Hyperparathyroidism In Hemodialysis Patients Research Articles

#2823 High doses and levels of cholecalciferol for secondary hyperparathyroidism in hemodialysis patients

Abstract Background and Aims Vitamin D is crucial for musculoskeletal and general health. Low levels are associated with an increased risk of death and morbidity, including cancer, cardiovascular, autoimmune diseases and infections. In hemodialysis (HD) patients vitamin D deficiency plays additionally an important role in the pathogenesis of Chronic Kidney Disease–Mineral And Bone Disorder (CKD-MBD), including the development of secondary hyperparathyroidism (SHP). Determination of 25(OH)D levels in CKD patients and the administration of cholecalciferol according to the guidelines for the general population is recommended. The literature data show that therapy even with high doses of cholecalciferol appear to be safe and sufficient to increase 25(OH)D level > 30 ng/ml in HD patients. However, the prevailing opinion is that PTH lowering with cholecalciferol in CKD is unproven and clinically insignificant. The aim of the study was to evaluate the efficacy (including PTH concentration) and safety of increasing vitamin D levels from the recommended 30 ng/mL to >75 ng/mL in HD patients treated with high doses of cholecalciferol. Method 22 HD patients (16 M, 6 F)), with an average age of 72.5 ± 13.03 years and 25(OH)D concentration 30–50 ng/mL were administered cholecalciferol at a therapeutic dose of 70,000 IU/week (20,000 IU + 20,000 IU + 30,000 IU, immediately after each dialysis session) to reach the target serum 25(OH)D level > 75 ng/mL, but not longer than for 24 weeks. The baseline data on calcium, phosphate, 1,84 PTH, 25(OH)D and 1,25(OH)2D serum levels were compared with the data when 25(OH)D > 75 ng/mL was achieved or when the highest 25(OH)D levels were noted. Results A significant decrease in 1,84 PTH levels was observed during the study (542.36 ± 420.87 vs 230.99 ± 386.22 pg/mL; p < 0.005). No significant effect on calcium (8.91 ± 0.57 vs 9.03 ± 0.63 mg/dL; p = 0.23) and phosphate (4.6 ± 1.06 vs 4.81 ± 1.06 mg/dL; p = 0.93) concentrations was shown. There was also significant increase in 25(OH)D and 1,25(OH)2D levels (35.52 ± 8.26 vs 79.83 ± 21.38 ng/mL; p < 0.005, and 13.38 ± 7.26 vs 25.56 ± 12.80 pg/mL; p < 0.005, respectively). In the range of 25(OH)D levels 30-50 ng/mL 25(OH)D correlated positively with 1,25(OH)2D levels, r = 0.305. When 25(OH)D levels exceeded 50 ng/mL, there was negative correlation with 1,25(OH)2D levels (r = –0 .177 for 25(OH)D 50-75 ng/mL, and r = –0.262 for 25(OH)D >75 ng/mL). Conclusion Our study showed that the administration of high therapeutic doses of cholecalciferol to achieve 25(OH)D levels >75 ng/mL was safe, without the risk of hypercalcemia and hyperphosphatemia. Raising of 25(OH)D levels to the upper limit of the laboratory norm resulted in significant decrease in PTH levels. Cholecalciferol may be useful in the treatment of SHP in HD patients, but higher 25(OH)D levels seem to be crucial.

Effect of paricalcitol on biochemical markers of secondary hyperparathyroidism in hemodialysis patients

Effect of paricalcitol on biochemical markers of secondary hyperparathyroidism in hemodialysis patients

Observation of the efficacy of parathyroidectomy for secondary hyperparathyroidism in hemodialysis patients: a retrospective study

PurposeParathyroidectomy (PTX) is commonly performed as a treatment for secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease (ESRD). We aimed to evaluate the efficacy of PTX in patients with SHPT who underwent hemodialysis.MethodsThis retrospective study analyzed the clinical treatment of 80 hemodialysis patients with SHPT who underwent either total PTX with forearm auto transplantation (TPTX + AT) or subtotal parathyroidectomy (SPTX). We compared the changes in biochemical indices before and after surgery as well as the attenuation of intact parathyroid hormone (iPTH) in the TPTX and SPTX groups. We also evaluated clinical symptoms and quality of life using the Visual Analog Scale (VAS) and the Short Form-36 Questionnaire (SF-36) before and at 3, 6, and 12 months after surgery.ResultsSerum iPTH and serum phosphorus levels decreased significantly after surgery in 80 patients with SHPT (P < 0.05). Within one month of surgery, there was a difference in iPTH levels between the TPTX + AT and SPTH groups, but there was no difference over time. Patients experienced significant improvement in their clinical symptoms of restless leg syndrome, skin itching, bone pain, and joint pain at 1 week post operation (P < 0.001). Quality of life significantly improved after surgery, as assessed by SF-36 scores (P < 0.05). Hypocalcemia was the most common postoperative complication, occurring in 35% of patients. Within the first 12 months post surgery, 5 patients had a recurrence.ConclusionPTX is effective in rapidly reducing iPTH levels, improving calcium and phosphorus metabolism disorders, and enhancing patients’ quality of life by safely and effectively relieving clinical symptoms.

Calcitriol Versus Calcitriol and Low Dose Cinacalcet for Treating Severe Secondary Hyperparathyroidism in Hemodialysis Patients: A Randomized Clinical Trial

Background: Secondary hyperparathyroidism is prevalent among hemodialysis patients associated with vascular and skeletal complications. Thus, treatment is required, specially before kidney transplantation. Objectives: This study aimed to compare the efficacy of calcitriol and cinacalcet versus standard-dose calcitriol in treating severe secondary hyperparathyroidism in hemodialysis patients. Methods: This randomized clinical trial was conducted on 70 hemodialysis patients with severe secondary hyperparathyroidism who were randomly allocated to two intervention groups. Group A received calcitriol 1mg PO every other night, and group B took calcitriol 1mg PO every other night and cinacalcet 30mg PO daily. The improvement of laboratory parameters was investigated 3 and 6 months after the intervention. Results: There was no significant difference between the two groups regarding age, sex, body mass index, and duration of dialysis (P &gt; 0.05). In group A, serum levels of calcium (P &lt; 0.001) and parathyroid hormone (PTH) (P &lt; 0.001) were significantly reduced compared to baseline. However, phosphorus (P = 0.175) and albumin (P = 0.143) serum levels showed no significant changes. In group B, calcium (P = 0.001), PTH (P &lt; 0.001), and serum phosphorus (P &lt; 0.001) levels were significantly decreased after the intervention. Nevertheless, serum albumin levels showed no significant changes from baseline (P = 0.061). Changes in serum phosphorus (P &lt; 0.001) and PTH levels (P &lt; 0.001) were significantly different between the groups. However, changes in serum calcium (P = 0.062) and albumin levels (P = 0.773) were not significantly different (Wilcoxon signed-rank test). Conclusions: The results of this study showed that treatment with cinacalcet and calcitriol was more effective than calcitriol alone without any side effects.

#4993 EFFECT OF ETELCALCETIDE TREATMENT ON ERYTHROPOIESIS-STIMULATING AGENTS (ESAS) REQUIREMENT IN HEMODIALYSIS PATIENTS: A SINGLE CENTER STUDY

Abstract Background and Aims Anemia is a common consequence of advanced chronic kidney disease (CKD). There are various causes of renal anemia like decreased production of and resistance to Erythropoietin, shortened survival of red blood cells and chronic blood loss. Secondary hyperparathyroidism is a potential cause of renal anemia in CKD patients due to direct effect on Erythropoietin synthesis, red cell survival and bone marrow fibrosis [1]. There are several reports of the beneficial effect of treatment of hyperparathyroidism on hemoglobin (Hb) levels. Etelcalcetide is a novel intravenous calcimimetic used for the treatment of secondary hyperparathyroidism in hemodialysis patients. However, there are very few reports of Etelcalcetide's effect on anemia management in hemodialysis patients. We aimed to study the effect of Etelcalcitide on ESAs requirement in our hemodialysis cohort. Method This is a retrospective study in Al Wakra Hospital hemodialysis unit conducted on patients with uncontrolled secondary hyperparathyroidism who needed to be started on Etelcalcetide. Mean Hb and mean ESAs dose were calculated for a period of 6 months before and 6 months after starting Etelcalcetide, while iPTH levels were measured at the beginning and 6 months after starting Etelcalcetide. Inclusion criteria: hemodialysis patients who are on Etelcalcetide for at least 6 months. Exclusion criteria: Patients’ age &amp;lt; 18 years, hemodialysis duration &amp;lt; 12 months and patients with acute blood loss. Results Out of 94 hemodialysis patients, 26 (27.6%) were on Etelcalcetide. 2 patients were excluded, one for acute hematuria and the other for erosive gastritis. 24 patients were included (13 females and 11 males). Mean age of the patients was 58.7 years. 15 patients were on Darbepoetin, 8 on Erythropoietin and 1 patient was switched from Darbepoetin to Erythropoietin due to poor response. There was no significant difference in mean Hb levels for all the patients before and after starting Etelcalcetide (10.6 g/dl and 10.8 g/dl, respectively). Out of 24 patients, 19 had reduction while 5 had increase in ESAs dose requirement. In total, the mean reduction of ESAs dose for all the patients was 17.3%. There was a mean of 33.4% reduction in ESAs requirement for the 19 patients while a mean of 44% increase in the requirement for the 5 patients. Mean iPTH for the cohort at the time of starting Etelcalcetide and 6 months after was 1036 pg/ml and 473 pg/ml respectively. The mean reduction of iPTH for those who had decreased ESAs requirement was 58% while it was 38.8% for those who had increased ESA requirement. Conclusion This study showed that control of severe secondary hyperparathyroidism with Etelcalcetide was associated with reduction in ESAs requirement in hemodialysis patients. The more the control of hyperparathyroidism, the more the reduction of ESAs requirement. These findings were observed also in a one case report [2]. We believe that our study has one of the largest number of patients to show such an observation, however larger controlled studies are needed to confirm these preliminary findings in the improvement of anemia after treatment of hyperparathyroidism by Etelcalcetide.

Severe calcific uremic arteriolopathy lessions and acute hypocalcemia after parathyroidectomy for secondary hyperparathyroidism in haemodialysis patients: Case series

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

The effect of paricalcitol and cinacalcet on parathyroid hormone in patients undergoing chronic hemodialysis and serum calcium and phosphorus oscillation

Chronic kidney disease (CKD) is one of the leading public health problems in the world, and according to research conducted on different races and in different parts of the world, approximately one in 10 adults has some form of kidney damage. In stage 3 CKD, the kidneys lose the ability to remove excess phosphorus that accumulates in the body, leading to hyperphosphatemia, which promotes an increase in parathyroid hormone (PTH), and the appearance of secondary hyperparathyroidism. It is associated with increased morbidity and mortality and negatively affects the quality of life of patients with chronic kidney disease. It is generally considered that parathyroid hormone is a systemic "toxin" in CKD and its increased secretion is a sign of progression of kidney disease. Homeostasis of calcium and phosphorus is maintained through a complex connection between bones, intestines, kidneys and parathyroid glands. A retrospective - prospective study will be conducted in the hemodialysis center of the Živinice Health Center. 49 patients suffering from secondary hyperparathyroidism will be included in the study. Patients are of both sexes, aged 18 to 85 years. As part of secondary hyperparathyroidism in hemodialysis patients, 75.5% of patients had PTH values below 1000 pg/ml, while 24.5% had PTH values above 1000 pg/ml. A decrease in serum Ca and P values was recorded in 32% of subjects who were treated with paricalcitol. A decrease in serum Ca and P values was recorded in 56% of cases. Observing the effect of paricalcitol and cinacalcet, it is observed that the greatest reduction in PTH values in patients who had PTH values higher than 1000pg/ml - treated with cinacalcet is 44%.

Evaluation of Cholecalciferol Efficacy in the Management of Secondary Hyperparathyroidism in Hemodialysis Patients

The deficiency of vitamin D is public among hemodialysis (HD) patients and is a key factor in the development of secondary hyperparathyroidism (SHPT). Secondary hyperparathyroidism is currently accomplished by lowering circulating phosphate levels with parathyroid hormone (PTH), vitamin D analogs, and oral binders. The current study aim was to assess the efficacy of cholecalciferol in the management of secondary hyperparathyroidism in hemodialysis patients with concomitant vitamin D deficiency/insufficiency. A total of 53 patients were taken with25 male and 28 female patients. After treating patients with cholecalciferol, serum PTH levels improved significantly, with mean pre-treatment levels of 486.99±191.10, which had decreased to a mean post-treatment level of 301.66±201.08. Serum Vitamin D levels also improved significantly, with mean pre-treatment levels of 10.86±4.98, which increased to a mean post-treatment level of 29.98±17.24. Patients treated with cholecalciferol had no significant change in phosphorous and calcium levels. Keywords: Parathyroid Hormone; Cholecalciferol; Vitamin D; Secondary Hyperparathyroidism; hemodialysis; Pakistan

Parathyroidectomy Versus Cinacalcet for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients

BackgroundSecondary hyperparathyroidism in patients with end stage renal disease on dialysis is associated with bone pain and fractures in addition to cardiovascular morbidity. Cinacalcet is the most commonly used drug to treat such patients, but it has never been compared to surgery. The goal of this study is to compare the long-term outcomes and survival between cinacalcet and parathyroidectomy in the treatment of secondary hyperparathyroidism in hemodialysis patients.MethodsAdult patients on hemodialysis who were treated with cinacalcet or parathyroidectomy in the United States Renal Data System were included. Patients treated with surgery (n = 2023) were compared using 1:1 propensity score matching ratio to a cohort of patients treated with cinacalcet. A Cox regression analysis was conducted to compare the overall mortality.ResultsThe propensity score matching successfully created two groups with similar demographics. Patients in the surgery group had a higher mean peak PTH level prior to therapy (2066.8 vs 1425.4, P < 0.001). No difference was observed in the development of new-onset coronary artery disease (7.7% vs 7.9%, P = 0.8) or cerebrovascular disease (7% vs 6.7%, P = 0.8). Surgical patients had a higher rate of pathologic fractures (27.8% vs 24.9%, P = 0.04). Survival analysis showed that patients undergoing surgery had a better 5-year survival (65.6% vs 57.8%) and were less likely to die within the study period (HR 0.77, 95% CI 0.7–0.85, P < 0.0001).ConclusionsPatients on dialysis undergoing parathyroidectomy for the treatment of secondary hyperparathyroidism have a better overall survival than those treated with cinacalcet.

A comparative study on the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients; a double-blinded randomized clinical trial

Introduction:Chronic kidney disease (CKD) has lots of complication like calcium and phosphate metabolism disorders, hyperparathyroidism, vitamin D deficiency and metabolic acidosis. Objectives: The aim of this study was to determine and compare the effect of calcitriol and cinacalcet on hyperparathyroidism in hemodialysis patients due to end-stage renal disease (ESRD). Patients and Methods: This study was a double-blinded randomized clinical trial, which was conducted on 60 hemodialysis patients in 2017-2018. The patients were randomly assigned to two groups of 30 patients, which one group was treated with cinacalcet and the other group was treated with calcitriol. During this study, phosphorus, calcium and iPTH were measured. Results: The results showed that in the group treated with cinacalcet, the amount of calcium [t(22)=0.294, P&gt;0.05] and the amount of phosphorus [t(22)=1.87, P&gt;0.05] did not change significantly while iPTH values before and after the study had statistically significant difference [t(22)=4.37, P&lt;0.05]. In group treated with calcitriol, the calcium, phosphorus and iPTH values did not change significantly (P&gt;0.05). Calcium changes in the cinacalcet group compared to the calcitriol group [t (47) =-1.14, P&gt;0.05] and also, the amount of phosphorus changes [t (47) =-1.022, P&gt;0.05] was not statistically significant. The iPTH changes were not statistically significant between the two groups however iPTH in the calcitriol group was higher than the cinacalcet group [t (47) =-1.13, P&gt;0.05]. Conclusion: In contrast to calcitriol, cinacalcet significantly reduced iPTH and did not significantly change calcium and phosphorus levels. Trial Registration: The trial was registered by Iranian Registry of Clinical Trials (IRCT) (identifier: IRCT20190702044076N1; https://en.irct.ir/trial/40547, Ethical code# IR.SKUMS.REC.1397.026).

Circulating p-Cresyl Sulfate, Non-Hepatic Alkaline Phosphatase and Risk of Bone Fracture Events in Chronic Kidney Disease-Mineral Bone Disease.

Patients with chronic kidney disease (CKD), especially those undergoing hemodialysis, are at a considerably high risk of bone fracture events. Experimental data indicate that uremic toxins intricately involved in bone-related proteins exert multi-faced toxicity on bone cells and tissues, leading to chronic kidney disease–mineral and bone disorder (CKD-MBD). Nonetheless, information regarding the association between p-cresyl sulfate (PCS), non-hepatic alkaline phosphatase (NHALP) and skeletal events remains elusive. We aim to explore the association between PCS, NHALP and risk of bone fracture (BF) in patients with hemodialysis. Plasma concentrations of PCS and NHALP were ascertained at study entry. Cox proportional hazard regression analyses were used to determine unadjusted and adjusted hazard ratios (aHRs) of PCS for BF risk. In multivariable analysis, NHALP was associated with incremental risks of BFs [aHR: 1.06 (95% CI: 1.01–1.11)]. The association between the highest PCS tertile and BF risk remained robust [aHR: 2.87 (95% CI: 1.02–8.09)]. With respect to BF events, the interaction between NHALP and PCS was statistically significant (p value for the interaction term < 0.05). In addition to mineral dysregulation and hyperparathyroidism in hemodialysis patients, higher circulating levels of PCS and NHALP are intricately associated with incremental risk of BF events, indicating that a joint evaluation is more comprehensive than single marker. In light of the extremely high prevalence of CKD-MBD in the hemodialysis population, PCS may act as a pro-osteoporotic toxin and serve as a potential surrogate marker for skeletal events.

Indications of surgical treatment of secondary hyperparathyroidism in hemodialysis patients

Indications of surgical treatment of secondary hyperparathyroidism in hemodialysis patients

Этелкальцетид в лечении вторичного гиперпаратиреоза у пациентов на программном гемодиализе: обзор клинических данных и место в терапии

Этелкальцетид в лечении вторичного гиперпаратиреоза у пациентов на программном гемодиализе: обзор клинических данных и место в терапии

P1571WEEKLY VERSUS MONTHLY ORAL CHOLECALCIFEROL ON OXIDATIVE STRESS AND INFLAMMATORY MARKERS IN HEMODIALYSIS PATIENTS: A PROSPECTIVE RANDOMIZED TRIAL

Abstract Background and Aims Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there’s also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients. However, data is still limited regarding an exact treatment protocols or regimens for vitamin D supplementation in such category. Method A prospective, randomized trial was carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and parathormone (PTH) levels, were all assessed at baseline and at the end of the study. Results Cholecalciferol significantly increased serum levels of 25(OH)D in both groups, with a higher significant increase (p = 0.003) in Group A vs. Group B. Only Group A had a significant decrease in both serum MDA and serum hsCRP levels (p &amp;lt;0.001), while it had a significant higher increase (p = 0.011) in serum SOD when compared to Group B. Regarding PTH levels, a significant higher change from baseline ( -30 pg/mL vs. -3 pg/mL) was noticed in Group A vs. Group B. However, neither calcium nor phosphorus levels had a significant difference in both groups. No side effects were reported from both study groups. Conclusion Weekly (50.000 IU) oral cholecalciferol seems to be an effective safe option to replenish vitamin D levels in hemodialysis patients, with an ameliorating effect on oxidative stress, inflammation and PTH levels.

P1410IMPACT OF VITAMIN D SUPPLEMENTATION ON CKD-MBD HEMODIALYSIS PATIENTS - A PROSPECTIVE STUDY

Abstract Background and Aims There are evidences suggesting that 50-90% of hemodialysis (HD) patients are vitamin D deficient [25(OH) D level &amp;lt;20 ng/mL] or insufficient (between 21 to 29 ng/mL). Recent guidelines recommend evaluation and supplementation low serum vitamin D levels in HD patients. However the effects of supplementation remains uncertain. Our aim was to evaluate the effect of supplementation on phosphocalcic metabolism and secondary hyperparathyroidism in HD patients of a hospital unit. Method Prospective study with an 18 months follow-up period. HD patients were supplemented with 12000 IU cholecalciferol 3 times a week if vitamin D level under 30ng/mL and 4000 IU if above. Every 6 months (3 time points) vitamin D, bone alkaline phosphatase (AF), calcium (Ca2+), phosphorus (P+) and intact parathyroid hormone (iPTH) blood levels were measured. Demographic, analytical and clinical data, including diabetic status, were analyzed. Categorical variables are presented as frequencies and percentages, continuous variables as means and standard deviations, or medians and interquartile ranges (IQR) for variables with skewed distributions. Statistical analysis was performed using SPSS version 21 for Windows. Results Sixty patients completed the follow-up period. The average was 74.70±1.43 years, 65% (n=39) were male and 41.7% (n=25) were diabetic. The average HD time at point 3 (18 months) was 3.15±3.62 years. A repeated measures ANOVA with a Greenhouse-Geisser correction showed that cholecalciferol supplementation significantly changed vitamin D blood levels along time (F(2.492;144.54)=26.832; p&amp;lt;0.001), with a statistically significant increase in vitamin D blood levels from time point 0 to point 3 (+8.27 ng/mL, p&amp;lt;0.001). There was also a significant reduction of phosphorus (-0.53mg/dL, p=0.017) and iPTH blood levels (-144.09 pg/nL p&amp;lt;0.001) in the same period. Seric calcium had a statistically significant increase from point 0 to 2 (+0.22 mg/dL, p=0.038). Using Pearson’s correlation, from point 0 to 3, we found a negative correlation between vitamin D and iPTH blood levels variation (Rs= -0.303, p=0.018) and a positive correlation between vitamin D and AF blood levels variation (Rs= 0.043, p=0.002). Conclusion Oral cholecalciferol supplementation increases significantly vitamin D blood levels and can be a good option in the management of secondary hyperparathyroidism and hypocalcemia. However, one of the limitations of our study was not to evaluate the use of medication such as P+ chelating agents and the small sample size. Therefore, large randomized clinical trials with clinically meaningful endpoints (fracture, hospitalization, parathyroidectomy, death) are still required to assess the usefulness of different vitamin D compounds for CKD and dialysis patients.

Conversion from Intravenous Vitamin D Analogs to Oral Calcitriol in Patients Receiving Maintenance Hemodialysis.

In the United States, intravenous vitamin D analogs are the first-line therapy for management of secondary hyperparathyroidism in hemodialysis patients. Outside the United States, oral calcitriol (1,25-dihydroxyvitamin D3) is routinely used. We examined standard laboratory parameters of patients on in-center hemodialysis receiving intravenous vitamin D who switched to oral calcitriol. We conducted a retrospective cohort study of adult patients treated within Fresenius Kidney Care clinics. During a 6-month period (December 2013 to May 2014), we identified patients on an intravenous vitamin D analog (doxercalciferol or paricalcitol) who switched to oral calcitriol and matched them to patients receiving an intravenous vitamin D analog. Mean serum calcium, phosphate, and intact parathyroid hormone (iPTH) concentrations were examined for up to 12 months of follow-up. We used Poisson and Cox proportional hazards regression models to examine hospitalization and survival rates. The primary analysis was conducted as intention-to-treat; secondary analyses included an as-treated evaluation. A total of 2280 patients who switched to oral calcitriol were matched to 2280 patients receiving intravenous vitamin D. Compared with patients on intravenous vitamin D, mean calcium and phosphate levels in the oral calcitriol group were lower after the change to oral calcitriol. In contrast, iPTH levels were higher in the oral calcitriol group. At 12 months, the percentage of patients with composite laboratories in target range (calcium <10 mg/dl, phosphate 3.0-5.5 mg/dl, and iPTH 150-600 pg/ml) were comparable between groups (45% versus 45%; P=0.96). Hospital admissions, length of hospital stay, and survival were comparable between groups. An as-treated analysis and excluding those receiving cinacalcet did not reveal significant between-group differences. Among patients receiving in-center hemodialysis who were switched to oral calcitriol versus those on an intravenous vitamin D analog, the aggregate of all mineral and bone laboratory parameters in range was largely similar between groups.

Daily versus post-dialysis administration of calcimimetics for the treatment of secondary hyperparathyroidism in haemodialysis patients: an interventional, multi-centre study

This article has been retracted. The retraction notice was published on 06 May 2020: Retraction notice: Daily versus post-dialysis administration of calcimimetics for the treatment of secondary hyperparathyroidism in haemodialysis patients: an interventional, multi-centre study. Afr J Nephrol. 2020; 2391):85.

Retraction notice: Daily versus post-dialysis administration of calcimimetics for the treatment of secondary hyperparathyroidism in haemodialysis patients: an interventional, multi-centre study

The authors of this paper [1] contacted the Journal on 1 May 2020, shortly after its publication on 25 April 2020, and requested that it be retracted because of the following reasons:- the authors did not have permission from the dialysis provider company to publish the data- some data were from different time frames and the related results are therefore inaccurate- consent was not obtained from all patients- some co-authors who should have been included, were not.The editors of the Journal, after consultation with senior members of the editorial board, have decided that the article be retracted and that the relevant institutions and ethics committee be informed.The metadata of the article has been amended to indicate the retraction and the PDF version of the paper, which will remain on the Journal website, now has a watermark indicating “RETRACTED”. Reference1. Demerdash TM, Abdelsalam M, Assem M, Shaheen MM, Marie MA. Daily versus post-dialysis administration of calcimimetics for the treatment of secondary hyperparathyroidism in haemodialysis patients: an interventional, multi-centre study. Afr J Nephrol. 2020; 23(1):81-84.

Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients

IntroductionCalcimimetics improve parameters of secondary hyperparathyroidism (sHPT) but are mostly initiated when patients have severe disease, potentially limiting effectiveness. We evaluated the effects of etelcalcetide on lowering intact parathyroid hormone, calcium, and phosphate at different disease severity levels.MethodsThis analysis examined data from 2 parallel, phase 3, randomized, placebo-controlled, 26-week trials conducted in 1023 adult (≥18 years old) patients with sHPT on maintenance hemodialysis. Etelcalcetide effects by baseline intact parathyroid hormone stratum (<600, 600–1000, and >1000 ng/l) on mean percentage change in intact parathyroid hormone; changes in calcium and phosphate; and achieving serum intact parathyroid hormone ≤300 ng/l, phosphate <1.78 mmol/l, and both combined, were assessed.ResultsEtelcalcetide reduced serum intact parathyroid hormone by a similar percentage across baseline strata. A similar proportion achieved >30% intact parathyroid hormone reduction across strata for the etelcalcetide arms. Parathyroid hormone increased modestly in each placebo-group stratum, most prominently in the lowest stratum. Serum calcium and phosphate concentrations decreased across strata in etelcalcetide-treated patients, with the most pronounced reductions in patients with highest baseline parathyroid hormone. However, the proportion of patients achieving parathyroid hormone, phosphate, and both targets was highest in the lowest baseline parathyroid hormone stratum, where etelcalcetide dose requirements were lowest. Etelcalcetide dose requirement was lowest among patients in the lowest intact parathyroid hormone stratum.ConclusionEtelcalcetide effectively lowered serum intact parathyroid hormone, calcium, and phosphate, irrespective of the severity of secondary hyperparathyroidism. The ability to achieve target goals was greatest, and dose requirement smallest, when etelcalcetide was initiated among patients with the lowest level of disease severity.

Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients

Background: Etelcalcetide is a novel second-generation calcimimetic that, because of its intravenous administration, could improve treatment adherence in secondary hyperparathyroidism (SHPT). The aim of this study was to evaluate the effectiveness of etelcalcetide compared with that of cinacalcet in controlling SHPT in patients under hemodialysis. Methods: A prospective observational study was performed in 29 patients with SHPT under hemodialysis who switched from cinacalcet to etelcalcetide with a follow-up of 6 months. A survey was conducted of adherence to the oral calcimimetic. The primary end-point of the study was to assess whether etelcalcetide was more effective than cinacalcet in controlling SHPT. Results: After the switch of treatment, none of the patients developed clinical intolerance or new adverse effects. Etelcalcetide was more effective than cinacalcet in controlling intact parathyroid hormone (iPTH), with an overall decrease in iPTH levels that was significant from the second month. Average calcium levels remained within the normal range, with a higher percentage of hypocalcemia with etelcalcetide (6.9 vs. 13.8%), which was asymptomatic in all cases. Patients who were nonadherent to cinacalcet (38%) showed a significant reduction in calcium and iPTH during follow-up with etelcalcetide. The adherent group (62%) also showed a trend to lower iPTH levels reaching statistical significance after 5 months of follow-up. The dose conversion factor for the switch from cinacalcet to etelcalcetide was etelcalcetide/session = 0.111*mg cinacalcet/day + 0.96, R² = 0.57. Conclusions: Etelcalcetide was more effective than cinacalcet in this patient population, especially in the nonadherent subgroup, leading to better SHPT control without adverse effects.