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Comparative effectiveness of calcium acetate and sevelamer on clinical outcomes in elderly hemodialysis patients enrolled in Medicare part D.

ABSTRACT: BACKGROUND:Phosphate binders are an important therapeutic option for managing hyperphosphatemia in hemodialysis patients. Whether sevelamer confers a survival advantage over calcium acetate is unclear. STUDY DESIGN:Observational cohort study using US Renal Data System (USRDS) data linked to Medicare Part D prescription drug data. SETTING & PARTICIPANTS:Medicare-enrolled elderly incident hemodialysis patients initiating calcium acetate or sevelamer therapy between July 1, 2006, and March 31, 2011. PREDICTOR:Prescription for sevelamer (hydrochloride or carbonate) or calcium acetate. OUTCOMES & MEASUREMENTS:All-cause and cardiovascular-related mortality, hospital admissions and hospital days assessed from Medicare Parts A, B, and D claims and other USRDS data. RESULTS:The sevelamer and calcium-acetate groups included 16,916 and 18,335 patients, respectively. After multivariable adjustment, all-cause (21.9 vs 21.8 deaths/100 patient-years; adjusted HR, 0.97; 95% CI, 0.94-1.03) and cardiovascular (8.7 vs 8.6 deaths/100 patient-years; HR, 0.99; 95% CI, 0.93-1.04) mortality did not differ significantly between the sevelamer and calcium-acetate (referent) groups. Mortality results in propensity score-matched cohorts showed significantly lower risk of death in sevelamer- than in calcium-acetate-treated patients (HR, 0.94; 95% CI, 0.91-0.98). Mortality results from additional analyses including only patients with low-income subsidy status were consistent with results from analyses including patients with and without low-income subsidy status. There were no significant differences between the sevelamer and calcium-acetate groups for all-cause and cardiovascular-related first hospitalization, multiple hospitalizations, and hospital days. LIMITATIONS:Results may not be applicable to younger patients; information about laboratory data and over-the-counter calcium-containing binders was lacking. CONCLUSIONS:Relative to treatment with calcium acetate, treatment with sevelamer was associated with similar or slightly lower risk of death and similar risk of hospitalization in elderly incident hemodialysis patients.

SUBMITTER: Yusuf AA

PROVIDER: S-EPMC4069228 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Comparative effectiveness of calcium acetate and sevelamer on clinical outcomes in elderly hemodialysis patients enrolled in Medicare part D.

Yusuf Akeem A AA Weinhandl Eric D ED St Peter Wendy L WL

American journal of kidney diseases : the official journal of the National Kidney Foundation 20131231 1

<h4>Background</h4>Phosphate binders are an important therapeutic option for managing hyperphosphatemia in hemodialysis patients. Whether sevelamer confers a survival advantage over calcium acetate is unclear.<h4>Study design</h4>Observational cohort study using US Renal Data System (USRDS) data linked to Medicare Part D prescription drug data.<h4>Setting & participants</h4>Medicare-enrolled elderly incident hemodialysis patients initiating calcium acetate or sevelamer therapy between July 1, 20 ...[more]

PMID: 24387795

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Project description:BackgroundHigh levels of serum phosphorus both at baseline and during follow-up are associated with increased mortality in dialysis patients, and administration of phosphate binders was independently associated with improved survival among hemodialysis population. Calcium-based phosphate binders are the most commonly used phosphate binders in developing countries for their relatively low costs.ObjectivesTo compare the efficacy and safety between calcium carbonate and calcium acetate in the treatment of hyperphosphatemia in hemodialysis patients.MethodsPubMed, EMBASE, Cochrane Library, Google scholar and Chinese databases (Wanfang, Weipu, National Knowledge Infrastructure of China) were searched for relevant studies published before March 2014. Reference lists of nephrology textbooks and review articles were checked. A meta-analysis of randomized controlled trials (RCTs) and quasi-RCTs that assessed the effects and adverse events of calcium acetate and calcium carbonate in adult patients with MHD was performed using Review Manager 5.0.ResultsA total of ten studies (625 participants) were included in this meta-analysis. There was insufficient data in all-cause mortality and cardiovascular events for meta-analysis. Compared with calcium carbonate group, the serum phosphorus was significantly lower in calcium acetate group after4 weeks' administration (MD -0.15 mmol/L, 95% CI -0.28 to -0.01) and after 8 weeks' administration (MD -0.25 mmol/L, 95% CI -0.40 to -0.11). There was no difference in serum calcium levels or the incidence of hypercalcemia between two groups at 4 weeks and 8 weeks. No statistical difference was found in parathyroid hormone (PTH) levels or serum calcium by phosphorus (Ca x P) product. There was significantly higher risk of intolerance with calcium acetate treatment (RR 3.46, 95% CI 1.48 to 8.26).ConclusionsFor hyperphosphatemia treatment, calcium acetate showed better efficacy and with a higher incidence of intolerance compared with calcium carbonate. There are insufficient data to establish the comparative superiority of the two calcium-based phosphate binders on all-cause mortality and cardiovascular end-points in hemodialysis patients.

Project description:BackgroundCoronary stenting in patients on dialysis has increased by nearly 50% over the past decade, despite heightened risks of associated stent thrombosis and bleeding relative to the general population. We examined clopidogrel, prasugrel or ticlopidine use after percutaneous coronary intervention (PCI) with stenting in patients on dialysis. We conducted 3-, 6-, and 12-month landmark analyses to test the hypothesis that thienopyridine discontinuation prior to those time points would be associated with higher risks of death, myocardial infarction, or repeat revascularization, and a lower risk of major bleeding episodes compared with continued thienopyridine use.Methods and resultsUsing the US Renal Data System, we identified 8458 patients on dialysis with Medicare Parts A+B+D undergoing PCI with stenting between July 2007 and December 2010. Ninety-nine percent of all thienopyridine prescriptions were for clopidogrel. At 3 months, 82% of patients who received drug-eluting stents (DES) had evidence of thienopyridine use. These proportions fell to 62% and 40% at 6 and 12 months, respectively. In patients who received a bare-metal stent (BMS), 70%, 34%, and 26% of patients had evidence of thienopyridine use at 3, 6, and 12 months, respectively. In patients who received a DES, there was a suggestion of higher risks of death or myocardial infarction associated with thienopyridine discontinuation in the 3-, 6-, and 12-months landmark analyses, but no higher risk of major bleeding episodes. In patients who received a BMS, there were no differences in death or cardiovascular events, and possibly lower risk of major bleeding with thienopyridine discontinuation in the 3- and 6-month landmark analyses.ConclusionsThe majority of patients on dialysis who undergo PCI discontinue thienopyridines before 1 year regardless of stent type. While not definitive, these data suggest that longer-term thienopyridine use may be of benefit to patients on dialysis who undergo PCI with DES.

Project description:ImportancePrescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions.ObjectiveTo characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending.Design, setting, and participantsIn this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020.Main outcomes and measuresThe presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry.ResultsMedicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements.Conclusions and relevanceIn this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.

Dataset Information

Comparative effectiveness of calcium acetate and sevelamer on clinical outcomes in elderly hemodialysis patients enrolled in Medicare part D.

Publications

Comparative effectiveness of calcium acetate and sevelamer on clinical outcomes in elderly hemodialysis patients enrolled in Medicare part D.

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