Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1–84)

Author:

Chen Kristina S1ORCID,Gosmanova Elvira O2,Curhan Gary C3,Ketteler Markus45,Rubin Mishaela6,Swallow Elyse7,Zhao Jing7,Wang Jessie7,Sherry Nicole1,Krasner Alan1,Bilezikian John P6

Affiliation:

1. Shire Human Genetic Therapies, Inc., Cambridge, Massachusetts (a Takeda company)

2. Division of Nephrology, Albany Medical College and Nephrology Section, Stratton VA Medical Center, Albany, New York

3. Renal Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

4. Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany

5. Department of Medicine Program, University of Split School of Medicine, Split, Croatia

6. Columbia University College of Physicians and Surgeons, New York, New York

7. Analysis Group Inc., Boston, Massachusetts

Abstract

Abstract Context Chronic hypoparathyroidism (HypoPT) is conventionally managed with oral calcium and active vitamin D. Recombinant human parathyroid hormone (1–84) (rhPTH[1–84]) is a therapy targeting the pathophysiology of HypoPT by replacing parathyroid hormone. Objective To compare changes in the estimated glomerular filtration rate (eGFR) in patients with chronic HypoPT receiving or not receiving rhPTH(1–84) during a 5-year period. Design/Setting A retrospective analysis of patients with chronic HypoPT treated with or without rhPTH(1–84). Patients Sixty-nine patients with chronic HypoPT from 4 open-label, long-term trials (NCT00732615, NCT01268098, NCT01297309, and NCT02910466) composed the rhPTH(1–84) cohort and 53 patients with chronic HypoPT not receiving rhPTH(1–84) from the Geisinger Healthcare Database (01/2004–06/2016) composed the historical control cohort. Interventions The rhPTH(1–84) cohort (N = 69) received rhPTH(1–84) therapy; the historical control cohort (N = 53) did not receive rhPTH(1–84). Main Outcome Measures Changes in eGFR from baseline during a 5-year follow-up were examined in multivariate regression analyses. Results At baseline, demographic characteristics and eGFR were similar between cohorts, though the proportions with diabetes and cardiac disorders were lower in the rhPTH(1–84) cohort. At the end of follow-up, mean eGFR increased by 2.8 mL/min/1.73 m2 in the rhPTH(1–84) cohort, while mean eGFR fell by 8.0 mL/min/1.73 m2 in the control cohort. In the adjusted model, the difference in the annual eGFR change between the rhPTH(1–84) cohort and the control cohort was 1.7 mL/min/1.73 m2 per year (P = 0.009). Conclusions Estimated glomerular filtration rate was preserved for over 5 years among patients with chronic HypoPT receiving rhPTH(1–84) treatment, contrasting with an eGFR decline among those not receiving rhPTH(1–84).

Funder

Shire Human Genetic Therapies, Inc.

Publisher

The Endocrine Society

Subject

Biochemistry (medical),Clinical Biochemistry,Endocrinology,Biochemistry,Endocrinology, Diabetes and Metabolism

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