Recent changes in therapeutic approaches and association with outcomes among patients with secondary hyperparathyroidism on chronic hemodialysis: the DOPPS study.

Abstract

BACKGROUND AND OBJECTIVES:

Elevated parathyroid hormone levels may be associated with adverse clinical outcomes in patients on dialysis. After the introduction of practice guidelines suggesting higher parathyroid hormone targets than those previously recommended, changes in parathyroid hormone levels and treatment regimens over time have not been well documented.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:

Using data from the international Dialysis Outcomes and Practice Patterns Study, trends in parathyroid hormone levels and secondary hyperparathyroidism therapies over the past 15 years and the associations between parathyroid hormone and clinical outcomes are reported; 35,655 participants from the Dialysis Outcomes and Practice Patterns Study phases 1-4 (1996-2011) were included.

RESULTS:

Median parathyroid hormone increased from phase 1 to phase 4 in all regions except for Japan, where it remained stable. Prescriptions of intravenous vitamin D analogs and cinacalcet increased and parathyroidectomy rates decreased in all regions over time. Compared with 150-300 pg/ml, in adjusted models, all-cause mortality risk was higher for parathyroid hormone=301-450 (hazard ratio, 1.09; 95% confidence interval, 1.01 to 1.18) and >600 pg/ml (hazard ratio, 1.23; 95% confidence interval, 1.12 to 1.34). Parathyroid hormone >600 pg/ml was also associated with higher risk of cardiovascular mortality as well as all-cause and cardiovascular hospitalizations. In a subgroup analysis of 5387 patients not receiving vitamin D analogs or cinacalcet and with no prior parathyroidectomy, very low parathyroid hormone (<50 pg/ml) was associated with mortality (hazard ratio, 1.25; 95% confidence interval, 1.04 to 1.51).

CONCLUSIONS:

In a large international sample of patients on hemodialysis, parathyroid hormone levels increased in most countries, and secondary hyperparathyroidism treatments changed over time. Very low and very high parathyroid hormone levels were associated with adverse outcomes. In the absence of definitive evidence in support of a specific parathyroid hormone target, there is an urgent need for additional research to inform clinical practice.

• Authors: Francesca Tentori, Mia Wang, Brian A Bieber, Angelo Karaboyas, Yun Li, Stefan H Jacobson, Vittorio E Andreucci, Masafumi Fukagawa, Luc Frimat, David C Mendelssohn, Friedrich K Port, Ronald L Pisoni, Bruce M Robinson
• Journal: Clinical journal of the American Society of Nephrology : CJASN (Clin J Am Soc Nephrol) Vol. 10 Issue 1 Pg. 98-109 (Jan 07 2015) ISSN: 1555-905X [Electronic] United States
• PMID: 25516917 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 by the American Society of Nephrology.

Chemical References

• Biomarkers
• Calcimimetic Agents
• Naphthalenes
• PTH protein, human
• Parathyroid Hormone
• Vitamin D
• Cinacalcet

Topics

• Adult
• Aged
• Biomarkers (blood)
• Calcimimetic Agents (adverse effects, therapeutic use)
• Cinacalcet
• Dietary Supplements (adverse effects)
• Female
• Humans
• Hyperparathyroidism, Secondary (blood, diagnosis, etiology, mortality, therapy)
• Male
• Middle Aged
• Naphthalenes (adverse effects, therapeutic use)
• Parathyroid Hormone (blood)
• Parathyroidectomy (adverse effects, mortality, trends)
• Prospective Studies
• Renal Dialysis (adverse effects, mortality)
• Renal Insufficiency, Chronic (blood, complications, diagnosis, mortality, therapy)
• Risk Assessment
• Risk Factors
• Time Factors
• Treatment Outcome
• Up-Regulation
• Vitamin D (adverse effects, therapeutic use)