Evaluating targets and costs of treatment for secondary hyperparathyroidism in incident dialysis patients: the FARO-2 study

Abstract

Background

The aim of this analysis was to estimate biochemical parameters and the costs of treatment of secondary hyperparathyroidism (SHPT) in a subpopulation of the FARO-2 study.

Methods

The FARO-2 observational study aimed at evaluating the patterns of treatment for SHPT in naïve hemodialysis patients. Data related to pharmacological treatments and biochemical parameters (parathyroid hormone [PTH], calcium, phosphate) were recorded at entry to hemodialysis (baseline) and 6 months later (second survey). The analysis was performed from the Italian National Health Service perspective.

Results

Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P<0.0001). At the second survey, the intravenous paricalcitol group showed a higher percentage of patients at target for PTH than in the oral calcitriol group without changing the percentage of patients at target for phosphate. Moreover, between baseline and the second survey, intravenous paricalcitol significantly increased both the percentage of patients at target for PTH (P=0.033) and the percentage of patients at target for the combined endpoint PTH, calcium, and phosphate (P=0.001). The per-patient weekly pharmaceutical costs related to SHPT treatment, erythropoietin-stimulating agents and phosphate binders accounted for 186.32€ and 219.94€ at baseline for oral calcitriol and intravenous paricalcitol, respectively, while after 6 months, the costs were 180.51€ and 198.79€, respectively. Either at the beginning of dialysis or 6 months later, the total cost of SHPT treatment was not significantly lower in the oral calcitriol group compared with the intravenous paricalcitol group, with a difference among groups that decreased by 46% between the two observations. The cost of erythropoietin stimulating agents at the second survey was lower (−22%) in the intravenous paricalcitol group than in the oral calcitriol group (132.13€ versus 168.36€, respectively).

Conclusion

Intravenous paricalcitol significantly increased the percentage of patients at target for the combined endpoint of PTH, calcium, and phosphate (P=0.001). The total cost of treatment for the patients treated with intravenous paricalcitol 6 months after entry to dialysis was not significantly higher than the cost for patients treated with oral calcitriol.

Keywords:

• cost consequences analysis
• therapeutic costs
• outcomes
• SHPT treatments
• secondary hyperparathyroidism

Author contributions

All the authors conceived and performed the present analysis and have written the manuscript.

Disclosure

An abstract reporting the preliminary results of this study was presented as a poster at the 49th European Renal Association-European Dialysis and Transplant Association Congress, May 24–27, 2012, Paris, France. The design, study conduct, and financial support for the clinical trial was provided by AbbVie. AbbVie participated in interpretation of the data, review, and approval of the manuscript.

Daniela Paola Roggeri is a consultant for AbbVie. Piergiorgio Messa is a member of the FARO Steering Committee, and has received lecture honoraria from Janssen Cilag, and Amgen. Mario Cozzolino is a member of the FARO Steering Committee, and has received lecture honoraria from AbbVie, Shire, Amgen, Sanofi/Genzyme, Vifor-Fresenius, and Roche. Diego Brancaccio is a member of the FARO Steering Committee, is a consultant for Abbott, and has received lecture honoraria from GSK, Amgen, and Shire. Ernesto Paoletti is a consultant for and has received honoraria from AbbVie, Novartis, and Janssen-Cilag. Alessandro Roggeri is a consultant for AbbVie. Anna Maria Costanzo is a Head of Medical Affairs SH, for AbbVie Italy. Umberto di Luzio Paparatti is an Affiliate Medical Director for AbbVie, Italy. Vincenzo Festa is a Medical Manager for AbbVie Italy. Sandro Mazzaferro is a member of the FARO Steering Committee, and has received lecture honoraria from Shire and Amgen.