Strategies to Guide Preemptive Waitlisting and Equity in Waittime Accrual by Race/Ethnicity.

BACKGROUND: Use of eGFR to determine preemptive waitlisting eligibility may contribute to racial/ethnic disparities in access to waitlisting, which can only occur when the eGFR falls to ≤20 ml/min per 1.73 m 2 . Use of an alternative risk-based strategy for waitlisting may reduce these inequities ( e.g. , a kidney failure risk equation [KFRE] estimated 2-year risk of kidney failure) rather than the standard eGFR threshold for determining waitlist eligibility. Our objective was to model the amount of preemptive waittime that could be accrued by race and ethnicity, applying two different strategies to determine waitlist eligibility. METHODS: Using electronic health record data, linear mixed models were used to compare racial/ethnic differences in preemptive waittime that could be accrued using two strategies: estimating the time between an eGFR ≤20 and 5 ml/min per 1.73 m 2 versus time between a 25% 2-year predicted risk of kidney failure (using the KFRE, which incorporates age, sex, albuminuria, and eGFR to provide kidney failure risk estimation) and eGFR of 5 ml/min per 1.73 m 2 . RESULTS: Among 1290 adults with CKD stages 4-5, using the Chronic Kidney Disease Epidemiology Collaboration equation yielded shorter preemptive waittime between an eGFR of 20 and 5 ml/min per 1.73 m 2 in Black (-6.8 months; 95% confidence interval [CI], -11.7 to -1.9), Hispanic (-10.2 months; -15.3 to -5.1), and Asian/Pacific Islander (-10.3 months; 95% CI, -15.3 to -5.4) patients compared with non-Hispanic White patients. Use of a KFRE threshold to determine waittime yielded smaller differences by race and ethnicity than observed when using a single eGFR threshold, with shorter time still noted for Black (-2.5 months; 95% CI, -7.8 to 2.7), Hispanic (-4.8 months; 95% CI, -10.3 to 0.6), and Asian/Pacific Islander (-5.4 months; -10.7 to -0.1) individuals compared with non-Hispanic White individuals, but findings only met statistical significance criteria in Asian/Pacific Islander individuals. When we compared potential waittime availability using a KFRE versus eGFR threshold, use of the KFRE yielded more equity in waittime for Black ( P = 0.02), Hispanic ( P = 0.002), and Asian/Pacific Islander ( P = 0.002) patients. CONCLUSIONS: Use of a risk-based strategy was associated with greater racial equity in waittime accrual compared with use of a standard single eGFR threshold to determine eligibility for preemptive waitlisting.

Healthcare Resource Utilization and Costs of Rivaroxaban Versus Warfarin Among Non-valvular Atrial Fibrillation (NVAF) Patients with Diabetes in a US Population.

INTRODUCTION: The healthcare resource utilization (HRU) and costs of oral anticoagulant-naïve patients with non-valvular atrial fibrillation (NVAF) and diabetes initiated on rivaroxaban or warfarin in the United States (US) has not been previously evaluated. METHODS: This retrospective study used data from the Optum's de-identified Clinformatics® Data Mart Database (1 January, 2012 to 30 September, 2021) to evaluate the HRU and costs of adult patients with NVAF and diabetes newly initiated on rivaroxaban or warfarin (on or after January 2013). Inverse probability of treatment weighting (IPTW) was used to adjust for confounding between cohorts. HRU and costs (USD 2021) were assessed per patient-year (PPY) post-treatment initiation. Weighted cohorts were compared using rate ratios (RR) from Poisson regression models, odds ratios (OR) from logistic regression models, and cost differences; 95% confidence intervals (CI) and p values were generated using non-parametric bootstrap procedures. RESULTS: After IPTW, 17,881 and 19,274 patients initiated on rivaroxaban and warfarin were included, respectively (mean age: 73 years; 40% female). During 12 months of follow-up, the rivaroxaban cohort had lower all-cause HRU PPY across all components, including lower rates of inpatient stays (RR: 0.84, 95% CI 0.81, 0.88), outpatient visits (RR: 0.67, 95% CI 0.66, 0.68), and 30 day hospital readmission (OR: 0.75, 95% CI 0.66, 0.83; all p < 0.001) compared to the warfarin cohort. Moreover, rivaroxaban was associated with medical cost savings PPY (mean cost difference: - $9306, 95% CI - $11,769, - $6607), which compensated for higher pharmacy costs relative to warfarin (mean cost difference: $5518, 95% CI $5193, $5839), resulting in significantly lower all-cause total healthcare costs for rivaroxaban versus warfarin (mean cost difference: - $3788, 95% CI - $6258, - $1035; all p < 0.001). CONCLUSION: Among NVAF patients with diabetes in a real-world US setting, rivaroxaban was associated with lower healthcare costs compared to warfarin.

Prevalence and management of hyperkalemia in chronic kidney disease and heart failure patients in the Gulf Cooperation Council (GCC).

Hyperkalemia is a frequent complication in patients with chronic kidney disease (CKD) or heart failure (HF) and associated with neuromuscular manifestations, changes in the electrocardiogram, and increased risk of mortality. While data on the prevalence and management of hyperkalemia in the gulf region are scarce, risk factors such as preference for potassium-rich foods (e.g., dates and dried fruits/vegetables), periods of intense fasting (e.g., Ramadan), and diabetes (an ancestor of CKD and HF) are common. Therefore, a panel of nephrologists and cardiologists from countries of the Gulf Cooperation Council (GCC) convened to collate and review available data on the prevalence, regional drivers, and current practice in the management of hyperkalemia in the region. Eventually, this review provides consensus recommendations on a balanced utilization of dietary and pharmacological options including new potassium binders for achieving and sustainably maintaining desirable serum potassium levels in countries of the GCC region. Alignment with regional habits and practice was a key aspect to facilitate the uptake of the recommendations into physicians' practice and patients' lives.

Potential Role and Limitations of Estimated Glomerular Filtration Rate Slope Assessment in Cardiovascular Trials: A Review.

Importance: Cardiovascular trials have traditionally been underpowered to assess advanced chronic kidney disease (CKD) outcomes, and when included as a secondary end point, trials have used progression of CKD as incidence of some variation of a composite of end-stage kidney disease (ESKD) outcomes. Such outcomes are infrequent or occur late in cardiovascular outcome trials, which highlights the need for alternate markers for assessing the impact of interventions on kidney function at an earlier stage of the disease and, from the prevention perspective, more relevant stage of the disease. Observations: Estimated glomerular filtration rate (eGFR) slope has demonstrated strong association with subsequent progression to ESKD. With adequate sample size, treatment effects in the range of 0.5 to 1.00 mL/min/1.73 m2/y had 96% probability of predicting CKD progression, defined as doubling of serum creatinine, eGFR less than 15 mL/min/1.73 m2, or ESKD. eGFR slope can be used in patients with higher baseline values and may provide CKD progression insights when few hard kidney events are observed, especially in trials with limited follow-up. However, among trials that have determined eGFR slope, significant variations exist regarding inclusion of baseline values, calculation of eGFR values, and the follow-up period, which make it difficult to compare and gauge the incremental benefit of the interventions. There are multiple challenges in computing eGFR slope in cardiovascular trials, such as accounting for initial eGFR dip, nonlinearity, and heteroscedasticity. Conclusions and Relevance: eGFR slope may serve as a valuable marker to determine progression of CKD in cardiovascular trials. Further work is required to standardize data collection, follow-up duration, time points for kidney function assessment, and analytic methods to compute eGFR slope in cardiovascular trials.

Kidney function assessment and endpoint ascertainment in clinical trials.

Heterogeneity in the reporting of kidney function, kidney outcomes, and definitions for kidney endpoints in clinical trials makes it challenging to compare results and gauge incremental benefit of interventions across trials. We conducted a systematic review of the ascertainment of baseline kidney variables, reporting of kidney endpoints, and definitions used to characterize these endpoints in type 2 diabetes mellitus (T2DM), kidney, and heart failure (HF) trials. Medline, Scopus, and ClinicalTrials.gov were searched from January 2014 through January 2021 for large (>1000 participants) T2DM, HF, and kidney disease trials and their secondary analyses. Trial publication and supplementary appendices were searched to abstract relevant data. Thirty-three trials (16 T2DM; 10 HF; 7 kidney diseases) were included. Thirteen trials did not include patients with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 and for trials that did, representation of this cohort ranged from 0.1% to 15%. Reporting of baseline kidney function and albuminuria remained low, especially in HF trials. Variability was observed in the definition of chronic kidney disease, sustained decline in eGFR, end-stage kidney disease, kidney death, and kidney composite endpoint across trials. eGFR slope was reported in less than half trials, with differences observed in statistical models, definition of acute or chronic slope, and follow-up duration across trials. Significant heterogeneity in reporting of kidney function and kidney outcomes in large T2DM, kidney, and HF trials underscores the need for future stakeholders to draft a consensus solution. Detailed profiling of patients at baseline, accrual of more patients with advanced kidney disease, and standardization of definitions in trials may improve the ability to compare the results across trials.

Healthcare Resource Utilization and Costs of Rivaroxaban Versus Warfarin Among Nonvalvular Atrial Fibrillation Patients with Obesity and Diabetes.

INTRODUCTION: Nonvalvular atrial fibrillation (NVAF) is associated with a substantial economic burden, particularly in patients with comorbid conditions. This study compared healthcare resource utilization (HRU) and costs of rivaroxaban and warfarin in patients with NVAF, obesity, and diabetes. METHODS: A de-identified healthcare claims database was used to identify adult patients newly initiating rivaroxaban or warfarin and having at least one medical claim with a diagnosis of AF, obesity determined by validated algorithm, and at least one claim with a diagnosis of diabetes or for antidiabetic medication from December 2011 to March 2020. Propensity score matching was used to balance the treatment cohorts on the basis of demographics and baseline characteristics. All-cause and NVAF-related HRU rates and costs were compared between treatments using rate ratios, and mean cost differences were calculated on a per patient per year (PPPY) basis. RESULTS: A total of 9999 matched pairs of patients with NVAF, obesity, and diabetes were identified in the rivaroxaban and warfarin cohorts. Rate ratios of all-cause HRU were significantly reduced with rivaroxaban versus warfarin in all healthcare settings evaluated, except emergency room visits. The greatest impact was on physician office visits followed by hospital outpatient and inpatient visits. NVAF-related HRU was significantly lower for rivaroxaban versus warfarin in all care settings. Consistent with these findings, the length of hospital stay was significantly reduced by approximately 4 days among all patients for both all-cause and NVAF-related hospitalizations in the rivaroxaban cohort compared with the warfarin cohort. Rivaroxaban was associated with reductions in all-cause total healthcare costs by more than $5000 PPPY and NVAF-related medical costs by approximately $1100 PPPY. CONCLUSION: In comparison with warfarin, rivaroxaban reduced HRU and costs, particularly hospital inpatient and outpatient visits and physician office visits, in patients with NVAF and comorbidities of obesity and diabetes.

People who are overweight or obese are at risk of developing atrial fibrillation (AF) along with other medical conditions, such as diabetes. Standard therapy with oral anticoagulants or blood thinners is recommended to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF (NVAF). In this study, we evaluated healthcare insurance claims for people with NVAF, obesity, and diabetes who started therapy with warfarin or rivaroxaban from 2011 to 2020 to compare the use and cost of healthcare services, such as hospitalizations and doctor visits, using diagnosis and procedure codes. The study included nearly 20,000 patients with similar characteristics. Patients who started treatment with rivaroxaban used fewer healthcare services for any cause and for those related to NVAF than those who started treatment with warfarin. The difference in use of services was largest for hospital outpatient and inpatient visits and doctor office visits; emergency room visits were only different for those related to NVAF. Length of hospital stay was also shorter for patients receiving rivaroxaban versus those receiving warfarin. These differences in healthcare service use translated into lower costs associated with rivaroxaban versus warfarin. The findings of this study suggest that treatment with rivaroxaban reduces the use of healthcare services compared with warfarin. This difference may be related, in part, to the reduced risks of stroke and systemic embolism observed in other real-world studies with rivaroxaban compared to warfarin. In addition, rivaroxaban does not require routine blood testing, which is required with warfarin treatment.

Effects of canagliflozin on serum potassium in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program.

BACKGROUND: The sodium-glucose cotransporter 2 inhibitor canagliflozin has been shown to reduce the risk of cardiovascular and renal events in patients with Type 2 diabetes mellitus and high risk. Pooled analyses of data from early studies and interim data from the CANagliflozin cardioVascular Assessment Study (CANVAS) suggested that canagliflozin might lead to increases in serum potassium, particularly the 300 mg dose in patients with renal impairment, which is important because high serum potassium is associated with increased cardiovascular and renal risk. We examined the effect of canagliflozin on serum potassium levels and hyperkalemia rates in the completed CANVAS Program. METHODS: The CANVAS Program (n = 10,142) was comprised of two comparable double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-Renal). Participants received canagliflozin 100 or 300 mg or placebo. Serum potassium measurements were performed in a central laboratory0 and assessed at ∼6-month intervals. RESULTS: In the CANVAS Program, mean potassium levels were generally consistent with canagliflozin and placebo, overall and by baseline estimated glomerular filtration rate (eGFR; ≥60, 45 to<60 and <45 mL/min/1.73 m2). The risk of increased or decreased potassium was similar with canagliflozin and placebo overall and by baseline eGFR (all P-heterogeneity ≥0.56) or use of renin-angiotensin-aldosterone system inhibitors (all P-heterogeneity ≥0.71); levels did not appear different by canagliflozin dose. Hyperkalemia {hazard ratio (HR) [95% confidence interval (CI)] 1.60 (0.92-2.81)} and serious hyperkalemia [HR (95% CI) 0.75 (0.27-2.11)] adverse events were not different across groups. CONCLUSIONS: In the CANVAS Program, there were no meaningful effects of canagliflozin on serum potassium in the overall population or key subgroups. Hyperkalemia adverse events were uncommon and occurred at comparable rates with canagliflozin and placebo.

Influence of Renal Function on the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Non-Vitamin K Antagonist Oral Anticoagulants.

With the growing integration of non-vitamin K antagonist oral anticoagulants (NOACs) into clinical practice, questions have arisen regarding their use in special populations, including groups that may have been underrepresented in clinical trials. Patients with renal impairment, particularly in the lower echelons of renal function, are one such group. In an effort to elucidate the current evidence regarding the use of NOACs in patients with renal impairment, a systematic assessment of the literature was performed. The MEDLINE database was interrogated for studies and analyses evaluating the influence of renal function on the pharmacokinetics, pharmacodynamics, efficacy, and safety of NOACs published from January 1, 2000, through August 2, 2017. The 82 relevant publications retrieved highlight the diversity in the NOAC class regarding the impact of renal function on drug clearance, drug exposures, and clinical trial outcomes. In several large clinical trials, subgroup analyses revealed no significant differences when patients were stratified by creatinine clearance as a measure of renal function. Efficacy findings, in particular, were largely aligned with the overall population in the included studies. However, relative risks of bleeding were shown to vary, sometimes driven by changes in bleeding event rates in the comparator arm (eg, warfarin, enoxaparin). With few exceptions, minimal influence of mild renal impairment was observed on the relative efficacy and safety of NOACs. Taken together, the evidence suggests that the presence of renal impairment merits careful consideration of anticoagulant choice but should not deter physicians from appropriate use of NOACs.

Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients.

BACKGROUND: African Americans have persistently poor access to living donor kidney transplants (LDKT). We conducted a small randomized trial to provide preliminary evidence of the effect of informational decision support and donor financial assistance interventions on African American hemodialysis patients' pursuit of LDKT. METHODS: Study participants were randomly assigned to receive (1) Usual Care; (2) the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED); or (3) PREPARED plus a living kidney donor financial assistance program. Our primary outcome was patients' actions to pursue LDKT (discussions with family, friends, or doctor; initiation or completion of the recipient LDKT medical evaluation; or identification of a donor). We also measured participants' attitudes, concerns, and perceptions of interventions' usefulness. RESULTS: Of 329 screened, 92 patients were eligible and randomized to Usual Care (n = 31), PREPARED (n = 30), or PREPARED plus financial assistance (n = 31). Most participants reported interventions helped their decision making about renal replacement treatments (62%). However there were no statistically significant improvements in LDKT actions among groups over 6 months. Further, no participants utilized the living donor financial assistance benefit. CONCLUSIONS: Findings suggest these interventions may need to be paired with personal support or navigation services to overcome key communication, logistical, and financial barriers to LDKT. TRIAL REGISTRATION: ClinicalTrials.gov [ NCT01439516 ] [August 31, 2011].

Expert Panel Recommendations for the Identification and Management of Hyperkalemia and Role of Patiromer in Patients with Chronic Kidney Disease and Heart Failure.

Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population. The panel noted that hyperkalemia is a serious condition that can lead to life-threatening complications, yet the treatment paradigm for hyperkalemia has remained without major advances for approximately 50 years, until the approval of patiromer. A number of issues still exist in the management of this patient population, including the lack of uniform treatment guidelines and consensus regarding the approach to treatment. As part of its effort, the panel developed an algorithm, the Proposed Diagnostic Algorithm for Hyperkalemia Treatment in the Acute Care Setting/Chronic Care. The panel agreed that patiromer appears to be a viable option for the management of hyperkalemia in patients with chronic kidney disease and/or heart failure and in patients who experience chronic hyperkalemia. DISCLOSURES: This panel discussion was funded by Relypsa and facilitated by Magellan Rx Management. Rafique is a principal investigator for Relypsa and serves as a consultant for Instrumentation Laboratory, Magellan Health, Relypsa, and ZS-Pharma. Butler serves as consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, CardioCell, Janssen, Merck, Novartis, Relypsa, and ZS-Pharma. Lopes and Farnum are employed by Magellan Rx Management. Rafique designed the management protocol for this panel discussion and contributed to the writing and editing of this report document. The other authors report no conflicting interests. Relypsa is the manufacturer of Veltassa (patiromer).

Assessment and management of hypertension in transplant patients.

Hypertension in renal transplant recipients is common and ranges from 50% to 80% in adult recipients and from 47% to 82% in pediatric recipients. Cardiovascular morbidity and mortality and shortened allograft survival are important consequences of inadequate control of hypertension. In this review, we examine the epidemiology, pathophysiology, and management considerations of post-transplant hypertension. Donor and recipient factors, acute and chronic allograft injury, and immunosuppressive medications may each explain some of the pathophysiology of post-transplant hypertension. As observed in other patient cohorts, renal artery stenosis and adrenal causes of hypertension may be important contributing factors. Notably, BP treatment goals for renal transplant recipients remain an enigma because there are no adequate randomized controlled trials to support a benefit from targeting lower BP levels on graft and patient survival. The potential for drug-drug interactions and altered pharmacokinetics and pharmacodynamics of the different antihypertensive medications need to be carefully considered. To date, no specific antihypertensive medications have been shown to be more effective than others at improving either patient or graft survival. Identifying the underlying pathophysiology and subsequent individualization of treatment goals are important for improving long-term patient and graft outcomes in these patients.

Cardiovascular risk assessment in kidney transplantation.

Cardiovascular disease (CVD) remains the most common cause of death after kidney transplantation worldwide, with the highest event rate in the early postoperative period. In an attempt to address this issue, screening for CVD prior to transplant is common, but the clinical utility of screening asymptomatic transplant candidates remains unclear. A large degree of variation exists among both transplant center practice patterns and clinical practice guidelines regarding who should be screened, and opinions are based on mixed observational data with great potential for bias. In this review, we discuss the potential risks, benefits, and evidence for screening for CVD in kidney transplant candidates, and also the next steps to better evaluate and treat asymptomatic kidney transplant candidates.

Assessment and management of hypertension in patients on dialysis.

Hypertension is common, difficult to diagnose, and poorly controlled among patients with ESRD. However, controversy surrounds the diagnosis and treatment of hypertension. Here, we describe the diagnosis, epidemiology, and management of hypertension in dialysis patients, and examine the data sparking debate over appropriate methods for diagnosing and treating hypertension. Furthermore, we consider the issues uniquely related to hypertension in pediatric dialysis patients. Future clinical trials designed to clarify the controversial results discussed here should lead to the implementation of diagnostic and therapeutic techniques that improve long-term cardiovascular outcomes in patients with ESRD.

Benefits Improvement and Protection Act's impact on transplantation rates among elderly MEDICARE beneficiaries with end-stage renal disease.

BACKGROUND: The Benefits Improvement and Protection Act (BIPA) expanded Medicare coverage for posttransplantation immunosuppresants for elderly patients and others eligible for Medicare beyond their end-stage renal disease (ESRD) status yet retained the 3-year limit for patients eligible solely because of ESRD status. Our objective was to determine BIPA's impact on renal transplantation among elderly patients (age ≥65 years) affected by BIPA. METHODS: Medicare claims and the U.S. Renal Data System Standard Analysis Files were used to analyze the likelihood of transplantation among elderly patients, all of whom were affected by BIPA, versus the nonelderly, many of whom were unaffected by BIPA. A difference-in-differences approach and generalized logistic regressions were used to estimate BIPA's impact. RESULTS: Analysis of data for 632,904 ESRD Medicare beneficiaries who met inclusion/exclusion criteria suggests that BIPA made elderly patients more likely (relative likelihood, 1.36; 95% confidence interval, 1.32-1.41) to have a transplant. The likelihood for nonelderly patients decreased following BIPA (relative likelihood, 0.93; 95% confidence interval, 0.92-0.94). CONCLUSION: Transplantation rates increased among those elderly patients, all of whom were affected by BIPA by extending immunosuppressant coverage under BIPA. These results suggest that removing financial barriers to posttransplantation care may positively impact transplantation rates yet raise questions regarding whether the law shifted transplants from younger to older patients.

Cost-effectiveness of lower targets for blood pressure and low-density lipoprotein cholesterol in diabetes: the Stop Atherosclerosis in Native Diabetics Study (SANDS) .

BACKGROUND: The Stop Atherosclerosis in Native Diabetics Study (SANDS) reported cardiovascular benefit of aggressive versus standard treatment targets for both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in diabetic individuals. OBJECTIVE: In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic BP ≤115 mmHg versus standard targets of LDL-C ≤100 mg/dL and systolic BP ≤130 mmHg. DESIGN: Randomized, open label blinded-to-endpoint 3-year trial. DATA SOURCES: SANDS clinical trial database, Quality of Wellbeing survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices. TARGET POPULATION: American Indians ≥ age 40 years with type 2 diabetes and no previous cardiovascular events. TIME HORIZON: April 2003 to July 2007. PERSPECTIVE: Health payer. INTERVENTIONS: Participants were randomized to aggressive versus standard groups with treatment algorithms defined for both. OUTCOME MEASURES: Incremental cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Compared with the standard group, the aggressive group had slightly lower costs of medical services (-$116) but a 54% greater cost for BP medication ($1,242) and a 116% greater cost for lipid-lowering medication ($2,863), resulting in an increased cost of $3,988 over 3 years. Those in the aggressively treated group gained 0.0480 quality-adjusted life-years (QALY) over the standard group. When a 3% discount rate for costs and outcomes was used, the resulting cost per QALY was $82,589. RESULTS OF SENSITIVITY ANALYSIS: The use of a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively. LIMITATIONS: This study was limited by use of a single ethnic group and by its 3-year duration. CONCLUSIONS: Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective because of the cost of the additional medications required to meet the lower targets. With the anticipated availability of generic versions of the BP and lipid-lowering drugs used in SANDS, the cost-effectiveness of this intervention should improve. Published by Elsevier Inc on behalf of the National Lipid Association.

Predictors of compliance with antihypertensive therapy in a high-risk medicaid population.

OBJECTIVE: To identify predictors of compliance with antihypertensive combination therapy in a Medicaid population. METHODS: Retrospective medical and pharmacy claims data for Maryland Medicaid patients receiving angiotensin converting enzyme inhibitors (ACEls)/hydrochlorothiazides (HCTZs) or ACEl/calcium channel blockers as fixed-dose combinations or separate agents during the period of January 1, 2002 to December 31, 2004, were analyzed. INCLUSION: Continuously enrolled patients 18 years and older and at least one year of follow-up. Exclusion: Use of fixed-dose combination antihypertensives between January 1, 2002 and June 30, 2002 (to identify incident cohort). Compliance was defined as medication possession ratio greater than or equal to 80%. Multivariate logistic regression was used to predict compliance as a function of age, gender, race, comorbidities (Charlson Comorbidity Index [CCI]), and use of either fixed-dose combination or separate agents. RESULTS: There were 568 patients, 63.73% female, 68.83% African American, median age 52 years, 35.56% on fixed-dose combinations, 72.89% started on ACEI/HCTZ, and 24.82% complied with therapy. Patients younger than 40 years (OR, 0.38; p = .01; 95% CI, 0.18-0.81) and African American (OR, 0.45; p = .0004; 95% CI, 0.29-0.70) were less likely to be compliant than patients older than 60 years and Caucasian, respectively, Patients with a CCI of 1 (OR, 2.11; p = .05; 95% CI, 1.01-4.40) and those on fixed-dose combinations (OR, 1.60; p = .02, 95% CI, 1.06-2.40) were more likely to be compliant than those with higher CCIs and on separate agents, respectively. CONCLUSION: Age, race, comorbidities, and simplified antihypertensive regimens were significant predictors of compliance. Higher compliance rates may enhance cardiovascular disease management outcomes.

Prescribing trends and drug budget impact of the ARBs in the UK.

OBJECTIVES: Angiotensin II receptor blockers (ARBs) were introduced into the UK antihypertensive drug market at a premium price relative to other antihypertensives during a period of evolving evidence about hypertension treatment. This study aimed to determine the UK antihypertensive drug budget impact as the first ARB market launched in December 1994 and what proportion of the increase was directly attributable to ARBs. METHODS: Prescriptions for oral antihypertensives were identified from The Health Improvement Network database. Drug prices were based on the Chemist & Druggist January 2005 pricelist estimating real expenditure growth. Expenditure increases were disaggregated into the number of patients receiving antihypertensive drug prescriptions, the number of antihypertensive prescriptions per patient treated, and the average drug expenditure per antihypertensive prescription. RESULTS: The annual ARB prescription frequency increased from 0.04% in 1995 to 6.57% in 2004. Expenditure for antihypertensive drugs was estimated at pound465,862,416 in 1995 and pound1,458,268,104 in 2004 (2005 values), reflecting a 213% real rate of increase. Use of ARBs accounted for only 9.3% (range: 5.8%-12.5%) of the average drug expenditure. Treatment prevalence rose from 11.30% in 1995 to 16.90% in 2004, while the average number of antihypertensive drug prescriptions per patient increased from 9.34 to 13.46 per year. The average expenditure per antihypertensive drug prescription increased over time reflecting a product shift toward more expensive therapies. CONCLUSIONS: ARBs accounted for only 9.3% of the 213% increase in antihypertensive drug expenditure after their introduction. A substantial portion of the impact reflected increases in treatment prevalence and in the number of prescriptions per patient.