This study evaluated risk of chronic kidney disease (CKD) outcomes over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (184), rhPTH(184), compared with a historical control cohort of patients who did not receive rhPTH(184). The cohort of patients with chronic hypoparathyroidism treated with rhPTH(184) was derived from the NCT00732615 (REPLACE), NCT01268098 (RELAY), NCT01297309 (RACE) and NCT01199614 (HEXT) clinical trials. The control cohort of adult patients who did not receive rhPTH(184) or rhPTH(134) was selected from the US Explorys electronic medical record database (Jan 2007-Aug 2019), using criteria similar to the enrolment criteria used in the trials. Index date was the day after treatment initiation for the rhPTH(184) cohort, and the day after the first calcitriol prescription for the control cohort. Patients with CKD at baseline (defined as estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m2 at the closest eGFR measurement before the index date) were excluded. All included patients had ≥1 eGFR measurement within 6 months before the index date and ≥2 eGFR measurements ≥3 months apart during the 5 years on or after the index date. The CKD outcome was defined as first occurrence of eGFR <60 ml/min/1.73 m2 confirmed by a second measurement ≥3 months after. Risk of CKD was assessed in a KaplanMeier analysis and a Cox proportional hazards model adjusted for demographic characteristics, baseline clinical conditions, and baseline laboratory measurements. The analysis included 118 patients in the rhPTH(184) cohort and 478 patients in the control cohort. Patients in the rhPTH(184) cohort, compared with patients in the control cohort, were younger (mean±S.D. age, 45.3±11.4 vs 51.5±16.2 years; P <0.001) and a lower proportion had acute manifestations of hypoparathyroidism before the index date (15.3% vs 73.2%; P <0.001). In KaplanMeier analysis, rhPTH(184)-treated patients had a significantly reduced risk of developing CKD during follow-up compared with patients in the control cohort (11.0% vs 27.0%; P <0.01). The adjusted hazard ratio of developing CKD associated with rhPTH(184) treatment vs no rhPTH(184) treatment was 0.47 (95% CI, 0.25-0.88; P <0.05). Patients with chronic hypoparathyroidism treated with rhPTH(184) in long-term clinical trials had a significantly reduced risk of developing CKD compared with patients in a control cohort who did not receive rhPTH(184). These results should be viewed in light of possible treatment differences in the studied cohorts (ie, predefined trial protocols vs real-word practice for the control cohort).
Encore abstract from ENDO 2021.
22 May 2021 - 26 May 2021