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Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4.
Am J Kidney Dis. 2004 May; 43(5):877-90.AJ

Abstract

BACKGROUND

Calcitriol lowers parathyroid hormone (PTH) levels in patients with chronic kidney disease (CKD) stages 3 and 4, but its use is limited by a low therapeutic index and concerns regarding hypercalcemia and acceleration of kidney disease. We evaluated doxercalciferol (1alpha-hydroxyvitamin D2) as an alternative therapy in a randomized, double-blinded, placebo-controlled, multicenter trial.

METHODS

Fifty-five adults with stage 3 or 4 CKD and an intact PTH (iPTH) level greater than 85 pg/mL (ng/L) completed 8 baseline weeks, followed by 24 weeks of oral therapy with doxercalciferol or placebo. Pretreatment demographics and biochemical features did not differ between groups. Dosages were increased gradually if iPTH level was not decreased by 30% or greater and serum calcium and phosphorus levels were stable. Regular monitoring included plasma iPTH, serum calcium and phosphorus, urinary calcium, bone-specific serum markers, and serum lalpha,25-dihydroxyvitamin D levels. Glomerular filtration rate (GFR) was measured before and after treatment.

RESULTS

Mean plasma iPTH level decreased by 46% from baseline after 24 weeks of doxercalciferol treatment (P <0.001), but was unchanged with placebo. After 6 weeks, iPTH level reductions with doxercalciferol treatment exceeded those with placebo at all subsequent intervals (P <0.001). No clinically significant differences in mean serum calcium or phosphorus or urinary calcium levels or incidence of hypercalcemia, hyperphosphatemia, or hypercalciuria were noted between groups. Serum C- and N-telopeptide and bone-specific alkaline phosphatase levels decreased with doxercalciferol treatment relative to both baseline and placebo (P <0.01). Adverse-event rates and changes in GFR did not differ between groups.

CONCLUSION

Doxercalciferol is safe and effective in controlling secondary hyperparathyroidism of patients with CKD stages 3 and 4.

Authors+Show Affiliations

West Los Angeles Veterans Affairs Healthcare Center, Los Angeles, CA 90073, USA. jack.coburn@med.va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15112179

Citation

Coburn, Jack W., et al. "Doxercalciferol Safely Suppresses PTH Levels in Patients With Secondary Hyperparathyroidism Associated With Chronic Kidney Disease Stages 3 and 4." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 43, no. 5, 2004, pp. 877-90.
Coburn JW, Maung HM, Elangovan L, et al. Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. Am J Kidney Dis. 2004;43(5):877-90.
Coburn, J. W., Maung, H. M., Elangovan, L., Germain, M. J., Lindberg, J. S., Sprague, S. M., Williams, M. E., & Bishop, C. W. (2004). Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 43(5), 877-90.
Coburn JW, et al. Doxercalciferol Safely Suppresses PTH Levels in Patients With Secondary Hyperparathyroidism Associated With Chronic Kidney Disease Stages 3 and 4. Am J Kidney Dis. 2004;43(5):877-90. PubMed PMID: 15112179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. AU - Coburn,Jack W, AU - Maung,Hla M, AU - Elangovan,Logan, AU - Germain,Michael J, AU - Lindberg,Jill S, AU - Sprague,Stuart M, AU - Williams,Mark E, AU - Bishop,Charles W, PY - 2004/4/28/pubmed PY - 2004/7/24/medline PY - 2004/4/28/entrez SP - 877 EP - 90 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 43 IS - 5 N2 - BACKGROUND: Calcitriol lowers parathyroid hormone (PTH) levels in patients with chronic kidney disease (CKD) stages 3 and 4, but its use is limited by a low therapeutic index and concerns regarding hypercalcemia and acceleration of kidney disease. We evaluated doxercalciferol (1alpha-hydroxyvitamin D2) as an alternative therapy in a randomized, double-blinded, placebo-controlled, multicenter trial. METHODS: Fifty-five adults with stage 3 or 4 CKD and an intact PTH (iPTH) level greater than 85 pg/mL (ng/L) completed 8 baseline weeks, followed by 24 weeks of oral therapy with doxercalciferol or placebo. Pretreatment demographics and biochemical features did not differ between groups. Dosages were increased gradually if iPTH level was not decreased by 30% or greater and serum calcium and phosphorus levels were stable. Regular monitoring included plasma iPTH, serum calcium and phosphorus, urinary calcium, bone-specific serum markers, and serum lalpha,25-dihydroxyvitamin D levels. Glomerular filtration rate (GFR) was measured before and after treatment. RESULTS: Mean plasma iPTH level decreased by 46% from baseline after 24 weeks of doxercalciferol treatment (P <0.001), but was unchanged with placebo. After 6 weeks, iPTH level reductions with doxercalciferol treatment exceeded those with placebo at all subsequent intervals (P <0.001). No clinically significant differences in mean serum calcium or phosphorus or urinary calcium levels or incidence of hypercalcemia, hyperphosphatemia, or hypercalciuria were noted between groups. Serum C- and N-telopeptide and bone-specific alkaline phosphatase levels decreased with doxercalciferol treatment relative to both baseline and placebo (P <0.01). Adverse-event rates and changes in GFR did not differ between groups. CONCLUSION: Doxercalciferol is safe and effective in controlling secondary hyperparathyroidism of patients with CKD stages 3 and 4. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/15112179/Doxercalciferol_safely_suppresses_PTH_levels_in_patients_with_secondary_hyperparathyroidism_associated_with_chronic_kidney_disease_stages_3_and_4_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272638604001416 DB - PRIME DP - Unbound Medicine ER -