Predictive factors requiring high-dose evocalcet in hemodialysis patients with secondary hyperparathyroidism

by Masanori Tokumoto, Shin Tokunaga, Shinji Asada, Yuichi Endo, Noriaki Kurita, Masafumi Fukagawa, Tadao Akizawa The dosage of evocalcet required to control serum parathyroid hormone (PTH) levels varies among secondary hyperparathyroidism (SHPT) patients. This post hoc analysis evaluated the dose-dependent efficacy of evocalcet on serum intact PTH (iPTH) levels, corrected calcium (Ca) and phosphate (P) level s, and safety, in an evaluation period (week 28 to week 30) by stratifying the previous phase 3 data with the final evocalcet dosages (low 1–2 mg [131 patients], medium 3–4 mg [90 patients], high 5–8 mg [92 patients]), and identified pre-treatment patient characteristics predicting the use of higher final evocalcet dosages via univariate and multivariate logistic regression models. At the end of the study at week 30, the median serum iPTH level was higher and the achievement ratio for the target range of Japanese Society for Dialysis Therapy (60–240 pg/mL) was lower in the final high-d ose subgroup (216 pg/mL and 58%, respectively) than in the other subgroups (low: 149 pg/mL and 79%; medium: 149 pg/mL and 73%, respectively). Among the three subgroups, the mean serum corrected Ca and P levels demonstrated similar trends, and similar ratio of patients achieved the target range (corr ected Ca, 8.4–10 mg/dL; P, 3.5–6.0 mg/dL) from week 28 to week 30. No dose-dependent safety concerns were identified. Younger age, prior cinacalcet use, higher serum levels of iPTH ...
Source: PLoS One - Category: Biomedical Science Authors: Source Type: research