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A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney
Sharon M Moe1, Akber Saifullah, Robert E LaClair
1Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. smoe@iupui.edu
Insights
Doxercalciferol showed a within-group reduction in parathyroid hormone (PTH) for chronic kidney disease patients. However, no significant difference was found compared to cholecalciferol, indicating a need for further research.
Area of Science:
- Nephrology
- Endocrinology
- Pharmacology
Background:
- Secondary hyperparathyroidism is common in chronic kidney disease (CKD).
- Optimal treatment for secondary hyperparathyroidism in CKD remains unclear.
- Vitamin D deficiency is prevalent in CKD patients.
Purpose of the Study:
- To compare the efficacy of doxercalciferol and cholecalciferol in treating secondary hyperparathyroidism in CKD patients.
- To evaluate the impact of these treatments on parathyroid hormone (PTH) levels.
- To assess effects on mineral metabolism and other clinical outcomes.
Main Methods:
- A 3-month randomized, blinded trial was conducted.
- Participants included vitamin D-deficient CKD stages 3-4 patients with elevated PTH.
- Cholecalciferol (n=22) was compared to doxercalciferol (n=25).
Main Results:
- Vitamin D levels significantly increased with cholecalciferol but not doxercalciferol.
- PTH levels decreased in the doxercalciferol group (P=0.002) but not significantly in the cholecalciferol group (P=0.16).
- No significant difference in PTH reduction was observed between the two treatment groups (P=0.11).
Conclusions:
- Doxercalciferol demonstrated a within-group reduction in PTH.
- No significant difference in efficacy was found between doxercalciferol and cholecalciferol.
- Larger, long-term studies are required to confirm efficacy and safety for mineral and non-mineral endpoints.
Background And Objectives:
The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown.
Design, Setting, Participants, & Measurements:
We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 microg/d; n = 25).
Results:
There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 +/- 6 to 37 +/- 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% +/- 34% in the doxercalciferol group (P = 0.002) and decreased by 10% +/- 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance.
Conclusions:
This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.
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