scholarly journals Effectiveness of sucroferric oxyhydroxide in patients on on-line hemodiafiltration in real-world clinical practice: A retrospective study

2019 ◽  
Vol 41 (2) ◽  
pp. 224-230
Author(s):  
Aníbal Ferreira ◽  
Bruno Pinto ◽  
David Navarro ◽  
João Aniceto ◽  
Pedro L Neves ◽  
...  
Keyword(s):  
Real World ◽  
Intravenous Iron ◽  
Routine Care ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Pill Burden ◽  
Increased Risk ◽  
On Line ◽  
Phosphorus Levels

Abstract Introduction: Hyperphosphatemia is a serious consequence of chronic kidney disease and has been associated with an increased risk for cardiovascular disease. Controlling serum phosphorus levels in patients on dialysis is a challenge for the clinicians and implies, in most cases, the use of phosphate binders (PB). Part of the reason for this challenge is poor adherence to treatment because of the high pill burden in this patient group. Objective: To assess the real-world effectiveness of sucroferric oxyhydroxide (SO) in controlling serum phosphorus levels and determine the associated pill burden. Methods: A multicenter, quantitative, retrospective, before-after study was conducted with patients receiving online hemodiafiltration. Patients who switched to SO as a part of routine care were included in the study. PB treatment, number of pills, serum phosphorus levels, and intravenous iron medication and dosage were collected monthly during the six months of treatment with either PB or SO. Results: A total of 42 patients were included in the study. After switching from a PB to SO, the prescribed pills/day was reduced 67% from 6 pills/day to 2 pills/day (p < 0.001) and the frequency of pill intake was lowered from 3 times/day to 2 times/day (p < 0.001). During the treatment with SO, the proportion of patients with serum phosphorus ≤ 5.5 mg/dL increased from 33.3% at baseline to 45% after six months of treatment. Conclusion: During the six-month follow-up with SO, serum phosphorus levels were controlled with one third of the pills/day compared to other PB.

scholarly journals Real-World Scenario Improvements in Serum Phosphorus Levels and Pill Burden in Peritoneal Dialysis Patients Treated with Sucroferric Oxyhydroxide

2018 ◽  
Vol 47 (3) ◽  
pp. 153-161 ◽  
Author(s):  
Kamyar Kalantar-Zadeh ◽  
Vidhya Parameswaran ◽  
Linda H. Ficociello ◽  
Ludmila Anderson ◽  
Norma J. Ofsthun ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Routine Care ◽  
Serum Phosphorus ◽  
Pill Burden ◽  
Dialysis Patients ◽  
Database Analysis ◽  
Baseline Serum ◽  
The Mean ◽  
Phosphorus Levels

Background: A database analysis was conducted to assess the effectiveness of sucroferric oxyhydroxide (SO) on lowering serum phosphorus and phosphate binder (PB) pill burden among adult peritoneal dialysis (PD) patients prescribed SO as part of routine care. Methods: Adult PD patients (n = 258) prescribed SO through a renal pharmacy service were analyzed. Baseline was 3 months before SO prescription. SO-treated follow-up was for 6 months or until either a new PB was prescribed, SO was not refilled, PD modality changed, or patient was discharged. In-range serum phosphorus was defined as ≤5.5 mg/dL. Results: At baseline, mean serum phosphorus was 6.59 mg/dL with 10 prescribed PB pills/day. The proportion of patients achieving in-range serum phosphorus increased by 72% from baseline to month 6. Prescribed PB pills/day decreased by 57% (10 at baseline to 4.3 at SO follow-up, p < 0.0001). The mean length of SO follow-up was 5.1 months; SO follow-up ended for 38, 27, and 50 patients at months 4, 5, and 6, respectively, due to no further PB fills, and for 10, 11, and 4 patients at months 4, 5, and 6, respectively, due to another PB prescribed. In patients with baseline serum phosphorus >5.5 mg/dL who achieved in-range serum phosphorus during SO follow-up for ≥1 quarter, a notable improvement in serum phosphorus (6.54 to 5.10 mg/dL, p < 0.0001) was observed, and there was a 53% reduction in PB pill burden (9.9 to 4.7, p < 0.0001). Conclusion: Among PD patients prescribed SO as part of routine care, improvements in serum phosphorus control and >50% reduction in PB pills/day were observed.

scholarly journals P1404A PHASE 2 OPEN-LABEL, SINGLE-ARM, FIRST JAPANESE STUDY OF TENAPANOR, A NOVEL PHOSPHATE ABSORPTION INHIBITOR, FOCUSING ON PILL BURDEN DECREASE IN PATIENTS WITH HYPERPHOSPHATEMIA UNDERGOING HEMODIALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Tadao Akizawa ◽  
Hironori Kanda ◽  
Masayuki Takanuma ◽  
Jun Kinoshita ◽  
Masafumi Fukagawa
Keyword(s):  
Primary Endpoint ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Pill Burden ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Open Label ◽  
Serious Adverse Events ◽  
Phosphate Absorption ◽  
Phosphorus Control

Abstract Background and Aims Phosphate binders (PB) are usually prescribed to dialysis patients with hyperphosphatemia. Several studies have reported that higher PB pill burden may reduce adherence and lead to insufficient phosphorus control. Tenapanor is an investigational, minimally absorbed, orally administered, non-binder, small-molecule that inhibits the sodium/hydrogen exchanger isoform 3 (NHE3) in development for the control of serum phosphorus. A previous Ph3 study sponsored by Ardelyx, Inc. (NCT02675998) showed a significant phosphorus decrease compared to the placebo in patients with hyperphosphatemia undergoing hemodialysis (HD) in the US. Tenapanor was expected to reduce PB pill burden since it is administered as one small pill, taken twice a day. This was the first study in Japanese HD patients, which aimed to confirm whether tenapanor reduces the pill burden of PB. Method This was a multicenter, open-label, single-arm Ph2 study. The study consists of a screening period, a 3-week observation period, and a 26-week treatment period. Patients whose serum phosphorus level was ≥ 3.5 and ≤ 7.0 mg/dL, taking at least two PB pills three times a day were enrolled. The patients started to receive 30 mg of tenapanor twice daily. The tenapanor dose could be reduced in a step-wise manner (60, 40, 20 and 10 mg/day) at the investigator’s discretion, based on GI tolerability. PB treatment was continued according to individual regimens, however, the dose could be adjusted appropriately to maintain serum phosphorus level within ±0.5 mg/dL from the baseline. The primary endpoint was an achievement of at least a 30% decrease in the mean of the total number of PB and tenapanor pills compared to the number of PB pills at baseline. The proportion of patients who achieved at least a 30 % decrease were tested using binomial test with a threshold level of 20% and a one-sided significance level of 0.025. The analysis was conducted using the data as of Dec25, 2019. Results The primary endpoint was met. Of 67 enrolled patients at the timing of analysis, 48 patients (71.6%, [95% CI: 59.3% - 82.0%], p&lt;0.001) achieved a 30% decrease in the total number of PB and tenapanor pills, and of those, 35 patients (52.2%, [95% CI: 39.7% - 64.6%]) achieved a 50% decrease and 18 patients (26.9%) no longer required the use of any PB at week 26. Mean phosphorus levels were maintained during the study from 5.2 mg/dL at the baseline to 4.7 mg/dL at week 26. The most frequent adverse event was diarrhea (76.1%), which was mostly mild to moderate. Only four patients discontinued the study due to diarrhea. Serious adverse events were reported in five patients, only two of which were related to tenapanor (diarrhea and acute myocardial infarction). Conclusion Tenapanor was able to provide phosphorus control with significantly fewer pills compared to PB. AE profile was similar to previous US studies. This result suggests that tenapanor, a non-binder, phosphate absorption inhibitor that provides a novel approach to the management of hyperphosphatemia, could potentially improve drug adherence by reducing PB pill burden while maintaining effective phosphorus control.

FC 100ASSOCIATION OF SINGLE AND SERIAL MEASURES OF SERUM PHOSPHORUS WITH ADVERSE OUTCOMES IN PATIENTS ON PERITONEAL DIALYSIS: RESULTS FROM THE INTERNATIONAL PDOPPS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Marcelo Lopes ◽  
Angelo Karaboyas ◽  
David W Johnson ◽  
Talerngsak Kanjanabuch ◽  
Martin Wilkie ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Adverse Outcomes ◽  
Serum Phosphorus ◽  
Target Range ◽  
Recent Measurement ◽  
Baseline Serum ◽  
All Cause Mortality ◽  
Serial Measurements ◽  
Phosphorus Levels

Abstract Background and Aims While it has been established that high serum phosphorus is associated with mortality in hemodialysis (HD) patients, there is limited evidence in the peritoneal dialysis (PD) setting. We evaluated the association of serum phosphorus with mortality and major adverse cardiovascular events (MACE) in patients on PD, and investigated various parameterizations using single and serial measurements of serum phosphorus. Method We utilized data from 7 countries in phase 1 (2014-2017) of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Australia, Canada, Japan, New Zealand, Thailand, the UK, and the US. We investigated the association of serum phosphorus and 3 outcomes: all-cause mortality, cardiovascular (CV) mortality, and MACE (CV mortality + non-fatal angina, myocardial infarction, stroke, and heart failure). We parameterized serum phosphorus using 4 different methods: (1) single measurement of baseline serum phosphorus [most recent measurement during 6-month run-in period]; (2) mean serum phosphorus over a 6-month run-in period; (3) number of months (over the past 6 months) with serum phosphorus above the target range (&gt;4.5 mg/dL); (4) mean area-under-the-curve (AUC), calculated as the average amount of time spent with serum phosphorus &gt;4.5 mg/dL multiplied by the extent to which this threshold was exceeded over 6 months. Cox regression was used to estimate the association between each of these 4 exposures with the time-to-event outcomes, in models thoroughly adjusted for possible confounders. Follow-up began after the 6-month run-in period and continued until the outcome occurred, 7 days after leaving the facility due to transfer or change in kidney replacement therapy modality, loss to follow-up, or end of study phase (whichever event occurred first). Results Our sample consisted of 5904 patients who were on PD. Those with higher serum phosphorus levels were younger and had lower hemoglobin levels. Compared to patients with serum phosphorus ≥3.5 to &lt;4.5 mg/dL, we found an all-cause mortality hazard ratio (HR) of 1.62 (95% CI: 1.19, 2.20) for patients with serum phosphorus ≥ 7 mg/dL. Strong associations were also observed using serial phosphorus measures [Table]. For example, compared to the reference group of AUC=0, the HR (95% CI) of death was 1.49 (1.10, 2.00) for AUC &gt;1 to 2; and 1.67 (1.15, 2.41) for AUC &gt;2. Akaike Information Criteria (AIC) results showed that, among the 4 exposures, AUC was the strongest predictor of all-cause mortality, and the single phosphorus measure was the weakest predictor. Associations between serum phosphorus and adverse outcomes were generally stronger for CV death and MACE than for all-cause mortality [Table]. Conclusion As seen in HD patients, this analysis demonstrates that serum phosphorus is a strong predictor of adverse outcomes in patients on PD. When considering serial measurements of serum phosphorus, rates of adverse events began to rise at phosphorus levels &gt;4.5 mg/dL. As recommended by KDIGO guidelines, serial measurements that consider a history of serum phosphorus excursions &gt;4.5 mg/dL should be considered when assessing risks of adverse outcomes.

scholarly journals Stroke in hemodialysis patients randomized to different intravenous iron strategies: a prespecified analysis from the PIVOTAL trial

Kidney360 ◽  
2021 ◽  
pp. 10.34067/KID.0004272021
Author(s):  
Patrick B. Mark ◽  
Pardeep S. Jhund ◽  
Matthew R. Walters ◽  
Mark C. Petrie ◽  
Albert Power ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stroke Risk ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Hemodialysis Patients ◽  
High Dose ◽  
Pivotal Trial ◽  
Increased Risk ◽  
Iv Iron

Background: People with kidney failure treated with hemodialysis (HD) are at increased risk of stroke compared to similarly aged people with normal kidney function. One concern is that treatment of renal anemia might increase stroke risk. We studied risk factors for stroke in a prespecified secondary analysis of a randomized controlled trial of intravenous iron treatment strategies in HD. Methods: We analyzed data from the Proactive IV IrOn Therapy in HaemodiALysis Patients (PIVOTAL) trial focusing on variables associated with risk of stroke. The trial randomized 2,141 adults, who had started hemodialysis <12 months earlier and who were receiving an erythropoiesis-stimulating agent (ESA), to high-dose IV iron administered proactively or low-dose IV iron administered reactively in a 1:1 ratio. Possible stroke events were independently adjudicated. We performed analyses to identify variables associated with stroke during follow-up and assessed survival following stroke. Results: During a median 2.1 years follow-up, 69 (3.2%) patients experienced a first post randomization stroke. 57 (82.6%) were ischemic strokes and 12 (17.4%) hemorrhagic strokes. There were 34 post randomization strokes in the proactive arm and 35 in the reactive arm (hazard ratio (95% confidence interval): 0.90 (0.56, 1.44), p=0.66). In multivariable models, female gender, diabetes, history of prior stroke at baseline, higher baseline systolic blood pressure, lower serum albumin and higher C-reactive protein were independently associated with stroke events during follow up. Hemoglobin, total iron or ESA dose were not associated with risk of stroke. 58% of patients with a stroke event died during follow-up, compared to 23% without a stroke. Conclusions: In hemodialysis patients, stroke risk is broadly associated with risk factors previously described to increase cardiovascular risk in this population. Proactive intravenous iron does not increase stroke risk.

Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

2022 ◽  
pp. annrheumdis-2021-221915
Author(s):  
Farzin Khosrow-Khavar ◽  
Seoyoung C Kim ◽  
Hemin Lee ◽  
Su Been Lee ◽  
Rishi J Desai
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Fixed Effects ◽  
Safety Concern ◽  
Specific Effect ◽  
Routine Care ◽  
Cardiovascular Outcomes ◽  
The Real ◽  
Real World Setting ◽  
Increased Risk

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.

scholarly journals Changes in serum albumin and other nutritional markers when using sucroferric oxyhydroxide as phosphate binder among hemodialysis patients: a historical cohort study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Kamyar Kalantar-Zadeh ◽  
Linda H. Ficociello ◽  
Vidhya Parameswaran ◽  
Nicolaos V. Athienites ◽  
Claudy Mullon ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Dietary Intake ◽  
Phosphate Binder ◽  
Clinical Care ◽  
Elevated Serum ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Pill Burden ◽  
Historical Cohort ◽  
Phosphorus Levels

Abstract Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein. Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients (N = 79) switched to SO were also examined. Results SO therapy was associated with a mean reduction of 45.7 and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively (P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group. Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

Low Calcium Dialysate and Hyperparathyroidism

1996 ◽  
Vol 16 (1_suppl) ◽  
pp. 499-503 ◽  
Author(s):  
Rachel Duncan ◽  
Tracey Cochrane ◽  
Carol Bhalla ◽  
Jonathan Michael ◽  
Nicholas Talbot Richards ◽  
...  
Keyword(s):  
Parathyroid Hormone ◽  
High Serum ◽  
Phosphate Binders ◽  
Serum Parathyroid Hormone ◽  
Aluminum Salts ◽  
Low Calcium ◽  
Increased Risk ◽  
Intact Molecule ◽  
Alkaline Phosphate

A low calcium dialysate reduces hypercalcemia from calcium-containing phosphate binders and makes phosphate control possible without the use of aluminum salts. We asked whether this might, however, lead to hyperparathyroidism. We prospectively studied serum concentrations of parathyroid hormone levels (by an immunoreactive intact molecule assay) in 173 patients on continuous ambulatory peritoneal dialysis (CAPD) who were started on a low calcium dialysate (Ca2+ 1.25 or 1.00 mmol/L) because of hypercalcemia. Median follow-up was 13.2 months (range 1 -28). Initial serum parathyroid hormone was [median (range)]: 70 (5 -1043) ng/L pre low calcium dialysate, and this rose to 130(5 -914) ng/LatO 6 months; 130 (5 -1030) ng/Lat 6 -12 months; 170 (170 1400) ng/L at 12 -18 months; and 130 (5 -1200) ng/L at 18 24 months (p = 0.0006). Twenty-two patients required a parathyroidectomy because of a sustained rise in parathyroid hormone that was not responsive to alfacalcidol and hypercalcemia. Initial serum parathyroid hormone was significantly higher in these patients at 359 (5 1073) ng/L as compared to a level of 69.5 (6 1147) ng/L in patients who did not have a parathyroidectomy (p = 0.0009). There was a significant sustained fall in mean serum corrected calcium from 2.77 (2.37 3.51) mmol/L to 2.53 (1.39 3.20) mmol/L at three months (p = 0.0006), a nonsignificant rise in mean serum alkaline phosphate from 179 (47 -1858) mmol/L to 191 (55 -1821) mmol/L (p = 0.15), and a fall in mean serum phosphate levels from 1.87 (0.59–3.18) mmol/L to 1.68 (0.45–3.6) mmol/L (p = 0.76). Our data suggest that the benefits of a low calcium dialysate in CAPD patients are balanced by an increased risk of hyperparathyroidism, and that this risk is higher in patients with an initially high serum parathyroid hormone level.

Phosphorus Counting Table for the control of serum phosphorus levels without phosphate binders in hemodialysis patients

2019 ◽  
Vol 32 ◽  
pp. 153-157 ◽  
Author(s):  
Vivianne Rêis Bertonsello-Catto ◽  
Leandro Junior Lucca ◽  
José Abrão Cardeal da Costa
Keyword(s):  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Phosphorus Levels
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