Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era

Abstract

Summary Background and objectives Prescription patterns for hemodialysis patients with secondary hyperparathyroidism have varied widely since market introduction of cinacalcet. This study examined associations between prescription patterns and subsequent laboratory values. Design, setting, participants, & measurements Using a Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients subcohort, 1716 prevalent hemodialysis patients (4048 sets for repeated measures between January 2008 and July 2009) with an intact parathyroid hormone (iPTH) level >180 pg/ml who used intravenous vitamin D receptor activator (VDRA) without cinacalcet were selected. Prescription patterns were defined based on cinacalcet administration (starting or not) and VDRA dosage change (decreased [<−25%], stable [−25% to 25%], or increased [>25%]). Proportion differences (PDs) were determined for decreasing iPTH levels by at least one category (<180, 180–299, 300–499, and ≥500 pg/ml) and for achieving target phosphorus (3.5–6.0 mg/dl) and calcium (8.4–10.0 mg/dl) levels, adjusting for potential confounders. Results The starting cinacalcet and increased VDRA patterns were associated with decreasing iPTH levels (PD, 0.25 and 0.13; 95% confidence intervals [95% CIs], 0.19–0.31 and 0.09–0.17, respectively); combination use had an additive association (PD, 0.34; 95% CI, 0.20–0.42). The starting cinacalcet and decreased VDRA combination was associated with simultaneously achieving target phosphorus (PD, 0.12; 95% CI: 0.04–0.20) and calcium (PD, 0.09; 95% CI, 0.01–0.17) levels. Conclusions Certain combinations of cinacalcet and VDRA were associated with decreasing iPTH and achieving targets for phosphorus and calcium. Combinations may prove advantageous versus VDRA alone in managing secondary hyperparathyroidism.

Recent Changes in Therapeutic Approaches and Association with Outcomes among Patients with Secondary Hyperparathyroidism on Chronic Hemodialysis

“…The rise in cinacalcet and intravenous vitamin D analogs prescriptions is consistent with published region-specific data (32,33). Given the recent results of the Evaluation of Cinacalcet Hydrochloride Therapy to Lower CardioVascular Events Trial (34), in which cinacalcet treatment produced only an ambiguous and at most, modest effect on clinical outcomes, it will be interesting to continue to monitor potential changes in SHPT treatments.…”

Diameter of Parathyroid Glands Measured by Computed Tomography as a Predictive Indicator for Response to Cinacalcet in Dialysis Patients with Secondary Hyperparathyroidism

“…A recent subcohort study suggested that a combination of 'starting cinacalcet' and 'increased VDRA dose' was associated with better achievement of target iPTH levels than other treatments in cinacalcet-naïve patients [22]. Fukuma et al [23] hypothesized that differences in the mechanisms of action between VDRA and cinacalcet may provide an additive clinical benefit in the management of SPHT.…”

Pharmacological Management of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

“…Vitamin D is often used to counteract hypocalcaemia related to cinacalcet. Thus, the combination use of native vitamin D or its analogs with cinacalcet allows calcium, phosphate and PTH target levels to be achieved simultaneously and greater PTH reduction has been observed using this combination therapy compared to either agent alone (120,121). The OPTIMA study was an open label study which used an algorithm-based adjustment of VDRAs during the dose titration of cinacalcet in patients with moderate to severe SHPT (iPTH 300 -800 pg/ml).…”