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

2019 ◽  
Vol 48 (2) ◽  
pp. 106-114 ◽  
Author(s):  
Marc Xipell ◽  
Enrique Montagud-Marrahi ◽  
María Victoria Rubio ◽  
Raquel Ojeda ◽  
Marta Arias-Guillén ◽  
...  

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.

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Tsung-Liang Ma ◽  
Peir-Haur Hung ◽  
Ing-Ching Jong ◽  
Chih-Yen Hiao ◽  
Yueh-Han Hsu ◽  
...  

Secondary hyperparathyroidism increases morbidity and mortality in hemodialysis patients. The Kidney Disease Outcomes Quality Initiative Guidelines recommend parathyroidectomy for patients with chronic kidney disease and parathyroid hormone concentrations exceeding 800 pg/mL; however, this concentration represents an arbitrary cut-off value. The present study was conducted to identify factors influencing mortality in hemodialysis patients with parathyroid hormone concentrations exceeding 800 pg/mL and to evaluate the effects of parathyroidectomy on outcome for these patients. Two hundred twenty-one hemodialysis patients with parathyroid hormone concentrations > 800 pg/mL from July 2004 to June 2010 were identified. 21.1% of patients (n = 60) received parathyroidectomy and 14.9% of patients (n = 33) died during a mean follow-up of 36 months. Patients with parathyroidectomy were found to have lower all-cause mortality (adjusted hazard ratio [aHR]: 0.34). Other independent predictors included age ≥ 65 years (aHR: 2.11) and diabetes mellitus (aHR: 3.80). For cardiovascular mortality, parathyroidectomy was associated with lower mortality (HR = 0.31) but with a marginal statistical significance (p = 0.061). In multivariate analysis, diabetes was the only significant predictor (aHR: 3.14). It is concluded that, for hemodialysis patients with parathyroid hormone concentrations greater than 800 pg/mL, parathyroidectomy is associated with reduced all-cause mortality.


2021 ◽  
Vol 15 (5) ◽  
pp. 1205-1207
Author(s):  
R. A. Khan ◽  
A. Ali ◽  
S. Munib ◽  
I. Muhammad ◽  
NOSHER WAN ◽  
...  

Objective: The aim of this study is to determine the response of sofosbuvir and velpatasvir combination in chronic hepatitis C with hemodialysis patients. Study Design: Prospective/observational study Place and Duration: The study was conducted at department of Nephrology Nawaz Sharif Kidney Hospital, Swat for duration of six months from 1st July to 31st December, 2020. Methods: Total 27 patients of both genders were presented in this study. Patients were aged between 18-85 years. Patients details demographics age, sex and body mass index were recorded after taking written consent. Patients diagnosis hepatitis C with recognized genotypes were presented. Enrolled patients received combination of sofosbuvir and velpatasvir regime (SOF/VLP) for 14 weeks and follow up was taken. Effectiveness and safety among HCV patients on hemodialysis were observed. Complete data was analyzed by SPSS 22.0 version. Results: Out of 27 patients 17 (62.96%) were males 10 (37.04%) were females. Mean age of the patients was 35.14±5.18 years with mean BMI 24.41±6.25 kg/m2. Hypertension was the most common comorbidity found in 15 (55.55%) patients followed by obesity 8 (29.63%) and diabetes found in 3 (14.81%). Among 27 cases 20 (74.04%) were naïve and 7 (25.96%) were treatment experienced. Sustained virological response was found in 26 (96.3%) and 1(3.7%) patients were lost at follow up. Significantly improvement was found in hemoglobin level 12.11 ± 5.24, alanine aminotransferase (ALT) 28.51 ± 9.62 and aspartate aminotransferase (AST) 35.24 ± 7.08 after treatment. Headache, fatigue and nausea were the most common adverse outcomes. Conclusion: We concluded in this study that the use of sofosbuvir and velpatasvir was effective safe and well tolerated in the treatment of hepatitis C patients with hemodialysis. Keywords: Hemodialysis, Hepatitis C, Sofosbuvir, Velpatasvir, Complications


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Niansong Wang ◽  
Gengru Jiang

Abstract Background and Aims The aim of this retrospective, real-world data based observational study was to evaluate the efficacy, safety profile of paricalcitol in Chinese hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT) under routine clinical practice. Method From the Zemplar Engagement Program (ZEP) database, a total of 668 Chinese hemodialysis patients from 104 dialysis centers between January 2015 and May 2019 were included in the analysis set. Intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphate (P), dosage of intravenous (IV) paricalcitol (Zemplar®) were analyzed and discussed via retrospective analysis of the database during the treatment. The comparison between baseline and end of treatment was made to reveal the fluctuation trend of each biomarker and reflected us with clues of IV paricalcitol’s algorithm in real-world practice. Results Patients were divided into five groups according to the duration of follow-up, which includes Month 0.5-3 (Day 14–90), Month 3-6 (Day 91–180), Month 6-12 (Day 181–360), Month 12-24 (Day 361–720) and Month 24-48 (Day 721–1440). Median iPTH levels decreased from 1183.05 pg/ml at baseline to 676.03 pg/ml at last visit by 30.88% (p < 0.0001). 56.14% of patients had a ≥30% decrease and 29.34% of patients had a ≥50% decrease in iPTH. The proportion of patients achieving the Chinese CKD-MBD Guideline target range (<600 pg/ml) increased from 9.88% at treatment initiation to 40.12% at last observation. Serum Ca levels remained within the normal range throughout the study with only a slight but statistically significant increase in the group of Month 12-24 (P=0.0479). Serum phosphate remained stable in all follow-up groups (P>0.05). Subgroup analyses of 221 patients with hyperphosphatemia at baseline >1.78 mmol/l showed a rapid phosphate reduction from 2.00±0.20 mmol/l to 1.76±0.34mmol/l by 11.64% (P< 0.0001), within the first few weeks, along with the reduction of iPTH. Of all patients, 62.72% experienced a 30% decrease in iPTH within a median time of 16.86 weeks (95% CI, 15.57-17.86), 38.17% experienced a 50% decrease in iPTH within a median time of 21.29 weeks (95% CI, 19.86-23.14). The average weekly dose of paricalcitol was 19.69±8.99ug/week. Total dose of paricalcitol used and baseline iPTH were negatively correlated with the decrease in iPTH. Conclusion This is the first national retrospective real-world observational study since IV paricalcitol is available in China since 2014. It proves that up to 20ug weekly IV paricalcitol treatment is safe and effective in China HD patients with higher iPTH level. Physicians and patients could expect significantly iPTH decrease within 16-21 weeks when IV paricalcitol is initiated. This study also encores the pre-published results of paricalcitol trials and high-quality cohorts, from the real-world perspective. In summary, IV paricalcitol is well tolerated and serves as an effective approach to treat SHPT in Chinese HD patients. Figure.1 Mean iPTH values from baseline to last measurement (pg/ml) Figure.2 iPTH changes compared with baseline stratified by baseline iPTH values (%) Figure.3 Proportion of patients with a >=30% or 50% decrease in parathyroid hormone (%) Figure.4 Changes of iPTH and P from baseline to last measurement in the subgroup of hyperphosphatemia (Mean ± SD); (Hyperphosphatemia, defined as P>1.78 mmol/l)


2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Yachung Jeng ◽  
Paik Seong Lim ◽  
Ming Ying Wu ◽  
Tien-Yu Tseng ◽  
Chang Hsu Chen ◽  
...  

Despite the continuous progression in dialysis medicine, mortality and the burden of cardiovascular disease (CVD) among hemodialysis patients are still substantial. Substantial evidence suggests that proinflammatory (CD16+) monocytes contribute to the development of atherosclerosis. A cohort of 136 stable hemodialysis patients (follow-up: 6.25 year) was assessed to investigate the association between the proportion of CD16+ monocytes for all-cause and CVD mortalities. The CD16+ monocytes were associated with both mortalities after adjusting for a preexisting CVD history. Compared to the reference group (CD16+ monocytes within [15.6–18.6], the first and second quartile), patients with CD16+ monocytes above the highest quartile level (>21.5) had an adjusted hazard ratio (HR) of 30.85 (95% confidence interval [CI]: 7.12–133.8) for CVD mortality and 5.28 (2.07–13.49) for all-cause mortality, and those with CD16+ monocytes below the lowest quartile ≤15.6), had significantly elevated death risks after 3.5-year follow-up (HR [95% CI]: 10.9 [2.42–48.96] and 4.38 [1.45–13.24] for CV and all-cause mortalities, respectively). The hemodialysis patients with CD16+ monocyte level in a low but mostly covering normal range also portended a poor prognosis. The findings shed some light for nephrologists on future prospects of early recognizing immune dysfunction and improving early intervention outcomes.


2021 ◽  
Vol 5 (3) ◽  
pp. 088-094
Author(s):  
Massimetti Carlo ◽  
Bellasi Antonio ◽  
Feriozzi Sandro

Aim: Secondary hyperparathyroidism (SHPT) is an often underestimated cause of anemia in hemodialysis (HD) patients. The aim of this study was to assess the effect of pharmacological correction of SHPT on anemia and erythropoiesis-stimulating agents (ESAs) need. Methods: For the purpose of this retrospective pre-post observational study, we selected 55 HD patients, receiving HD at one single center, in the period from January 2005 to December 2020. The follow-up (F-U) lasted 12 months. The selection criteria were parathormone (PTH) levels > 300 pg/ mL, and hemoglobin (Hb) levels < 11 g/dL, despite treatment with ESAs. Parametric and non-parametric tests were used when appropriate. In the light of exploratory nature of the study, the limited sample size and in consideration of the pre-post-design, no further adjustment for potential confounders is performed. Results: The hemoglobin levels throughout the study were correlated to serum PTH (r = -.257, p < 0.01). At the end of the F-U, in the 40 patients whose PTH levels decreased ≥ 30% (responders group) Hb levels increased from 10.3 ± 0.5 g/dL to 12.2 ± 1.1 g/dL (p < 0.001), and ESAs doses decreased from 141 ± 101 IU/kg/b.w./week to 94 ± 76 IU/kg/b.w./week (p < 0.05). On the contrary, in the non-responders group Hb levels did not change 10.3 ± 0.5 gr/dL at baseline and 10.1 ± 1.1 gr/dL at F-U (P = NS), and the mean doses of ESAs increased from 144 ± 75 IU/kg/b.w./week to 218 ± 145 IU/kg/b.w./week (P = NS). Conclusion: Adequate control of SHPT is associated with concomitant improvement of anemia and decrease in ESAs need. Future endeavors are required to confirm these preliminary results.


2019 ◽  
Vol 51 (1) ◽  
pp. 65-73
Author(s):  
Qiang Ma ◽  
Dechun Su ◽  
Fen Liu ◽  
Haidong Xing ◽  
Xue Han ◽  
...  

Background: Successful parathyroidectomy (PTX) with stable postoperative parathyroid hormone (PTH) levels is associated with the stabilization of coronary artery calcification score (CACS) in patients with severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis. To use computed tomography (CT) to evaluate the influence of PTX on CACS in asymptomatic patients. Methods: This study was performed with institutional review board approval. Written consent was obtained from each patient. Forty-eight patients (mean age ± SD 54.50 ± 13.14 years; range 33–77 years) undergoing maintenance hemodialysis who underwent PTX and 56 patients (mean age 55.28 ± 12.32 years; range 35–76 years) who did not undergo PTX received prospective follow-up for 2 years. CACS was quantitatively performed using the Agatston method after CT scan. The differences between baseline and end-of-study PTX parameters were analyzed with the paired Student t test. Results: For patients who underwent PTX, mean square root of CACS did not increase from 23.16 ± 18.58 to 23.68 ± 18.16 (t = 1.846, p = 0.072) from baseline to follow-up. In patients who did not undergo PTX, mean square root of CACS increased from 20.21 ± 16.47 to 28.72 ± 20.95 (t = 10.110, p < 0.001) from baseline to follow-up. In addition, the median annual progression rate of CACS was lower among PTX patients (4.89%), compared with the marked annual progression rate of CACS in non-PTX patients (52.81%; t = 11.264, p < 0.001). Conclusion: Dysregulation of calcium and phosphate metabolism caused by SHPT may result in significant CAC progression in asymptomatic hemodialysis patients. Low PTH state after PTX may stabilize CAC progression in hemodialysis patients.


2019 ◽  
Vol 12 (6) ◽  
pp. 871-879 ◽  
Author(s):  
Jacques Rottembourg ◽  
Pablo Ureña-Torres ◽  
Daniel Toledano ◽  
Victor Gueutin ◽  
Abdelaziz Hamani ◽  
...  

Abstract Background Secondary hyperparathyroidism (SHPT) is frequent in haemodialysis (HD) patients. Oral cinacalcet-hydrochloride (HCl) decreases parathyroid hormone (PTH); however, real-life PTH data, according to Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, are still lacking. Our goal is to assess the percentage of cinacalcet-HCl-treated HD patients with controlled SHPT (PTH &lt;9× upper limit of the normal range) after 12 months (M12) of treatment. Methods This is a retrospective observational study in HD patients with SHPT treated by cinacalcet-HCl between 2005 and 2015 and dialysed in seven French HD centres using the same database (Hemodial™). Results The study included 1268 patients with a mean (standard deviation) follow-up of 21 ± 12 months. Their mean dialysis vintage was 4.3 ± 5.6 years. PTH values were available and exploitable at M12 in 50% of them (645 patients). Among these patients, 58.9% had controlled (mean PTH of 304 ± 158 pg/mL) and 41.1% uncontrolled SHPT (mean PTH of 1084 ± 543) at M12. At the baseline, patients with controlled SHPT were older (66 ± 15 versus 61 ± 17 years), and had lower PTH (831 ± 346 versus 1057 ± 480 pg/mL) and calcaemia (2.18 ± 0.2 versus 2.22 ± 0.19 mmol/L) than uncontrolled patients. In multivariate analysis, these three factors still remained significantly associated with controlled SHPT. Conclusion In this real-life study, 41.1% of HD patients with SHPT treated with cinacalcet-HCl remained with a PTH above the KDIGO recommended target after 12 months of treatment. Apart from the possibility of non-compliance, the severity of SHPT appears to be a major factor determining the response to cinacalcet-HCl treatment, reinforcing the importance of treating SHPT at earlier stages.


Author(s):  
Mi Tian ◽  
Xiaoyu Zhang ◽  
Weijun Jian ◽  
Ling Sun ◽  
Yang Shen ◽  
...  

Background: Keratectasia after corneal refractive surgery is a rare but serious postoperative complication, and reports on accelerated transepithelial corneal crosslinking (ATE-CXL)-based treatment of patients with post-laser-assisted in situ keratomileusis (LASIK) ectasia are limited. Therefore, this study evaluated the long-term efficacy and safety of ATE-CXL for progressive post-LASIK ectasia.Methods: This prospective observational study was conducted at the Eye and ENT Hospital, Fudan University, Shanghai, China, and 25 eyes from 25 patients with post-LASIK ectasia undergoing ATE-CXL were examined. Clinical examinations were conducted preoperatively and postoperatively to assess parameters such as manifest refraction, corrected distance visual acuity (CDVA), endothelial cell density; keratometry, corneal thickness, posterior elevation and topometric indices were measured using Pentacam; sectoral pachymetry and epithelial thickness were evaluated using optical coherence tomography. A paired t-test, Wilcoxon rank-sum test, Kruskal-Wallis test, and repeated measures analysis of variance were used for statistical analysis.Results: Participants were examined for an average of 46 months. No severe complications occurred during or after ATE-CXL. CDVA improved from 0.25 ± 0.31 preoperatively to 0.15 ± 0.17 postoperatively (p = 0.011). Maximum keratometry decreased from 55.20 ± 8.33 D to 54.40 ± 7.98 D, with no statistical significance (p = 0.074), and the central corneal thickness increased from 414.92 ± 40.96 μm to 420.28 ± 44.78 μm (p = 0.047) at the final follow-up. Posterior elevation, pachymetry, and epithelial thickness remained stable (p &gt; 0.05) throughout the follow-up. No significant differences were noted in topometric indices, except the central keratoconus index, which decreased significantly (p &lt; 0.001) at the final follow-up.Conclusion: Improvements in CDVA and stabilization in corneal keratometry and posterior elevation after ATE-CXL were noted at the 46-months follow-up, demonstrating that ATE-CXL is a safe and effective treatment for progressive post-LASIK ectasia.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Diego Barbieri ◽  
ANDRÉS FELIPE DELGADO ◽  
Ana García-Prieto ◽  
Almudena Vega ◽  
Soraya Abad Esttebanez ◽  
...  

Abstract Background and Aims Retention of ß2microglobulin (ß2M), an uremic toxin in the middle molecular range, has been associated with cardiovascular morbidity and mortality in dialysis patients. Although ß2M levels are usually measured in hemodialysis patients, this practice is not common among peritoneal dialysis (PD) patients. The aim of this study is to evaluate the evolution of serum ß2M levels in incident PD patients. Method Prospective, observational study including incident PD patients in our hospital from January 2015 to October 2019. Patients with cardiorrenal syndrome or patients coming from hemodialysis were excluded. Serum ß2M levels were collected before starting PD and during follow up. Weekly KtV, residual renal function and cardiovascular events were also collected during follow up. Results We included 30 patients with a mean age of 57 +/- 17 years. 56.3% were male and 15.6% were diabetic. Mean follow up was 19.8 +/- 16.9 months. 18 patients were on continous ambulatory PD and 12 in automated PD. Mean serum ß2M levels before starting PD were 12.8 +/- 6.6 mg/l and they remained stable during follow up (12.9 +/- 5.2 mg/l, 15 +/- 4.2 mg/l, 14.3 +/- 6.9 mg/l, 10.2+/- 4.5 mg/l at month 6, 12, 24 and 36, respectively; p NS). No differences in serum ß2M levels were observed between continous ambulatory PD and automated PD. Serum ß2M levels were inversely and significantly correlated with weekly KtV (r= -0.943; p 0.009) and residual renal function (r= -0.829; p 0.042). One cardiovascular event was recorded during follow up. Conclusion Serum ß2M levels remain stable during follow up in our cohort of incident PD patients and is significantly and inversely correlated with weekly KtV and residual renal function. Serum ß2M levels monitoring could be helpful in these patients and would yield important information in this population.


2007 ◽  
Vol 135 (1-2) ◽  
pp. 21-25 ◽  
Author(s):  
Vera Jelic ◽  
Goran Milasinovic ◽  
Sinisa Pavlovic ◽  
Vladimir Kanjuh ◽  
Mirjana Zivkovic

Introduction: Brain natriuretic peptide (BNP) has a role in control of cardiovascular and renal functions. Objective The objective was to assess the predictive value of BNP levels for development of heart failure in patients with permanent pacemakers. Method In patients with implanted DDD pacemakers, BNP levels were measured at rest and after exercise testing, on DDD and VVI modes. There were 42 patients (25 males; 59.5%), without symptoms or signs of coronary disease or heart failure, and with normal echocardiograms. According to BNP levels, the patients were divided into three groups: with BNP levels lower than 80 pg/ml, BNP ranging from 81-150 pg/ml, and BNP levels over 151 pg/ml. Results In the first group (27 patients), BNP levels were significantly higher on VVI compared to DDD mode, both at rest and after exercise (p<0.01), with all BNP levels within normal range. In the second group (5 pts), BNP levels at rest were also significantly higher on VVI than on DDD mode, p<0.05. After exercise, these values were also higher on VVI compared to DDD mode, but without statistical significance. The third group (10 pts) as a whole had higher BNP values on VVI compared to DDD mode, with no statistical significance. In patients from this group who later developed heart failure, BNP levels were found to be significantly lower on DDD as opposed to VVI mode at rest, p<0.05, and even higher significance was found after exercise, p<0.01. After 6-year follow-up, 2 out of 5 patients from the second group developed dilated cardiomyopathy, and 8/10 patients in the third group experienced heart failure with LV EF 34.1?10%, LV EDD 6.1?0.42 cm, LV ESD 4.8?0.45 cm. Five of these patients died within the follow-up period. Conclusion The increased BNP levels can be valuable for early screening of patients with higher risk of heart failure. In patients with increased BNP at the time of pacemaker implantation, DDD pacing is a modality of choice.


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