Clinical Outcome of Etelcalcetide Therapy for Hyperparathyroidism in Hemodialysis Patients with Cinacalcet Intolerance

All cases were identified from Qatar’s national electronic medical records at HMC (CERNER Millennium Software is an electronic health record system used in Hamad Medical Corporation to manage patient information and clinical workflows) to retrieve the following data: demographic data (age, gender, dialysis treatment duration (vintage)), comorbidities, laboratory tests (collected as baseline for 3 months before initiation of etelcalcetide then monthly for the duration of the study) including PTH, calcium, phosphorus, and vitamin D levels and doses of medications related to MBD management such as phosphate binders, calcium supplements, vitamin D supplements, active vitamin D treatment. The primary outcome was the change in serum parathyroid hormone (PTH) level from baseline (defined as the last PTH measurement while on cinacalcet therapy) to the end of the observation period on etelcalcetide. The secondary outcomes included the:

time to full response, defined as the duration (in months) from the initiation of etelcalcetide therapy (baseline) to the measurement at which serum PTH fell below 600 pg/mL. Patients who did not reach this threshold during the study period were censored at their last available PTH result.
percentage of patients who experienced hypocalcemia (corrected serum calcium ≤ 2.0 mmol/L), and severe hypocalcemia (corrected calcium ≤ 1.8 mmol/L)
time to the first episode of hypocalcemia, defined as the duration from treatment initiation to the first occurrence of hypocalcemia (in months).
Files and variables
File: FINAL_DATA-EXPORT.xlsx
Description: Patients who received etelcalcetide in the State of Qatar between May 2021 and December 2023.

Variables
Demographic data (age, gender, dialysis treatment duration (vintage)).
Comorbidities.
Laboratory tests (collected as baseline for 3 months before initiation of etelcalcetide, then monthly for the duration of the study), including PTH, calcium, phosphorus, and vitamin D levels, and doses of medications related to MBD management, such as phosphate binders, calcium supplements, vitamin D supplements, and active vitamin D treatment.
Code/software
Continuous variables were summarized as means (SD) and standard deviations or medians (IQR), and categorical variables as frequencies and percentages. Comparison between baseline and end-of-study parameters was conducted using the t-test or Wilcoxon signed-rank test. Binary logistic regression was used to identify independent predictors of achieving a full biochemical response to etelcalcitide (PTH < 600 pg/mL) at any time during follow-up. The time-to-event (full response to etelcalcitide and first episode of hypocalcemia) analyses were analyzed using Kaplan–Meier survival curves. Predictors of these outcomes were explored using Cox proportional hazards regression, adjusting for baseline covariates. All tests were two-tailed, and a P value <0.05 was considered statistically significant.