Dynamics of cinacalcet use and biochemical control in hemodialysis patients: a retrospective New-user cohort design

Reams, B. Diane; Dluzniewski, Paul; P., Thy; Yue, Susan; Bradbury, Brian D.; Kshirsagar, Abhijit V.; Brookhart, M. Alan

doi:10.1186/s12882-015-0174-6

Cited by 15 publications

(17 citation statements)

References 24 publications

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“…Vitamin D can also lead to increased levels of serum calcium and serum phosphate The major limitations of cinacalcet use include GI effects, hypocalcemia, 18,39,52 and high discontinuation rates. [62][63][64][65] The most common adverse events for etelcalcetide include GI effects, diarrhea, and asymptomatic or symptomatic hypocalcemia. 66…”

Section: Beto Et Almentioning

confidence: 99%

“…and diet are self-administered and, thus, more challenging to accurately track. With regard to the calcimimetics, a number of studies have shown a high rate of discontinuation with cinacalcet, [62][63][64][65] In a 2010 study, 90 50% of nurses, 42% of dietitians, and 36% of social workers reported that they were ''tired'' or ''extremely tired'' of having to manage medication adherence in hemodialysis patients, as they were spending 13.8 hours each week addressing issues related to patient adherence to medications. Although strategies can be used to address adherence issues (high pill burden, forgetfulness, and frequent changes in medication schedule and dose), 91 nonadherence often leads to failure to achieve clinical targets for PTH, calcium, and phosphate.…”

Section: Beto Et Almentioning

confidence: 99%

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Overview of the 2017 KDIGO CKD-MBD Update: Practice Implications for Adult Hemodialysis Patients

Beto

Bhatt

Gerbeling³

et al. 2019

Journal of Renal Nutrition

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Renal dietitians play a pivotal role in the ongoing management of chronic kidney disease in patients on hemodialysis. Awareness of changes to clinical practice guidelines that may impact laboratory parameters associated with chronic kidney disease-mineral and bone disorder is important for optimal patient care. In this article, the Kidney Disease: Improving Global Outcomes 2017 Clinical Practice Guideline Update recommendations related to the treatment of secondary hyperparathyroidism in adults on hemodialysis are reviewed and treatment implications for renal dietitians discussed. Specific attention is given to the integration of updated recommendations such as the use of calcimimetics as part of a combination approach to the existing treatment paradigm. Renal dietitians can directly apply the updated clinical recommendations in the evaluation of diet composition; food additives; medication adherence challenges with phosphate binder type and use and serial monitoring of phosphorus, calcium, and parathyroid hormone levels to inform clinical decisions on treatment options for patients.

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Section: Beto Et Almentioning

confidence: 99%

Section: Beto Et Almentioning

confidence: 99%

Overview of the 2017 KDIGO CKD-MBD Update: Practice Implications for Adult Hemodialysis Patients

Beto

Bhatt

Gerbeling³

et al. 2019

Journal of Renal Nutrition

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“…Therefore, there was a statistically signif-morbidity and mortality in patients with secondary hyperparathyroidism due to dialysis. The available options for treatment of bone mineral disorders do not always provide adequate control of PTH, calcium and phosphorus levels, and are often associated with mismatch and high incidence of discontinuation (2)(3)(4)(5).…”

Section: Resultsmentioning

confidence: 99%

Tracing and comparing serum, specific, bone biomarkers in patients with secondary hyperparathyroidism

Staykova

Bocheva

2018

Scripta Scientifica Medica

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Bone and mineral disorders (BMDs) in chronic kidney disease (CKD) are increasingly being studied, and prophylaxis and treatment are conducted, but they still remain one of the most severe systemic illnesses in patients with CKD. In patients with end-stage CKD and secondary hyperparathyroidism, accompanying metabolic disorders of calcium and phosphorus homeostasis may lead to pathological changes in bone and blood vessels, which increase the risk of bone fractures and cardiovascular (CV) events. High levels of parathyroid hormone (PTH), calcium and phosphorus are associated with increased morbidity and mortality in dialysis patients. Dialysis treatment is a renal replacement method that continues the life of patients with CKD, temporarily improving existing bone pathology, but it more often accelerates its progression. Therefore, the symptoms, developmental and complications of BMD-CKD are demonstrated and manifested in patients with extracorporeal treatment. Treatment of BMD requires constant monitoring of CaP exchange, PTH, serum of Vitamin D levels and the protein bone markers-osteocalcin, bone alkaline phosphatase. Despite the systemic use of active metabolites of vitamin D, phosphate binders and calcimimetics, in many patients with secondary hyperparathyroidsm, inadequate biochemical control has been observed. In the Dialysis Clinic at St. Marina University Hospital, Varna, two groups of patients on hemodialysis (HD) and with CKD-2/3 stage with secondary hyperparathyroidism, were followed and had their serum biomarker levels compared-PTH, bone alkaline phosphatase (BAP), osteocalcin, and vitamin D. The results showed statistically significant differences between the two groups in the investigated serum levels of the indicators.

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“…We modelled discontinuation with a parametric Weibull function (see electronic supplementary material). For the base case, we used the United States (US) real world data [ 21 ]. To test the sensitivity of the model to persistence assumptions, we applied EVOLVE trial persistence as an upper bound, and the lowest observed real-world persistence in Europe as a lower bound (one-year persistence: EVOLVE 73%, US 27%, France 27%, Germany 22%, Italy 16%).…”

Section: Methodsmentioning

confidence: 99%

A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet

Stollenwerk

Iannazzo²,

Akehurst

et al. 2018

PharmacoEconomics

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Introduction and objective:Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogs; PB/VD) was evaluated in three phase 3 studies, including two placebocontrolled trials and a head-to-head study versus the oral calcimimetic cinacalcet. The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared to cinacalcet. Methods:We developed a life time Markov model including potential treatment effects on mortality, cardiovascular events, fractures, and subjects' persistence. Long term efficacy of etelcalcetide was extrapolated from the reduction in parathyroid hormone (PTH) in the phase 3 trials and the available data for outcomes study in cinacalcet (EVOLVE trial).Etelcalcetide was compared to cinacalcet, both in addition to PB/VD. We applied unit costs averaged from five European countries and a range of potential pricing options assuming parity price to weekly use of cinacalcet and varying it 15% or 30% higher. Results: Compared with cinacalcet, the incremental cost-effectiveness ratio of etelcalcetide was €1.355 per QALY, €24,521 per QALY and €47,687 per QALY for the three prices explored. The results were robust across the probabilistic and deterministic sensitivity analyses. Conclusions: Our modelling approach enables cost utility assessment of the novel therapy for SHPT based on the observed and extrapolated data. This model can be used for local adaptations in the context of reimbursement assessment. Page 4 KEY POINTS FOR DECISION MAKERS  While no hard outcomes data are available for etelcalcetide, its superior efficacy in reducing parathyroid hormone, compared to the oral calcimimetic cinacalcet, enables extrapolation to improved rate of survival, cardiovascular events, fractures and parathyroidectomy. We provide a model which can be used to assess the cost-effectiveness of etelcalcetide compared to cinacalcet, both in addition to phosphate binders and vitamin D analogs.

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Dynamics of cinacalcet use and biochemical control in hemodialysis patients: a retrospective New-user cohort design

Cited by 15 publications

References 24 publications

Overview of the 2017 KDIGO CKD-MBD Update: Practice Implications for Adult Hemodialysis Patients

Overview of the 2017 KDIGO CKD-MBD Update: Practice Implications for Adult Hemodialysis Patients

Tracing and comparing serum, specific, bone biomarkers in patients with secondary hyperparathyroidism

A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet

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