Wendy L. St. Peter

Excerpts From the US Renal Data System 2009 Annual Data Report

This 21st US Renal Data System Annual Data Report covers data through 2007, and again includes a section on chronic kidney disease (CKD) in the United States. Using NHANES and employer group health plan data, we estimate the relationship between kidney disease markers and mortality risk and the likelihood of blood pressure and lipid control by CKD stage; illustrate use of the new ICD-9-CM CKD diagnosis codes; and report on morbidity, mortality, care and costs during the transition to ESRD. New chapters address CKD patient care, the transition to ESRD, and acute kidney injury. In 2007, 111,000 patients started end-stage renal disease (ESRD) therapy, and the prevalent population reached 527,283 (including 368,544 dialysis patients); 17,513 transplants were performed, and 158,739 patients had a functioning graft at year’s end. Program expenditures reached

United States Renal Data System 2008 Annual Data Report Abstract

35.3 billion, with

A Comparison of Sevelamer and Calcium-Based Phosphate Binders on Mortality, Hospitalization, and Morbidity in Hemodialysis: A Secondary Analysis of the Dialysis Clinical Outcomes Revisited (DCOR) Randomized Trial Using Claims Data

23.9 billion from Medicare (accounting for 5.8% of total Medicare expenditures). The incident rate fell 2.1%, to 354 per million. Fistula use in prevalent patients declined 2.6 percent; catheter use continues to be a concern. The percentage of patients with hemoglobin levels above 13 g/dl has fallen since 2006, but levels in the incident population frequently exceed 12. First-year mortality and morbidity among hemodialysis patients—particularly the increasing rate of hospitalizations due to infections—continue to be major concerns, and pediatric patient survival has not improved. The public health impact of kidney disease is larger than previously appreciated, and early detection, education, intervention, and risk factor control need to address the heavy burden of cardiovascular disease and adverse events in this vulnerable population.

Cinacalcet hydrochloride treatment significantly improves all-cause and cardiovascular survival in a large cohort of hemodialysis patients.

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Comparative evaluation of the Cockcroft-Gault Equation and the Modification of Diet in Renal Disease (MDRD) study equation for drug dosing: an opinion of the Nephrology Practice and Research Network of the American College of Clinical Pharmacy.

BACKGROUND The Dialysis Clinical Outcomes Revisited (DCOR) trial, a large, randomized, multicenter, open-label study, compared effects of sevelamer with calcium-based phosphate binders on mortality and hospitalization in hemodialysis patients. Many patients were lost to follow-up, precluding intent-to-treat analysis by using prospective data collection. STUDY DESIGN Preplanned secondary analysis, intent-to-treat design for all outcomes, using Centers for Medicare & Medicaid Services (CMS) data. SETTING & PARTICIPANTS Participants were 18 years or older and on hemodialysis therapy for more than 3 months, with Medicare as primary payor. The trial was completed at the end of 2004. INTERVENTION Sevelamer, calcium-based phosphate binders. OUTCOMES Mortality, morbidity, and hospitalization end points. MEASUREMENTS DCOR subjects were linked to the CMS End-Stage Renal Disease database. Outcomes were evaluated through the CMS End-Stage Renal Disease enrollment and claims database; baseline characteristics and comorbid conditions were evaluated using CMS and case-report data. RESULTS Groups were well balanced except for a greater percentage of calcium-group patients with atherosclerotic heart disease. Analyses were adjusted by using 10 baseline characteristics. All-cause (17.7 versus 17.4 deaths/100 patient-years; P = 0.8 unadjusted; P = 0.9 adjusted) and cardiovascular mortality (9.0 versus 8.2 deaths/100 patient-years; P = 0.3 unadjusted; P = 0.4 adjusted) did not differ significantly between treatment groups. First hospitalization, cause-specific multiple hospitalizations, first morbidity, and multiple morbidity rates also did not differ significantly. Multiple all-cause hospitalization rate (1.7 versus 1.9 admissions/patient-year; P = 0.03 unadjusted; P = 0.02 adjusted) and hospital days (12.3 versus 13.9 days/patient-year; P = 0.05 unadjusted; P = 0.03 adjusted) were lower in the sevelamer group. LIMITATIONS Outcome parameters and cardiovascular comorbidity assessments were derived from Medicare claims data; only subjects with Medicare-as-primary-payor status were included in hospitalization and morbidity analyses. CONCLUSIONS In this secondary analysis, treatment with sevelamer versus calcium-based binders did not affect overall mortality (primary outcome), cause-specific mortality, morbidity, or first or cause-specific hospitalization (secondary outcomes), but there was evidence for a beneficial effect on multiple all-cause hospitalizations and hospital days (secondary outcomes).

Association Between Copayment and Adherence to Statin Treatment Initiated After Coronary Heart Disease Hospitalization : A Longitudinal, Retrospective, Cohort Study

Secondary hyperparathyroidism (SHPT) affects a significant number of hemodialysis patients, and metabolic disturbances associated with it may contribute to their high mortality rate. As patients with lower serum calcium, phosphorus, and parathyroid hormone are reported to have improved survival, we tested whether prescription of the calcimimetic cinacalcet to hemodialysis patients with SHPT improved their survival. We prospectively collected data on hemodialysis patients from a large provider beginning in 2004, a time coincident with the commercial availability of cinacalcet hydrochloride. This information was merged with data in the United States Renal Data System to determine all-cause and cardiovascular mortality. Patients included in the study received intravenous (i.v.) vitamin D therapy (a surrogate for the diagnosis of SHPT). Of 19,186 patients, 5976 received cinacalcet and all were followed from November 2004 for up to 26 months. Unadjusted and adjusted time-dependent Cox proportional hazards modeling found that all-cause and cardiovascular mortality rates were significantly lower for those treated with cinacalcet than for those without calcimimetic. Hence, this observational study found a significant survival benefit associated with cinacalcet prescription in patients receiving i.v. vitamin D. Definitive proof, however, of a survival advantage awaits the performance of randomized clinical trials.

Clinical Pharmacokinetics of Antibiotics in Patients with Impaired Renal Function

Accurate assessment of kidney function is an important component of determining appropriate drug dosing regimens. Nearly all manufacturer‐recommended dosage adjustments are based on creatinine clearance ranges derived from clinical pharmacokinetic studies performed during the drug development process. The Cockcroft‐Gault (CG) equation provides an estimate of creatinine clearance and is the equation most commonly used to determine drug dosages in patients with impaired kidney function. The Modification of Diet in Renal Disease (MDRD) study equation has also been proposed for this purpose. Published studies report that drug dosages determined by the two equations do not agree in 1 0–40% of cases. However, interpretation and comparison of these studies are complicated by the variable creatinine methods used for calculating CG and MDRD estimates, the patient populations studied, and a lack of outcomes data demonstrating the clinical significance of dosing discrepancies. Moreover, the impact of reporting standardized serum creatinine values on the accuracy of the CG equation and corresponding drug dosing regimens have been questioned. Currently, no prospective pharmacokinetic studies have been conducted with use of the MDRD equation to generate dosing recommendations, and limited data are available to support its use in some patient populations representing demographic extremes. Collectively, these issues have resulted in considerable confusion among clinicians and have fueled a healthy debate on whether or not to use the MDRD equation to determine drug dosages. Each of these issues is reviewed, and a proposed algorithm for using creatinine‐based kidney function assessments in drug dosing is provided. Knowledge of the advantages, limitations, and clinical role of each equation will facilitate their safe and effective use in drug dosing.

Trends in Parathyroidectomy Rates in US Hemodialysis Patients From 1992 to 2007

BACKGROUND Despite substantial evidence supporting the effectiveness of statin treatment, when administered regularly for the secondary prevention of coronary heart disease (CHD), many patients are not adherent. OBJECTIVE The objective of this study was to examine the relationship between copayment and adherence to statin treatment among patients who initiated statin treatment after discharge from a CHD hospitalization. METHODS Databases containing inpatient admission, outpatient, enrollment, and pharmacy claims from 1999 to 2003 were utilized for this study. The sample consisted of adults who initiated statin treatment after hospitalization directly related to CHD. Adherence to statins was measured by medication possession ratio (MPR), a surrogate marker of adherence calculated as a percentage of days with statins on hand during a 1-year observation period. The relationship between copayment and adherence to statin treatment was examined using multivariate logistic regression models. Demographic and clinical characteristics were selected as control variables based on modified versions of the Andersen health services utilization model as well as previous study findings. RESULTS A total of 5,548 patients met the study entry criteria and were included in the analysis. Of this number, 3,404 patients (61.4%) had an MPR of >or=80% and were considered adherent to statins. Compared with those who had a copayment or=USD20 were significantly less likely to be adherent to statins (odds ratio, 0.42; 95% CI, 0.36-0.49). Other relevant factors significantly associated with low adherence were younger age (P < 0.001), female sex (P < 0.001), absence of dyslipidemia diagnosis (P < 0.001), presence of depression (P = 0.010), and concomitant use of nonstatin lipid-lowering drugs (P < 0.001). CONCLUSIONS Adherence during the 1-year period after statin initiation among CHD hospitalized patients was suboptimal, with more than one third of the patients not adherent to statin treatment. High prescription copayment appeared to be a significant barrier to statin adherence, even after adjusting for demographic and clinical variables.

Cinacalcet Use Patterns and Effect on Laboratory Values and Other Medications in a Large Dialysis Organization, 2004 through 2006

SummaryMany antibiotics are eliminated renally and dosage adjustments are commonly made in patients with renal insufficiency. This is a critical review of antibiotic pharmacokinetics in patients with various degrees of renal function. Detailed information regarding pharmacokinetic alterations with specific antibiotics or antibiotic classes has been compiled and tabulated. From pharmacokinetic evidence, recommendations for dosage adjustments of antibiotics are supplied. The criteria used for assigning rating levels to specific pharmacokinetic articles as well as the grading system for dosage adjustments are outlined. In addition, a basic review of pharmacokinetic alterations in renal failure and factors affecting the removal of drugs by haemodialysis is included.

Trends in Hip Fracture Rates in US Hemodialysis Patients, 1993-2010

BACKGROUND Parathyroidectomy rates in hemodialysis patients increased from 1992 to 2002, when medication choices to manage secondary hyperparathyroidism expanded. STUDY DESIGN Retrospective follow-up registry study. SETTING & PARTICIPANTS We evaluated annual cohorts of point-prevalent US hemodialysis patients with Medicare as primary payer for 1992-2007 (n = 1,063,258 for 1992-1999; 757,207 for 2000-2003; 902,119 for 2004-2007). PREDICTOR Comorbid conditions, vitamin D use, previous kidney transplant, and parathyroid hormone testing were assessed in the previous year. Available bone and mineral disorder treatment patterns were evaluated. OUTCOMES We examined incidence rate trends and patient characteristics through 2007 to estimate the association between parathyroidectomy and patient factors. Follow-up was from January 1 of each study year to the earliest in the same year of parathyroidectomy, death, or December 31. MEASUREMENTS We used χ(2) analysis to compare patient characteristics in 3 time frames. Unadjusted and adjusted parathyroidectomy rates were calculated. Cox regression was used to test the association of parathyroidectomy and covariates. RESULTS Adjusted parathyroidectomy rates increased from 1998 (7.0/1,000 patient-years; 1,045 events), peaked in 2002 (12.8/1,000 patient-years; 2,229 events), decreased through 2005 (5.4/1,000 patient-years; 1,078 events), and increased in 2006 (8.6/1,000 patient-years; 1,743 events) and 2007 (8.8/1,000 patient-years; 1,832 events). Vitamin D use, virtually undetectable in 1991, subsequently steadily increased; >80% of patients received vitamin D in 2006. LIMITATIONS The study was not designed to provide causal explanations for observed changes; oral medication use trend data were limited to one large dialysis provider and may not reflect use patterns in all dialysis facilities; because Medicare is not the primary payer for all US hemodialysis patients, results do not describe the entire US hemodialysis population; parathyroid hormone values are lacking in the database. CONCLUSIONS Adjusted parathyroidectomy rates varied substantially from 1992 through 2007. Rates were highest in 1994 and 2002 and lowest in 1998 and 2005, likely influenced by changing medication use patterns and guideline publication.