Background and objectives The calcimimetic cinacalcet reduced the risk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients.Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified.Results Older patients had higher baseline prevalence of diabetes mellitus and CV comorbidity. Annualized rates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. ConclusionsIn the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone.
Background and Aims The myeloma cast nephropathy is largely associated with the production of intact immunoglobulin and free light chains (FLC) by a plasma cells monoclone. The use of high-flux hemodiafiltration (HDF) contributes to a decrease in the concentration of FLC. However, it is not always possible to achieve the required substitute volume with acute kidney injury (AKI) emergency treatment. An alternative to HDF could be the usage of membranes with a medium cut-off (expanded hemodialysis (HD), Expanded HD). The aim of this study was to compare the degree of reduction in FLC concentration using conventional HD, HDF and Expanded HD. Method The study includes patients with newly diagnosed multiple myeloma who presented indications for HD therapy start. Procedures were performed on a daily basis from the moment when indications for HD therapy were identified. The duration of the first three procedures was 2 hours. Consistently for each patient the first procedure was carried out using a standard low-flow filter, the second - using a high-flow dialyzer and HDF (substitute volume 9 liters for 2 hours), the third - using a Theranova 400 filter (Baxter, Germany). The concentrations of FLC (kappa and lambda) and albumin were determined every 30 minutes of each treatment. Chemotherapy was prescribed according to the local clinical recommendations in combination with the ongoing renal replacement therapy. Results The study included 7 patients with cast nephropathy, mean age 68±8 years. Average concentration before treatment: kappa FLC 876±727 μg/ml (norm 3.25-15.81 μg/ml), lambda FLK 84±112 μg/ml (norm 3.23-28.05 μg/ml), albumin 34±1 g/l (norm 40-50 g/l). After 2 hours of treatment, there was a decrease in kappa FLC concentration with HDF (-34±33%, p=0.01) and with Expanded HD (-31±12%, p<0.001), but not with conventional HD (-1±7, p=0.79, Fig 1). The lambda FLC concentration also decreased with HDF (-41±29%, p=0.01) and with Expanded HD (-28±22%, p=0.01), but not with conventional HD (-3±12, p=0.65, Fig 2). Albumin concentrations did not change significantly with any of the treatments. Conclusion Expanded HD, as well as high-flow HDF, helps to reduce the FLC concentration in patients with cast nephropathy without loss of albumin, which may have a positive effect on the multiple myeloma prognosis. Further studies are needed regarding possibilities of using Expanded HD in the complex therapy for patients with AKI in myeloma cast nephropathy.
Background and Aims Hydration status is an important prognostic factor in patients receiving hemodialysis (HD). An accurate hydration status assessment and determination of the euvolemia (“dry weight”, DW) target value is a difficult task and need to be objectified by instrumental methods. One of these methods is the vector analysis of multi-frequency bio-impedance spectroscopy (MBIS). The aim of the study was to assess the effect of DW correction according to the results of a vector analysis of MBIS on the blood pressure dynamics and the frequency of intra-dialysis complications. Method Total 104 patients were included in the study. The mean age was 63±11 years, mean duration of renal replacement therapy was 91±68 months. Patients were randomly (block randomization) divided into the study (SG, N=52) or control (CG, N=52) groups. In the SG, the correction of DW performed according to the results of the MBIS vector analysis using the Bodystat MultiScan 5000 analyzer (Bodystat Ltd) with specially developed correction algorithm (figure). In the CG the correction of DW was carried out only according to clinical indicators. Within 3 months before and 3 months after the initial assessment of DW the blood pressure during HD and the number of intradialytic complications were recorded in all patients. Results In the SG, DW was increased in 13 patients by an average of 1.0±0.9 kg, decreased in 26 patients (-1.1±0.7 kg) and did not change in 13 patients. In the CG, DW increased on average by 1.3±0.9 kg in 19 patients, in 27 decreased (-1.2±0.8 kg) and in 2 did not change. In patients who had a history of increased blood pressure during dialysis, in SG the frequency of hypertension episodes decreased from 3.8 to 1.1 episodes per month (p=0.02), in contrast to CG (from 2.4 up to 2.3 episodes per month, p=0.87). Also, among patients initially prone to hypertension in SG, in contrast to CG, a decrease in systolic blood pressure was observed both before the HD (from 163±16 to 143±10 mm Hg, p=0.004) and after the HD (from 151±23 to 130±15 mmHg, p=0.02). No changes in the frequency of episodes of hypotension and diastolic blood pressure during HD were observed either in the study or in the control group Conclusion Objectification of the dry weight clinical assessment of in HD patients using multifrequency bioimpedance spectroscopy with vector analysis can help to reduce the complications rate and arterial hypertension severity.
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