhPTH[1‐84]) compared with a historical control cohort of patients not treated with rhPTH(1‐84). Design Retrospective cohort study of patients with chronic hypoparathyroidism treated with rhPTH(1‐84) derived from the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) and HEXT (NCT01199614, and its continuation study NCT02910466) clinical trials and a historical control cohort who did not receive PTH selected from an electronic medical record database. Patients One hundred and eighteen patients treated with rhPTH(1‐84) and 497 patient controls. Measurements Incident CKD was defined as ≥2 eGFR measurements <60 ml/min/1.73 m2≥3 months apart during the study and a sustained eGFR decline of ≥30% from baseline. Results Over the 5‐year period, Kaplan–Meier analyses showed that rhPTH(1‐84)‐treated patients had a significantly lower risk of developing CKD (log‐rank p = .002) and a lower risk for a sustained eGFR decline ≥30% from baseline (log‐rank p < .001) compared with patients in the control cohort. In adjusted analyses, patients in the rhPTH(1‐84)‐treated cohort had a 53% lower risk of developing CKD (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.25–0.87) and a 65% lower risk for sustained eGFR decline ≥30% from baseline (HR, 0.35; 95% CI, 0.13–0.89) compared with controls. Conclusions Patients with chronic hypoparathyroidism treated with rhPTH(1‐84) in long‐term clinical trials had a significantly lower risk of developing CKD compared with patients in a historical control cohort not treated with rhPTH(1‐84). | ||
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| 700 | 1 | |a Lax, Angela |4 aut | |
| 700 | 1 | |a Mu, Fan |4 aut | |
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| 700 | 1 | |a Gosmanova, Elvira O. |4 aut | |
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