Dataset Information

Effects of calcium-containing phosphate binders on cardiovascular events and mortality in predialysis CKD stage 5 patients.

ABSTRACT: BACKGROUND:Hyperphosphatemia and calcium load were associated with vascular calcification. The role of calcium-containing phosphate binders (CCPBs) use as important determinants of death and cardiovascular events in predialysis hyperphosphatemic chronic kidney disease (CKD) patients remain unclear due to the absence of evidence for reduced mortality with CCPB use compared with placebo. We aimed to investigate the effect of using CCPBs or nonuse in all-cause mortality rates and cardiovascular events in CKD stage 5 patients between 2000 and 2005 in the Taiwanese National Health Insurance Research Database. METHODS:Patients with known coronary heart disease and those who had undergone dialysis or renal transplantation were excluded. The CCPB users were matched with nonusers by the propensity score model. Multivariable Cox proportional hazards model was used to estimate hazard ratios (HRs) of all-cause mortality and cardiovascular events. RESULTS:During a mean follow-up of 4.58 years, 879 CCPB users were matched with 3516 nonusers. CCPB use was an independent risk factor for cardiovascular events [adjusted hazard ratio (HR) 1.583, 95% confidence interval (CI) 1.393-1.799]. The increased cardiovascular risk was dose-dependent and consistent across all subgroup analyses. Compared with no use, CCPB use was associated with no significant all-cause mortality risk (1.74 vs. 1.75 events per 100 person-years, adjusted HR 0.964, 95% CI 0.692-1.310). CONCLUSIONS:CCPB use in CKD stage 5 patients was associated with a significantly increased cardiovascular event risk compared with the nonusers, whereas the all-cause mortality risk was similar between the two groups. Whether these relationships are causal require further randomized controlled trials.

SUBMITTER: Tsai PH

PROVIDER: S-EPMC7598463 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effects of calcium-containing phosphate binders on cardiovascular events and mortality in predialysis CKD stage 5 patients.

Tsai Ping-Huang PH Chung Chi-Hsiang CH Chien Wu-Chien WC Chu Pauling P

PloS one 20201030 10

<h4>Background</h4>Hyperphosphatemia and calcium load were associated with vascular calcification. The role of calcium-containing phosphate binders (CCPBs) use as important determinants of death and cardiovascular events in predialysis hyperphosphatemic chronic kidney disease (CKD) patients remain unclear due to the absence of evidence for reduced mortality with CCPB use compared with placebo. We aimed to investigate the effect of using CCPBs or nonuse in all-cause mortality rates and cardiovasc ...[more]

PMID: 33125428

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Project description:ImportanceGuidelines restricting use of calcium-based phosphate binders in all patients with end-stage renal disease owing to their potential contribution to increased cardiovascular risk shifted prescribing from calcium acetate toward the costlier sevelamer carbonate products.ObjectiveTo compare cardiovascular events and mortality between patients with end-stage renal disease (ESRD) undergoing hemodialysis receiving sevelamer vs calcium acetate in real-world practice.Design, setting, and participantsAn observational cohort study was conducted using the United States Renal Data System linked to Medicare claims data (May 1, 2012, to December 31, 2013). Data analysis was performed from October 2017 to September 2018. Participants included patients 65 years or older with ESRD within 180 days after starting hemodialysis (sevelamer, 2647; calcium acetate, 2074).ExposuresNew use of sevelamer (calcium-free phosphate binder) vs calcium acetate (calcium-based phosphate binder).Main outcomes and measuresHazard ratios (HRs) with 95% CIs were estimated for fatal or nonfatal cardiovascular events (myocardial infarction or ischemic stroke: primary outcome) and all-cause mortality (secondary outcome) using Cox proportional hazards regression with fine stratification on the propensity score to control for potential confounders, including phosphorus and calcium levels.ResultsAfter propensity score weighting, 2639 patients initiating sevelamer treatment (1184 men [44.9%]; mean [SD] age, 75.6 [6.9] years) and 2065 patients initiating calcium acetate treatment (930 men [45.0%]; mean [SD] age, 75.5 [7.1] years) were included in the analysis. Crude incidence rates (IRs) for cardiovascular events of 458 per 1000 person-years for sevelamer and 464 per 1000 person-years for calcium acetate were observed. After propensity score fine-stratification weighting, HRs of 0.96 (95% CI, 0.84-1.10) for cardiovascular events were observed. Results were consistent within subgroups of age (<75 y: primary outcome, HR, 1.02; 95% CI, 0.85-1.24; vs ≥75 years: primary outcome, HR, 0.83; 95% CI, 0.69-1.01) and sex (primary outcome in men: HR, 1.02; 95% CI, 0.83-1.26).Conclusions and relevanceThe results of the study do not suggest increased cardiovascular safety of sevelamer in the routine clinical practice of patients with ESRD compared with calcium acetate; this study's findings suggest that well-designed, long-term, randomized clinical trials are needed.

Project description:Medication nonadherence is a known risk factor for adverse outcomes in the general population. However, little is known about the association of predialysis medication adherence among patients with advanced chronic kidney disease and mortality following their transition to dialysis.Observational study.32,348 US veterans who transitioned to dialysis during 2007 to 2011.Adherence to treatment with cardiovascular drugs, ascertained from pharmacy database records using proportion of days covered (PDC) and persistence during the predialysis year.Post-dialysis therapy initiation all-cause and cardiovascular mortality, using Cox models with adjustment for confounders.Mean age of the cohort was 72±11 (SD) years; 96% were men, 74% were white, 23% were African American, and 69% had diabetes. During a median follow-up of 23 (IQR, 9-36) months, 18,608 patients died. Among patients with PDC>80%, there were 14,006 deaths (mortality rate, 283 [95% CI, 278-288]/1,000 patient-years]); among patients with PDC>60% to 80%, there were 3,882 deaths (mortality rate, 294 [95% CI, 285-304]/1,000 patient-years); among patients with PDC?60%, there were 720 deaths (mortality rate, 291 [95% CI, 271-313]/1,000 patient-years). Compared with patients with PDC>80%, the adjusted HR for post-dialysis therapy initiation all-cause mortality for patients with PDC>60% to 80% was 1.12 (95% CI, 1.08-1.16), and for patients with PDC?60% was 1.21 (95% CI, 1.11-1.30). In addition, compared with patients showing medication persistence, adjusted HR risk for post-dialysis therapy initiation all-cause mortality for patients with nonpersistence was 1.11 (95% CI, 1.05-1.16). A similar trend was detected for cardiovascular mortality and in subgroup analyses.Large number of missing values; results may not be generalizable to women or the general US population.Predialysis cardiovascular medication nonadherence is an independent risk factor for postdialysis mortality in patients with advanced chronic kidney disease transitioning to dialysis therapy. Further studies are needed to assess whether interventions targeting adherence improve survival after dialysis therapy initiation.

Project description:RATIONALE & OBJECTIVE:Inflammation, cardiac remodeling, and fibrosis may explain in part the excess risk for cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Growth differentiation factor 15 (GDF-15), galectin 3 (Gal-3), and soluble ST2 (sST2) are possible biomarkers of these pathways in patients with CKD. STUDY DESIGN:Observational cohort study. SETTING & PARTICIPANTS:Individuals with CKD enrolled in either of 2 multicenter CKD cohort studies: the Seattle Kidney Study or C-PROBE (Clinical Phenotyping and Resource Biobank Study). EXPOSURES:Circulating GDF-15, Gal-3, and sST2 measured at baseline. OUTCOMES:Primary outcome was all-cause mortality. Secondary outcomes included hospitalization for physician-adjudicated heart failure and the atherosclerotic CVD events of myocardial infarction and cerebrovascular accident. ANALYTIC APPROACH:Cox proportional hazards models used to test the association of each biomarker with each outcome, adjusting for demographics, CVD risk factors, and kidney function. RESULTS:Among 883 participants, mean estimated glomerular filtration rate was 49±19mL/min/1.73m2. Higher GDF-15 (adjusted HR [aHR] per 1-SD higher, 1.87; 95% CI, 1.53-2.29), Gal-3 (aHR per 1-SD higher, 1.51; 95% CI, 1.36-1.78), and sST2 (aHR per 1-SD higher, 1.36; 95% CI, 1.17-1.58) concentrations were significantly associated with mortality. Only GDF-15 level was also associated with heart failure events (HR per 1-SD higher, 1.56; 95% CI, 1.12-2.16). There were no detectable associations between GDF-15, Gal-3, or sST2 concentrations and atherosclerotic CVD events. LIMITATIONS:Event rates for heart failure and atherosclerotic CVD were low. CONCLUSIONS:Adults with CKD and higher circulating GDF-15, Gal-3, and sST2 concentrations experienced greater mortality. Elevated GDF-15 concentration was also associated with an increased rate of heart failure. Further work is needed to elucidate the mechanisms linking these circulating biomarkers with CVD in patients with CKD.

Project description:Rationale & objectiveElevated levels of deoxycholic acid (DCA) are associated with adverse outcomes and may contribute to vascular calcification in patients with chronic kidney disease (CKD). We tested the hypothesis that elevated levels of DCA were associated with increased risks of cardiovascular disease, CKD progression, and death in patients with CKD.Study designProspective observational cohort study.Setting & participantsWe included 3,147 Chronic Renal Insufficiency Cohort study participants who had fasting DCA levels. The average age was 59 ± 11 years, 45.3% were women, 40.6% were African American, and the mean estimated glomerular filtration rate was 42.5 ± 16.0 mL/min/1.73 m2.PredictorFasting DCA levels in Chronic Renal Insufficiency Cohort study participants.OutcomesRisks of atherosclerotic and heart failure events, end-stage kidney disease (ESKD), and all-cause mortality.Analytical approachWe used Tobit regression to identify predictors of DCA levels. We used Cox regression to examine the association between fasting DCA levels and clinical outcomes.ResultsThe strongest predictors of elevated DCA levels in adjusted models were increased age and nonuse of statins. The associations between log-transformed DCA levels and clinical outcomes were nonlinear. After adjustment, DCA levels above the median were independently associated with higher risks of ESKD (HR, 2.67; 95% CI, 1.51-4.74) and all-cause mortality (HR, 2.13; 95% CI, 1.25-3.64). DCA levels above the median were not associated with atherosclerotic and heart failure events, and DCA levels below the median were not associated with clinical outcomes.LimitationsWe were unable to measure DCA longitudinally or in urinary or fecal samples, and we were unable to measure other bile acids. We also could not measure many factors that affect DCA levels.ConclusionsIn 3,147 participants with CKD stages 2-4, DCA levels above the median were independently associated with ESKD and all-cause mortality.

Dataset Information

Effects of calcium-containing phosphate binders on cardiovascular events and mortality in predialysis CKD stage 5 patients.

Publications

Effects of calcium-containing phosphate binders on cardiovascular events and mortality in predialysis CKD stage 5 patients.

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