Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study

Rottembourg, Jacques; Ureña-Torres, Pablo; Toledano, Daniel; Gueutin, Victor; Hamani, Abdelaziz; Coldefy, Olivier; Hebibi, Hedia; Guincestre, Thomas; Émery, C.

doi:10.1093/ckj/sfz021

Cited by 19 publications

(20 citation statements)

References 30 publications

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“…While direct comparisons of etelcalcetide to cinacalcet or no calcimimetic therapy were beyond the scope of the current manuscript, they are investigated in a recent systematic review and meta-analysis by Palmer et al [38] who found that etelcalcetide was more effective at lowering PTH than cinacalcet, but with an increased risk of hypocalcemia. A large observational study of cinacalcet initiators in France [39] showed that the proportion of patients with PTH out of target range (>9x upper limit) after 12 months was 41%, compared to 26% with PTH >600 pg/mL after 12 months in our study of etelcalcetide initiators. In both studies, however, the likelihood of PTH in-target after 12 months was highly dependent on baseline SHPT severity, suggesting the potential benefit of treating SHPT at earlier stages.…”

Section: Discussioncontrasting

confidence: 59%

Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease–Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients

Karaboyas

Muenz

Fuller

et al. 2022

American Journal of Kidney Diseases

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Section: Discussioncontrasting

confidence: 59%

Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease–Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients

Karaboyas

Muenz

Fuller

et al. 2022

American Journal of Kidney Diseases

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“…Current guidelines recommend active vitamin D prescription and calcimimetics in order to maintain PTH levels in the recommended ranges in HD patients. In real life, observational studies showed that calcimimetic prescription is less than expected, and that treatment can be challenging to achieve and to maintain in the long term, partly due to gastrointestinal intolerance [ 43 ]. Moreover, reimbursement criteria do not necessarily match with guidelines, and local committees (such as in Sweden and Australia) may not recommend calcimimetic use except in patients at high risk, due to the inconclusive results of the EVOLVE (EValuation Of Cinacalcet Hydrochloride Therapy to Lower CardioVascular Events) trial [ 44 ].…”

Section: Discussionmentioning

confidence: 99%

The risk of medically uncontrolled secondary hyperparathyroidism depends on parathyroid hormone levels at haemodialysis initiation

Tabibzadeh

Karaboyas

Robinson

et al. 2020

Nephrology Dialysis Transplantation

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Background Optimal parathyroid hormone (PTH) control during non-dialysis chronic kidney disease (ND-CKD) might decrease the subsequent risk of parathyroid hyperplasia and uncontrolled secondary hyperparathyroidism (SHPT) on dialysis. However, the evidence for recommending PTH targets and therapeutic strategies is weak for ND-CKD. We evaluated the patient characteristics, treatment patterns and PTH control over the first year of haemodialysis (HD) by PTH prior to HD initiation. Methods We studied 5683 incident HD patients from 21 countries in Dialysis Outcomes and Practice Patterns Study Phases 4–6 (2009–18). We stratified by PTH measured immediately prior to HD initiation and reported the monthly prescription prevalence of active vitamin D and calcimimetics over the first year of HD and risk of PTH >600 pg/mL after 9–12 months on HD. Results The 16% of patients with PTH >600 pg/mL prior to HD initiation were more likely to be prescribed active vitamin D and calcimimetics during the first year of HD. The prevalence of PTH >600 pg/mL 9–12 months after start of HD was greater for patients who initiated HD with PTH >600 (29%) versus 150–300 (7%) pg/mL (adjusted risk difference: 19%; 95% confidence interval : 15%, 23%). The patients with sustained PTH >600 pg/mL after 9–12 months on HD were younger, more likely to be black, and had higher serum phosphorus and estimated glomerular filtration rates at HD initiation. Conclusions Increased PTH before HD start predicted a higher PTH level 9–12 months later, despite greater use of active vitamin D and calcimimetics. More targeted PTH control during ND-CKD may influence outcomes during HD, raising the need for PTH target guidelines in these patients.

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“…спостереження цільовий рівень ПТГ був досягнутий лише у 10,4% пацієнтів. Це корелює з даними дослідження Jacques Rottembourg зі співавторами [12]. В цьому дослідженні проводилася ретроспективна оцінка показників мінерального обміну у гемодіалізних хворих з ВГПТ, які лікувалися цинакальцетом.…”

Section: Complete Censoredunclassified

Еffectiveness of long-term cinacalcet administration in hemodialysis patients with secondary hyperparathyroidism: A prospective, historically controlled study

Лобода

Shifris

Krasyuk

et al. 2021

Ukr. J. Nephrol. and Dial.

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Abstract. Our study aimed to determine the long-term effects of cinacalcet in hemodialysis patients with secondary hyperparathyroidism. Materials and methods. The study was conducted in 2 phases. At Phase 1, a retrospective analysis of data from 238 outpatient cards of patients treated with hemodialysis on the Kyiv City Center of Nephrology and Dialysis in 2015-2018 was conducted. According to the inclusion and exclusion criteria, data from 93 patients who made up the historical observation group were selected for further analysis In Phase 2, a prospective cohort study lasting 18 months was conducted. The study included 82 hemodialysis patients treated on the Kyiv City Center of Nephrology and Dialysis in the period from 2019 to 2021. These patients were the main observation group. Patients of the main group were prescribed cinacalcet for the correction of secondary hyperparathyroidism. The primary endpoint of the study was death from any cause, surrogates - deaths from cardiovascular events, fractures, parathyroidectomy. Results. At the end of the follow-up period, the target PTH level was in 48 (64.9%) of the 74 survived patients (main group). In another 22 (29.7%) patients the PTH level was ≥40% lower than the initial level. There were no significant changes in PTH levels in 4 (5.4%) patients. At the end of treatment, the level of PTH in the main group was 398 (385; 521.4) pg/ml (p <0.001). The dose of cinacalcet was 60 (30; 90) mg/day. At patients of the historical group in 18 months observation, the target PTH level was reached in 8 (10.4%) of the 77 survived patients, in 10 (12.9%) patients the PTH level decreased by more than 40% compared to baseline, and in 59 (76, 7%) of patients, there were no significant changes in PTH levels. At the end of treatment, the level of PTH in the historical group was 859.7 (568; 928.9) pg/ml (p> 0.05). 32 (23%) patients reported at least one adverse event (AE) associated with cinacalcet. The stated AEs in most cases were mild and did not require discontinuation of the drug. During the observation period in the historical group, the overall mortality rate was more than 1.7 times higher than in the main group, but this difference was not statistically significant (RR 1.76, 95% CI: 0.796 - 3.905). The cardiovascular mortality in the historical group was more than 2.4 times higher than in the main group, but this difference was not statistically significant (RR 2.47, 95% CI: 0.929 - 6.558). In the main group, 4 cases of fractures were recorded (4.9%). The frequency of fractures in the historical group was 2.4 times higher than in the main group, but this difference was not statistically significant (RR 2.425, 95% CI: 0.803 - 7.32). The difference in the frequency of parathyroidectomies was statistically significant in the historical group and was almost 3.3 times higher than in the main group (RR 3.306, 95% CI: 1.143 – 9.565). Conclusions. The obtained data showed the high efficiency of cinacalcet in the correction of high PTH levels, as well as a beneficial effect on important clinical consequences.

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Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study

Cited by 19 publications

References 30 publications

Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease–Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients

Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease–Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients

The risk of medically uncontrolled secondary hyperparathyroidism depends on parathyroid hormone levels at haemodialysis initiation

Еffectiveness of long-term cinacalcet administration in hemodialysis patients with secondary hyperparathyroidism: A prospective, historically controlled study

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