Dataset Information

Serum phosphorus reduction in dialysis patients treated with cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone reduction.

ABSTRACT:

Background

The calcimimetic cinacalcet lowers parathyroid hormone (PTH), calcium (Ca) and phosphorus (P) in dialysis patients with secondary hyperparathyroidism (SHPT). We explored serum P changes in dialysis patients treated with cinacalcet, while controlling for vitamin D sterol and phosphate binder (PB) changes, based on data from the pan-European observational study ECHO.

Methods

Patients were categorized by serum P change (decreased/unchanged/increased) at 12 months after starting cinacalcet and subcategorized by vitamin D sterol and PB dose changes (decreased/unchanged/increased). The impact of PTH, Ca and P, and vitamin D sterol, PB and cinacalcet doses (absolute values and/or change) was evaluated. Predictors of P change were explored using univariate and multivariate general linear models (GLM) and logistic regression analysis.

Results

At Month 12, 661 (41%) of 1607 patients had decreased, 61 (4%) unchanged and 400 (25%) increased serum P, while 485 patients had missing data. In 45% of the patients with serum P reduction, vitamin D was either increased or unchanged and P binders decreased or unchanged. PTH was a key predictor of serum P reduction, with an estimated 3% decrease in P per 10% reduction in PTH. Changes in vitamin D sterol and PB doses were not generally significant factors in GLM and regression analyses.

Conclusions

The serum P reduction observed in a significant proportion of dialysis patients after adding cinacalcet to an existing therapeutic regimen for SHPT appears to result mainly from PTH reduction, rather than from changes in vitamin D sterol or PB doses. Financial support for the ECHO study was provided by Amgen.

SUBMITTER: Zitt E

PROVIDER: S-EPMC3665312 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Publications

Serum phosphorus reduction in dialysis patients treated with cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone reduction.

Zitt Emanuel E Fouque Denis D Jacobson Stefan H SH Malberti Fabio F Ryba Miroslav M Ureña Pablo P Rix Marianne M Dehmel Bastian B Manamley Nick N Vervloet Marc M

Clinical kidney journal 20130411 3

<h4>Background</h4>The calcimimetic cinacalcet lowers parathyroid hormone (PTH), calcium (Ca) and phosphorus (P) in dialysis patients with secondary hyperparathyroidism (SHPT). We explored serum P changes in dialysis patients treated with cinacalcet, while controlling for vitamin D sterol and phosphate binder (PB) changes, based on data from the pan-European observational study ECHO.<h4>Methods</h4>Patients were categorized by serum P change (decreased/unchanged/increased) at 12 months after sta ...[more]

PMID: 23717787

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Project description:BackgroundElevated serum phosphorus (P) levels have been linked to increased morbidity and mortality in dialysis patients with secondary hyperparathyroidism (SHPT) but may be difficult to control if parathyroid hormone (PTH) is persistently elevated. We conducted a post hoc analysis of data from an earlier interventional study (OPTIMA) to explore the relationship between PTH control and serum P.MethodsThe OPTIMA study randomized dialysis patients with intact PTH (iPTH) 300-799 pg/mL to receive conventional care alone (vitamin D and/or phosphate binders [PB]; n=184) or a cinacalcet-based regimen (n=368). For patients randomized to conventional care, investigators were allowed flexibility in using a non-cinacalcet regimen (with no specific criteria for vitamin D analogue dosage) to attain KDOQI™ targets for iPTH, P, Ca and Ca x P. For those assigned to the cinacalcet-based regimen, dosages of cinacalcet, vitamin D sterols, and PB were optimized over the first 16 weeks of the study, using a predefined treatment algorithm. The present analysis examined achievement of serum P targets (≤ 4.5 and ≤ 5.5 mg/dL) in relation to achievement of iPTH ≤ 300 pg/mL during the efficacy assessment phase (EAP; weeks 17-23).ResultsPatients who achieved iPTH ≤ 300 pg/mL (or a reduction of ≥ 30% from baseline) were more likely to achieve serum P targets than those who did not, regardless of treatment group. Of those who did achieve iPTH ≤ 300 pg/mL, 43% achieved P ≤ 4.5 mg/dL and 70% achieved P ≤ 5.5 mg/dL, versus 21% and 46% of those who did not achieve iPTH ≤ 300 pg/mL. Doses of PB tended to be higher in patients not achieving serum P targets. Patients receiving cinacalcet were more likely to achieve iPTH ≤ 300 pg/mL than those receiving conventional care (73% vs 23% of patients). Logistic regression analysis identified lower baseline P, no PB use at baseline and cinacalcet treatment to be predictors of achieving P ≤ 4.5 mg/dL during EAP in patients above this threshold at baseline.ConclusionsThis post hoc analysis found that control of serum P in dialysis patients was better when serum PTH levels were lowered effectively, regardless of treatment received.Trial registrationClinicaltrials.gov identifier NCT00110890.

Project description:BackgroundTotal parathyroidectomy (PTx) is often performed to treat secondary hyperparathyroidism (SHPT). Successful PTx is essential to prevent recurrent and persistent SHPT because remnant parathyroid glands (PTGs) in the neck can be stimulated and may secrete excessive parathyroid hormone (PTH) in end-stage renal disease. However, to date, few studies have investigated factors contributing to successful PTx before the completion of surgery.Materials and methodsBetween August 2010 and February 2020, 344 patients underwent total PTx, transcervical thymectomy, and forearm autograft for SHPT at our institute. Factors contributing to successful PTx before the completion of surgery were investigated. Preoperative imaging diagnoses, including computed tomography, ultrasonography, technetium-99m methoxyisobutylisonitrile (99mTc-MIBI) scintigraphy, intraoperative intact PTH (IOIPTH) monitoring, and frozen section histologic diagnosis, were performed. Successful PTx was defined as intact PTH level < 60 pg/mL on postoperative day 1. A sufficient decrease in IOIPTH level was defined as > 70% decrease in intact PTH levels measured 10 min after total PTx and transcervical thymectomy compared to intact PTH levels measured before skin incision. Logistic regression analysis was conducted to investigate factors contributing to PTx success.ResultsUnivariate analysis showed that the number of all PTGs identified preoperatively by imaging modalities and the specimens submitted for frozen section diagnosis, which surgeon presumed to be PTGs, were not significant factors contributing to successful PTx. However, multivariate analysis revealed that the number of PTGs identified by frozen section diagnosis (P < 0.001, odds ratio [OR] 4.356, 95% confidence interval [CI] 2.499-7.592) and sufficient decrease in IOIPTH levels (P = 0.001, OR 7.847, 95% CI 2.443-25.204) significantly contributed to successful PTx.ConclusionSufficient intact PTH level decrease observed on IOIPTH monitoring and the number of PTGs identified by frozen section diagnosis contributed to successful PTx for SHPT. IOIPTH monitoring and frozen section diagnosis are essential for achieving successful PTx for SHPT.

Dataset Information

Serum phosphorus reduction in dialysis patients treated with cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone reduction.

Background

Methods

Results

Conclusions

Publications

Serum phosphorus reduction in dialysis patients treated with cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone reduction.

Similar Datasets

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