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논문분류	춘계학술대회 초록집
제목	Comparison Of Evocalcet With Cinacalcet In East Asian Patients With Severe Secondary Hyperparathyroidism Undergoing Hemodialysis: A Post-Hoc Analysis Of ORCHESTRA Study
저자	Tak Mao Daniel Chan
출판정보	2024; 2024(1):
키워드
초록	Objectives: The ORCHESTRA study showed that evocalcet was non-inferior to cinacalcet when orally administered once daily for 52 weeks in East Asian patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis. We conducted a post-hoc analysis to investigate outcomes in the subgroup of ORCHESTRA study subjects with severe SHPT (>500 pg/mL) at inclusion. Methods: This post hoc analysis used data of patients with severe SHPT in the ORCHESTRA trial, a randomized, double-blind, parallel-group study comparing evocalcet with cinacalcet. The primary endpoint was mean percent change in intact parathyroid hormone (iPTH) level from baseline in the evaluation period (weeks 50 to 52) and the percent ratio to baseline in intact PTH level at week 20, week 40 and last visit. The primary efficacy variable was analyzed by descriptive statistics and 95% CI for mean of percent change values; percent ratio to baseline at last visit was compared between evocalcet and cinacalcet with t-test and analyzed the trajectories of each group parameter using a repeated measures ANCOVA model. Results: A total of 146 patients were included in evocalcet arm and 131 in the cinacalcet arm (52.7% and 47.3% of the study population, respectively). Mean patient age was 51.5 and 50.9 years, and mean baseline iPTH, 924.05 pg/mL and 1022.84 pg/mL, respectively. The percent ratio of intact PTH level reduction compared with baseline was statistically significant (table 1). Also, the weekly iPTH level curves of evocalcet and cinacalcet started to separate from week 32 onwards (Figure 1).The incidence of upper gastrointestinal tract related ADRs was lower in the evocalcet group (29.9%) than the cinacalcet group (50%). Conclusions: Notwithstanding the limitations of post hoc analysis, these results demonstrate increased efficacy and safety of evocalcet in the treatment of hemodialysis patients with severe SHPT, as compared with cinacalcet.
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