Cinacalcet Treatment for Secondary Hyperparathyroidism in Dialysis Patients: An Observational Study in Routine Clinical Practice

Abstract

Background: Cinacalcet reduces intact parathyroid hormone (iPTH), Ca and P serum levels in patients with secondary hyperparathyroidism (SHPT). Methods: This Spanish, multicenter, observational, retrospective study collected data from SHPT dialysis patients 12 weeks before and up to 72 weeks after starting cinacalcet in clinical practice. Results: Data from 428 patients with uncontrolled SHPT despite receiving standard of care (29% with baseline iPTH 501–800 pg/ml; 51% with >800 pg/ml) were collected. Percentages of patients within National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets at baseline and 72 weeks were: iPTH, 0 versus 32.5% (p < 0.05); Ca, 40.1 versus 50% (p < 0.05); P, 47.7 versus 53.8% (p = 0.162). Vitamin D sterol use decreased from 53.3% at baseline to 36.7% at 72 weeks (p < 0.05). The mean ± SD cinacalcet dose at 72 weeks was 44.0 ± 25.8, 51.7 ± 31.3 and 57.1 ± 37.0 mg for patients with baseline iPTH 301–500, 501–800 or >800 pg/ml, respectively. The main adverse reactions were nausea (5.4%), dyspepsia (5.1%) and vomiting (3.7%). Conclusions: The introduction of cinacalcet improved the routine clinical management of SHPT in a large cohort of Spanish dialysis patients. Cinacalcet is effective and well tolerated regardless of disease severity, and maintains its efficacy over 72 weeks.

Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis

“…Success was low for patients with CKD 3 and CKD 4 and high only for patients with CKD 5. Low rates of achieving the goals were also observed in other non-dialysis trials [26], while higher compliance was observed in hemodialysis patients [14],[17–25]. Difficulties in clinical management or patient adherence to treatment could partially explain this low compliance [26].…”

“…However, in this study, 71% of patients with baseline PTH values > 300 pg/ml achieved at least a 30% reduction in their PTH value at 12 months, with a mean reduction of 42%. Nevertheless, the influence of PTH baseline values on the efficacy of cinacalcet is controversial in hemodialysis studies [14],[16–25]. In clinical practice trials in non-dialysis patients, higher baseline PTH values correlate to greater reduction, although no linear relation is observed [10–13].…”

“…Consequently, it seems that cinacalcet has an important intrinsic effect on reducing PTH values. Moreover, cinacalcet treatment reduces doses of vitamin D and analogues used in some studies [19],[21],[25]. …”

“…In hemodialysis patients, the efficacy of cinacalcet was comparable to that in non-dialysis patients, although with higher cinacalcet doses and higher baseline PTH values [14],[17–25]. However, the electrolyte profile is different.…”

Clinical and Practical Use of Calcimimetics in Dialysis Patients With Secondary Hyperparathyroidism

“…The combined results of RCTs and phase 4 studies confirmed these results (11,13,21,(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)) (Table1), among other benefits, including a substantial reduction of the elevated bone formation rate/tissue area, generally improving bone disease (57,58). Importantly, two recent prospective RCTs evaluated both the efficacy of cinacalcet in preventing the progression of CV calcifications (ADVANCE) (11), and its effect on clinical outcomes, including all-cause mortality and CV events (EVOLVE) (13).…”