Cinacalcet for hemodialyzed patients with or without a high PTH level to control serum calcium and phosphorus: ECO (evaluation of cinacalcet HCl outcome) study

Yokoyama, Keitaro; Ohkido, Ichiro; Ishida, Mari; Hashimoto, Hiroyuki; Urae, Jun; Saito, Hiroshi; Kimura, Yasuo; Shimada, Hirokazu; Urashima, Mitsuyoshi; Hosoya, Tatsuo

doi:10.5414/cn107285

Cited by 10 publications

(6 citation statements)

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“…From pharmacodynamic point of view, although subset of patient with baseline iPTH ≥800 pg/mL showed extremely high variance in the chance to achieve target iPTH (≤250 pg/mL), when we conducted the subgroup analysis for the endpoint of ≥30% down‐regulation of iPTH, in either subset of patients with iPTH <800 or ≥800 pg/mL, Cinacalcet group showed statistically significant improvement of target achievement (≥30% down‐regulation of iPTH) compared to placebo group. It is consistent to the previous report that Cinacalcet also appears to be reserved for use in patients with more severe disease . Pablo et al also reported that 21% of patients with baseline iPTH above 800 pg/mL achieved iPTH target level set by K/DOQI guideline.…”

Section: Discussionsupporting

confidence: 91%

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Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis

Mei

Chen

Ding

et al. 2016

Hemodialysis International

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Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels.

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Section: Discussionsupporting

confidence: 91%

“…It is consistent to the previous report that Cinacalcet also appears to be reserved for use in patients with more severe disease. 22,23 Pablo et al 23 also reported that 21% of patients with baseline iPTH above 800 pg/mL achieved iPTH target level set by K/DOQI guideline.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis

Mei

Chen

Ding

et al. 2016

Hemodialysis International

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“…The addition of cinacalcet hydrochloride to this 9‐section chart is a change from the previous guideline. Although cinacalcet hydrochloride is mainly used to suppress PTH, it is included in the cases in which the PTH level is high (or low), because cinacalcet hydrochloride simultaneously lowers serum phosphorus/calcium levels , and PTH control and serum phosphorus/calcium control are closely linked. In other words, administering cinacalcet hydrochloride as a method to control the serum calcium or phosphorus level is advisable for patients with high serum PTH levels.…”

Section: Rationalementioning

confidence: 99%

Clinical Practice Guideline for the Management of Chronic Kidney Disease‐Mineral and Bone Disorder

et al. 2013

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“…The addition of cinacalcet hydrochloride to this nine-section chart is a change from the previous guideline. Although cinacalcet hydrochloride is mainly used to suppress PTH, it is included in the cases in which the PTH level is high (or low), because cinacalcet hydrochloride simultaneously lowers serum phosphorus/calcium levels, 24, 25 and PTH control and serum phosphorus/calcium control are closely linked. In other words, administering cinacalcet hydrochloride as a method to control the serum calcium or phosphorus level is advisable for patients with high serum PTH levels.…”

Section: Control Of Serum Phosphorus and Calciummentioning

confidence: 99%

A Japanese approach for CKD-MBD

Yokoyama

Taniguchi

Fukagawa

2013

Kidney International Supplements

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Disturbances in mineral and bone metabolism have a critical role in the pathogenesis of cardiovascular complications in patients with chronic kidney disease (CKD). The term ‘renal osteodystrophy' has recently been replaced by ‘CKD-mineral and bone disorder (CKD-MBD)', which includes abnormalities in bone and mineral metabolism and vascular calcification. The Japanese Society for Dialysis Therapy clinical practice guideline for the management of secondary hyperparathyroidism in chronic dialysis patients was originally published in Japanese in 2006, then in English in 2008. During the past 5 years, this first guideline has contributed to a considerably better understanding and control of secondary hyperparathyroidism in CKD patients by physicians, other medical professionals, and the patients themselves. However, since its publication several new therapeutic modalities have become available for Japanese dialysis patients, which added more evidence to this area. Thus, we revised the guideline to include several new policies, and the new guideline was published in Japanese in 2012. This article contains the new guideline text, and clinical significance of CKD-MBD in Japan.

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Cinacalcet for hemodialyzed patients with or without a high PTH level to control serum calcium and phosphorus: ECO (evaluation of cinacalcet HCl outcome) study

Cited by 10 publications

References 0 publications

Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis

Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis

Clinical Practice Guideline for the Management of Chronic Kidney Disease‐Mineral and Bone Disorder

A Japanese approach for CKD-MBD

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