Dataset Information

Associations of time-dependent changes in phosphorus levels with cardiovascular diseases in patients undergoing hemodialysis: results from the Japan Dialysis Active Vitamin D (J-DAVID) randomized clinical trial.

ABSTRACT:

Background

While the risk of exceeding the standard range of phosphorus levels has been investigated, the impact of the degree of fluctuations has not been investigated.

Methods

Data were derived from the Japan Dialysis Active Vitamin D trial, a 4-year prospective, randomized study involving 976 patients without secondary hyperparathyroidism undergoing hemodialysis in Japan. Laboratory data were collected every 6 months and the primary outcome was the time to the occurrence of cardiovascular events. The effect of time-dependent changes in phosphorus levels was assessed using a time-varying Cox proportional hazards regression model.

Results

The median serum phosphorus levels at baseline and at the final observation were 4.70 mg/dl [interquartile range (IQR) 3.90-5.30] and 5.00 mg/dl (IQR 4.20-5.80), respectively. Over each 6-month period, phosphorus changes ranged from -7.1 to +6.7 mg/dl, with a median value of -0.1 to +0.3 mg/dl. During follow-up, composite cardiovascular events occurred in 103 of 964 patients. Although the P-value for the interaction between serum phosphorus level fluctuations and baseline phosphorus levels was insignificant, the following trends were observed. First, patients with relatively high initial phosphorus levels over a 6-month period showed a trend towards a higher hazard, with greater changes in the phosphorus level over the 6-month period. Second, it was suggested that oral vitamin D receptor activators could contribute to the relationship between fluctuating phosphorus levels and cardiovascular events.

Conclusions

Our results suggest the importance of maintaining stable phosphorus levels, not only in the normal range, but also without fluctuations, in the risk of cardiovascular events among patients without secondary hyperparathyroidism undergoing maintenance hemodialysis.

SUBMITTER: Koshi-Ito E

PROVIDER: S-EPMC9664581 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Associations of time-dependent changes in phosphorus levels with cardiovascular diseases in patients undergoing hemodialysis: results from the Japan Dialysis Active Vitamin D (J-DAVID) randomized clinical trial.

Koshi-Ito Eri E Inaguma Daijo D Ishii Haruka H Yuzawa Yukio Y Kabata Daijiro D Shintani Ayumi A Inaba Masaaki M Emoto Masanori M Mori Katsuhito K Morioka Tomoaki T Nakatani Shinya S Shoji Tetsuo T

Clinical kidney journal 20220803 12

<h4>Background</h4>While the risk of exceeding the standard range of phosphorus levels has been investigated, the impact of the degree of fluctuations has not been investigated.<h4>Methods</h4>Data were derived from the Japan Dialysis Active Vitamin D trial, a 4-year prospective, randomized study involving 976 patients without secondary hyperparathyroidism undergoing hemodialysis in Japan. Laboratory data were collected every 6 months and the primary outcome was the time to the occurrence of car ...[more]

PMID: 36381378

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Project description:Rationale & Objective Despite α-blockers’ use for hypertension as add-on therapy in patients treated with hemodialysis, scant information is available on their association, particularly with safety, in these patients. Study Design Prospective cohort study. Setting & Participants patients treated with hemodialysis and receiving antihypertensive agents in the Japan Dialysis Outcomes and Practice Patterns Study, phases 4-6, were analyzed. Exposure Primary exposure was the prescription of α-blocking antihypertensive agents at baseline. Outcomes Incident fractures, falls, and all-cause mortality. Analytical Approach Multivariable Cox and modified Poisson regression analysis. Results Of 5,149 patients treated with hemodialysis (mean age, 65 years; 68% men) receiving antihypertensive drugs, 717 (14%) received α-blocking agents. During a mean follow-up period of 2.0 years, 247 fractures, 525 falls, and 498 deaths occurred. Multivariable analysis showed no significant association of α-blocker use and increased risk of fractures (hazard ratio [HR], 0.92 [95% confidence interval {CI}, 0.61-1.38]), falls (HR, 0.94 [95% CI, 0.74-1.20]), or all-cause deaths (HR, 0.87 [95% CI, 0.64-1.20]) compared with α-blocker nonuse. α-Blocker use was, however, significantly associated with a decreased risk of all-cause mortality in the subgroup analysis, for example, patients who were older (HR, 0.71 [95% CI, 0.51-0.99]), were women (HR, 0.68 [95% CI, 0.48-0.95]), or reported a history of cardiovascular disease (HR, 0.67 [95% CI, 0.48-0.95]) or a predialysis blood pressure of ≥140 mm Hg (HR, 0.69 [95% CI, 0.49-0.98]). Limitations Selection bias cannot be ruled out given the prevalent user analysis. Conclusions No significant association between α-blocker use and the risk of worse safety-related outcomes was seen, indicating that clinicians may safely prescribe α-blockers to patients receiving hemodialysis who require blood pressure lowering. Plain-Language Summary α-Blockers have been generally reserved for use as add-on therapy for resistant or refractory hypertension. However, little is known about the safety of α-blockers in patients treated by hemodialysis. We analyzed 5,149 patients receiving hemodialysis in Japan who were receiving antihypertensive drugs from the Japan Dialysis Outcomes and Practice Patterns Study. The results showed no significant increase in the risk of fractures, falls, or deaths for patients using α-blockers compared with those who did not, suggesting that α-blockers may be safely prescribed for patients receiving hemodialysis who need to lower their blood pressure.

Project description:BackgroundSerum phosphorus (SP) level is closely associated with overall mortality and cardiovascular events, while the role of SP controlled duration is not fully recognized. Here, we conducted a retrospective cohort study in our department to identify the relationship of SP controlled duration with clinical outcomes in patients undergoing peritoneal dialysis (PD).MethodsPD patients in our center from January 1, 2009, to June 30, 2019, were followed up at 2-month (the first year) or 5-month (the next follow-up period) intervals, and until death, until PD withdrawal, or until June 30, 2019. Data at each follow-up point were collected from their medical records. SP levels, changed degree of SP over baseline, and SP controlled duration were analyzed with overall mortality, PD withdrawal (including death, transferred to hemodialysis, and received renal transplantation), and combined endpoint (including death, acute heart failure, cardiovascular event, and stroke).ResultsA total of 530 patients entered the analysis. Of them, 456 (86.0%) had hyperphosphatemia before dialysis, and the SP levels decreased soon after dialysis. The degree of SP change over baseline was the maximum at the 3rd month after dialysis (-31.0%), and lower degree was associated with higher overall mortality (hazard ratio [HR], 1.012; 95% CI, 1.004-1.020; p = 0.003). The median SP controlled duration was 13 (5-28) months, and longer duration was significantly associated with lower overall mortality (HR, 0.968; 95% CI, 0.956-0.981; p < 0.001). After categorization, duration more than 12 months greatly improved overall mortality with a HR of 0.197 (0.082-0.458; p < 0.001 vs. SP never controlled group) and 0.329 (0.150-0.724; p = 0.006 vs. duration <12 months group). Longer SP controlled duration also improved PD withdrawal and combined endpoint.ConclusionsIn summary, both degree and duration of SP control were tightly associated with overall mortality. We should control SP levels as early, as possible, and as long as we could.

Project description:BackgroundThe renal diet is complex and requires alterations of the diet and careful monitoring of various nutrients. Elevated serum phosphorus is common among patients undergoing hemodialysis, and it is associated with many complications. Smartphone technology could be used to support both dietitians and patients by providing a source of accessible and reliable information.ObjectiveThe aim of this pilot is to assess the potential efficacy of an intervention using the educational and self-monitoring mobile app KELA.AE on the phosphorous management in hemodialysis patients. Results will be used to improve both the app and a planned, rigorous large-scale trial intended to assess app efficacy.MethodsThis is a prospective pilot study performed at the hemodialysis unit of Al Qassimi Hospital (Emirate of Sharjah, United Arab Emirates). All patients were assessed for eligibility and, based on inclusion criteria, considered for enrollment. Participants met with a dietitian once a week and used the mobile app regularly for 2 weeks. Outcomes (knowledge, self-reported nonadherence, dietary intake, anthropometry, and biochemical data) were measured. This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist for reporting pilot or feasibility trials.ResultsOf 26 subjects, 23 successfully completed the pilot. Patient dietary knowledge about phosphorous management improved from 51.4% (SD 13.9) to 68.1% (SD 13.3) after intervention with a large effect size (d=1.22, 95% CI 0.59 to 1.85). Dietary protein intake increased from a mean of 0.9 g/kg (SD 0.3) per day to a mean of 1.3 g/kg (SD 0.5) per day with a large effect size (d=1.07, 95% CI 0.45 to 1.69). Phosphorus to protein ratio dropped from a mean of 18.4 mg/g protein to 13.5 mg/g protein with a large effect size (d=0.83, 95% CI 0.22 to 1.43). There was no evidence of change in phosphorous intake, self-reported nonadherence, and serum phosphorus.ConclusionsThe findings of this prospective pilot reveal the potential efficacy of a smartphone app as a supportive nutrition education tool for phosphorus management in patients undergoing hemodialysis. This pilot study showed that the KELA.AE app has the potential to improve knowledge and dietary choices. A rigorous randomized controlled trial should be performed to evaluate the efficacy, assessing app use of a long-term intervention.

Dataset Information

Associations of time-dependent changes in phosphorus levels with cardiovascular diseases in patients undergoing hemodialysis: results from the Japan Dialysis Active Vitamin D (J-DAVID) randomized clinical trial.

Background

Methods

Results

Conclusions

Publications

Associations of time-dependent changes in phosphorus levels with cardiovascular diseases in patients undergoing hemodialysis: results from the Japan Dialysis Active Vitamin D (J-DAVID) randomized clinical trial.

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