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

Abstract

BackgroundThe 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.MethodsThe 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.ResultsTwo 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).ConclusionIntravenous 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.

Conversion from Intravenous Vitamin D Analogs to Oral Calcitriol in Patients Receiving Maintenance Hemodialysis

“…In the United States, IV vitamin D became the primary route of administration for management of secondary hyperparathyroidism in patients receiving maintenance dialysis after reports that, in contrast to oral administration, IV administration was associated with fewer episodes of hypercalcemia and hyperphosphatemia, better adherence, and improved bone outcomes (1,2). Other studies evaluating the efficacy of oral versus IV vitamin D examined primarily short-term treatment effects and found no differences in iPTH levels (1,4,5,7,8). A recent study examined the efficacy and safety of patients on maintenance hemodialysis previously receiving IV paricalcitol who then switched to oral calcitriol (9).…”

“…At 5 months, the mineral and bone disorder parameters were comparable with levels that had been achieved before the switch. Finally, some longer-term studies have suggested that parenteral therapies were associated with improved outcomes (1,7,8). Limitations of past studies included small sample sizes, short-term follow-up, and importantly, inclusion of patients who at baseline were already being treated differently.…”

Successful Conversion From Parenteral Paricalcitol to Pulse Oral Calcitriol for the Management of Secondary Hyperparathyroidism in Hemodialysis Patients

“…There is little published data looking at the efficacy and tolerability of oral calcitriol in the calcimimetic era to manage secondary hyperparathyroidism in hemodialysis patients and no information regarding real practice-based experience of such a treatment regimen in a US dialysis center setting. A study in Italy, focusing on management of secondary hyperparathyroidism in incident hemodialysis patients found little to no differences (including no cost differences) between 105 patients using oral calcitriol compared to 33 patients using intravenous paracalcitiol, but found that intravenous paracalcitol had slightly increased the percentage of patients at KDOQI targets at 6 months follow up (16). In our study, there were no significant differences in percentage of patients achieving KDOQI targets pre and post-conversion.…”

End-stage Renal Disease Costs for Patients New to Hemodialysis in Italy: The FARO-2 Study

“…As described elsewhere [29][30][31][32], the FARO study was a prospective multicenter survey that evaluated treatment practices in 28 dialysis centers in Italy from April 2006 to October 2007; during the study, data on secondary hyperparathyroidism (SHPT) management and alignment with Kidney Disease Outcomes Quality Initiative (KDOQI) target ranges from all patients receiving HD were recorded. The FARO-2 study [33][34][35] was designed to integrate the data of the Table 1. Sources for hospitalizations causes, reimbursement tariffs, and number of hospitalizations in Italy (2008) Causes of hospitalizations (as reported in the FARO-2 study)…”