Cinacalcet's effect on the pharmacokinetics of tacrolimus, cyclosporine and mycophenolate in renal transplant recipients

Falck, Pål; Vethe, Nils Tore; Åsberg, Anders; Midtvedt, Karsten; Bergan, Stein; Reubsaet, Léon; Holdaas, Hallvard

doi:10.1093/ndt/gfm632

Cited by 44 publications

(25 citation statements)

References 35 publications

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“…In addition, it supports studies that have shown that cinacalcet has no clinically relevant interaction with standard immunosuppressive drugs (53). The most frequently reported treatmentemergent AE in the cinacalcet group was diarrhea, similar to what has been reported in other CKD cohorts (7,9,21,54).…”

Section: Evenepoel Et Alsupporting

confidence: 84%

A Randomized Study Evaluating Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients With Persistent Hyperparathyroidism

Evenepoel

Cooper

Holdaas

et al. 2014

American Journal of Transplantation

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Persistent hyperparathyroidism (HPT) after kidney transplantation (KTx) is associated with hypercalcemia, hypophosphatemia and abnormally high levels of parathyroid hormone (PTH). In this randomized trial, cinacalcet was compared to placebo for the treatment of hypercalcemia in adult patients with persistent HPT after KTx. Subjects were randomized 1:1 to cinacalcet or placebo with randomization stratified by baseline corrected total serum calcium levels ( 11.2 mg/dL [2.80 mmol/L] or >11.2 mg/dL [2.80 mmol/L]). The primary end point was achievement of a mean corrected total serum calcium value <10.2 mg/dL (2.55 mmol/L) during the efficacy period. The two key secondary end points were percent change in bone mineral density (BMD) at the femoral neck and absolute change in phosphorus; 78.9% cinacalcetversus 3.5% placebo-treated subjects achieved the primary end point with a difference of 75.4% (95% confidence interval [CI]: 63.8, 87.1), p < 0.001. There was no statistical difference in the percent change in BMD at the femoral neck between cinacalcet and placebo groups, p ¼ 0.266. The difference in the change in phosphorus between the two arms was 0.45 mg/dL (95% CI: 0.26, 0.64), p < 0.001 (nominal). No new safety signals were detected. In conclusion, hypercalcemia and hypophosphatemia were effectively corrected after treatment with cinacalcet in patients with persistent HPT after KTx.

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Section: Evenepoel Et Alsupporting

confidence: 84%

A Randomized Study Evaluating Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients With Persistent Hyperparathyroidism

Evenepoel

Cooper

Holdaas

et al. 2014

American Journal of Transplantation

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“…A recent study of 9 patients reported a favorable effect of cinacalcet on BMD [50] . Cinacalcet was shown to have moderate effect on tacrolimus pharmacokinetics, but not on cyclosporine or mycophenolic acid [51] .…”

Section: Calcimimeticsmentioning

confidence: 92%

Metabolic bone diseases in kidney transplant recipients

Zhang

Chouhan²

2012

WJN

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Metabolic bone disease after kidney transplantation has a complex pathophysiology and heterogeneous histology. Pre-existing renal osteodystrophy may not resolve completely, but continue or evolve into a different osteodystrophy. Rapid bone loss immediately after transplant can persist, at a lower rate, for years to come. These greatly increase the risk of bone fracture and vertebral collapse. Each patient may have multiple risk factors of bone loss, such as steroids usage, hypogonadism, persistent hyperparathyroidism (HPT), poor allograft function, metabolic acidosis, hypophosphatemia, vitamin D deficiency, aging, immobility and chronic disease. Clinical management requires a comprehensive approach to address the underlying and ongoing disease processes. Successful prevention of bone loss has been shown with vitamin D, bisphosphonates, calcitonin as well as treatment of hypogonadism and HPT. Novel approach to restore the normal bone remodeling and improve the bone quality may be needed in order to effectively decrease bone fracture rate in kidney transplant recipients.

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“…Although large studies from dialysis patients demonstrate its safety, there is limited data in transplant patients. Cinacalcet was found to have moderate effect on tacrolimus pharmacokinetics, but not on cyclosporine or mycophenolate in renal transplant recipients (Falck et al, 2008). Thus, cinacalcet is not officially approved for usage in transplant patients yet.…”

Section: Calcimimeticsmentioning

confidence: 99%