Implementation of 'K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease' after the introduction of cinacalcet in a population of patients on chronic haemodialysis

Arenas, María Dolores; Álvarez-Ude, F; Gil, María Teresa Nevado; Moledous, A; Malek, T; Nuñez, Carlos M.; Devesa, R Corcuera Romero de la; Carretón, Maria Antonia; Soriano, Antonio

doi:10.1093/ndt/gfl840

Cited by 49 publications

(55 citation statements)

References 11 publications

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“…Prescription patterns for hemodialysis patients with secondary hyperparathyroidism have begun to vary widely since cinacalcet introduction (1)(2)(3), and the effects of these patterns on laboratory values (1-9) and clinical outcomes (10,11) have attracted attention. Before cinacalcet introduction, the only treatment option available for elevated parathyroid hormone (PTH) levels was vitamin D receptor activator (VDRA) (12).…”

Section: Introductionmentioning

confidence: 99%

Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era

Fukagawa

Fukuma

Ônishi³

et al. 2012

Clinical Journal of the American Society of Nephrology

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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.

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Section: Introductionmentioning

confidence: 99%

Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era

Fukagawa

Fukuma

Ônishi³

et al. 2012

Clinical Journal of the American Society of Nephrology

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“…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).…”

Section: Cinacalcet Use In Patients With Ckd Treated By Dialysismentioning

confidence: 55%

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

Bover

Ureña

Ruiz-García

et al. 2016

Clinical Journal of the American Society of Nephrology

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CKD and CKD-related mineral and bone disorders (CKD-MBDs) are associated with high cardiovascular and mortality risks. In randomized clinical trials (RCTs), no single drug intervention has been shown to reduce the high mortality risk in dialysis patients, but several robust secondary analyses point toward important potential beneficial effects of controlling CKD-MBD-related factors and secondary hyperparathyroidism. The advent of cinacalcet, which has a unique mode of action at the calcium-sensing receptor, represented an important step forward in controlling CKD-MBD. In addition, new RCTs have conclusively shown that cinacalcet improves achievement of target levels for all of the metabolic abnormalities associated with CKD-MBD and may also attenuate the progression of vascular and valvular calcifications in dialysis patients. However, a final conclusion on the effect of cinacalcet on hard outcomes remains elusive. Tolerance of cinacalcet is limited by frequent secondary side effects such as nausea, vomiting, hypocalcemia and oversuppression of parathyroid hormone, which may cause some management difficulties, especially for those lacking experience with the drug. Against this background, this review aims to summarize the results of studies on cinacalcet, up to and including the publication of the recent ADVANCE and EVOLVE RCTs, as well as recent post hoc analyses, and to offer practical guidance on how to improve the clinical management of the most frequent adverse events associated with cinacalcet, based on both currently available information and personal experience. In addition, attention is drawn to less common secondary effects of cinacalcet treatment and advisable precautions.

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“…29 The consistent achievement of KDOQI goals for bone and mineral metabolism has been difficult with standard therapy, with a large proportion of patients exhibiting persistent and refractory SHPT. [30][31][32][33] Not surprisingly, only about 6.6% and 10.9% of dialysis patients simultaneously met KDOQI targets for PTH, phosphorus, calcium, and calcium-phosphorus product levels in 2003 and 2004, respectively. 32 Presumably, this is related to the fact that attempts to suppress serum PTH with increasing doses of active vitamin D analogues are limited by the development of hypercalcemia and worsening hyperphosphatemia.…”

Section: Safety Profilementioning

confidence: 99%

“…32 Presumably, this is related to the fact that attempts to suppress serum PTH with increasing doses of active vitamin D analogues are limited by the development of hypercalcemia and worsening hyperphosphatemia. 33 The likelihood of developing hypercalcemia with active Vitamin D analogues is further increased by the concomitant use of calcium-containing phosphate binders. In contrast, cinacalcet while suppressing PTH levels simultaneously reduces serum calcium and phosphorus levels thereby adequately controlling not only PTH but also calcium, phosphorus, and calcium-phosphorus product and this effect may be sustained for up to 3 years.…”

Section: Safety Profilementioning

confidence: 99%

“…In contrast, cinacalcet while suppressing PTH levels simultaneously reduces serum calcium and phosphorus levels thereby adequately controlling not only PTH but also calcium, phosphorus, and calcium-phosphorus product and this effect may be sustained for up to 3 years. 12,15,19,[34][35][36] The calciumand phosphorus-lowering effect of cinacalcet enables the addition or increment of vitamin D therapy to further facilitate PTH suppression.…”

Section: Safety Profilementioning

confidence: 99%

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Review of cinacalcet hydrochloride in the management of secondary hyperparathyroidism

Yousaf

Charytan

2013

Renal Failure

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Cinacalcet is the first Food and Drug Administration-approved calcimimetic for the treatment of secondary hyperparathyroidism in dialysis patients. It is effective in improving control of parathyroid hormone, serum calcium, phosphorus, and calcium-phosphorus product. The calcium-lowering effect of cinacalcet overcomes the limitations of standard therapy associated hypercalcemia. There is evidence to suggest that cinacalcet has important clinical implications, which extend beyond its relevance in the treatment of secondary hyperparathyroidism. This review summarizes the evidence regarding the role of cinacalcet in the treatment of secondary hyperparathyroidism, disrupted bone mineral metabolism, cardiovascular disease, and mortality. In addition, the cost implications of cinacalcet are briefly explored.

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Implementation of 'K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease' after the introduction of cinacalcet in a population of patients on chronic haemodialysis

Abstract: In summary, the combination of cinacalcet and low doses of vitamin D improved significantly the control of PTH and Ca x P in patients with severe secondary hyperparathyroidism on chronic haemodialysis, without adverse effects and with lower doses of phosphate binders.

Cited by 49 publications

References 11 publications

Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era

Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era

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

Review of cinacalcet hydrochloride in the management of secondary hyperparathyroidism

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