The Veterans Health Administration (VHA) listed the infliximab (IFX) biosimilar, IFX-dyyb (Inflectra), on the Veterans Affairs National Formulary (VANF) in May 2017. In September 2018, biosimilar IFX-abda (Renflexis) became the VANF IFX product. The recommended formulary changes from one IFX biosimilar to another provided a unique opportunity to study IFX utilization patterns in IFX-na & iuml;ve Veterans with Inflammatory Bowel Disease (IBD). This study aimed to describe IFX and healthcare utilization during the 365 days after initiation with IFX reference product (RP) or biosimilars IFX-dyyb and IFX-adba. This descriptive study was performed using the VHA Corporate Data Warehouse. All Veterans initiated on IFX-RP (Remicade) or biosimilars IFX-dyyb and IFX-adba between September 1, 2016 and December 30, 2019 were included and followed for 365 days. Veterans enrolled in the VHA for at least 365 days with no evidence of IFX before their index date were considered IFX-na & iuml;ve. Continuous data on IFX use, laboratory measurements, and healthcare utilization were reported with means, 95% confidence interval (CI), medians, and interquartile ranges. Frequency, proportions, and 95% CIs were presented for categorical variables. Statistical tests included ANOVA and Kruskal-Wallis for continuous outcomes, Poisson regression for count-based outcomes (i.e., healthcare utilization visits), and Chi-square for dichotomous outcomes. The study identified 1763 IFX-na & iuml;ve patients with IBD, and 785, 441, and 537 was indexed to RP, IFX-dyyb, and IFX-adba, respectively. Statistical differences were observed in IFX utilization measures related to dosing, adherence, and persistence. The proportion of days covered (PDC) during the 365-day follow-up period varied among the IFX groups: IFX-RP at 66%, IFX-dyyb at 60%, and IFX-abda at 69% (P value < .001). Persistence with the index IFX product during the 365-day follow-up period also varied: IFX-RP at 43%, IFX-dyyb at 32%, and IFX-abda at 51% (P value < .001). Healthcare utilization and laboratory findings were similar among the IFX groups. IFX utilization and laboratory patterns were clinically similar among the IFX biosimilars and RP groups, suggesting that providers did not modify their practice with biosimilars. Statistically significant differences in IFX utilization patterns are explained by formulary dynamics when the VANF product switched from IFX-dyyb to IFX-abda.

To better inform clinicians about the use of etanercept biosimilar (SB4) in patients with rheumatoid arthritis (RA), COMPANION-B, a prospective real-world observational study, evaluated the effectiveness of the voluntary switch from originator (etanercept, ETN) to SB4 in patients with stable RA (low-disease activity/remission). The study recruited adult patients (18 years or older) with RA (2010 American College of Rheumatology criteria) prescribed ETN as their first or second biologic for at least 6 months across 14 sites in Canada and five in Australia. Patients had stable disease (Disease Activity Score-28 using erythrocyte sedimentation rate [DAS28-ESR] less than 3.2) at enrollment with no evidence of flare within the previous 3 months. Concomitant disease-modifying antirheumatic drugs (DMARDs) were permitted. Patients could elect to continue ETN or voluntarily switch to SB4 in consultation with their doctors. The primary effectiveness measure was the proportion of patients with disease worsening (defined as a DAS28-ESR increase of at least 1.2 from baseline and minimum score of at least 3.2 or a defined modification in RA treatment) during 12 months of follow-up. The secondary effectiveness measure was the proportion of patients with disease worsening at month 6. Serious adverse events (SAEs) and non-serious adverse reactions (NSARs) were recorded. Of 163 patients enrolled, 109 elected to continue on ETN and 54 switched to SB4; 65.8% of patients received non-biologic DMARD(s), 52.6% methotrexate, and 10.5% oral corticosteroid(s). At month 12, the proportion of patients with disease worsening was comparable in the ETN group (22.8% [95% CI 15.0–32.2]) and SB4 group (17.6% [95% CI 8.4–30.9]). Similarly, the proportions of patients with disease worsening were also comparable at month 6 (ETN: 7.9% [95% CI 3.5–15.0]; SB4: 7.8% [95% CI 2.2–18.9]). SAEs were low and similar across both groups (ETN: 8.7%; SB4: 5.7%). NSARs were slightly higher in the SB4 vs. ETN group (13.2% vs. 2.9%). SB4 demonstrated comparable effectiveness to ETN over 12 months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

BACKGROUND: The study objective was to describe utilization of infliximab (IFX) products, including the infliximab originator Remicade (IFX-orig) and biosimilars Inflectra (IFX-dyyb), and Renflexis (IFX-abda), during a 6-month follow-up period. METHODS: Data were collected from national Veterans Affairs (VA) administrative and electronic medical record datasets between September 1, 2016 to December 31, 2019. The index date was the first infliximab biosimilar dispensation date during the study period. Veterans were required to be enrolled in the VA for >365 days prior to their index date. Veterans were sub-grouped according to their history of infliximab exposure prior to the index date (IFX-naïve or IFX-experienced), and disease indication (Crohn’s Disease (CD), Ulcerative Colitis (UC), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Psoriasis (PsO), and Others). The distribution of patients on each IFX product was assessed over time. Persistence on the index product and proportion of patients switching to a different IFX product were determined. Other measures of IFX utilization included the average weight-based dose, cumulative dose, the number of dispensed doses, and proportion of days covered (PDC). RESULTS: Among 5,227 veterans, the mean age was 54.5 (95% CI: 54.1-55.0) years and 88.4 (87.6-89.3)% were male. 70.2 (69.0-71.4)% were initiated on IFX-orig, 13.4 (12.5-14.4)% IFX-dyyb, and 16.4 (15.4-17.4)% IFX-abda. 51.2 (49.9-52.6)% were IFX-naïve. Disease indications included CD (40.1 (38.7-41.4)%), UC (26.7 (25.5-27.9)%), RA (12.0 (11.1-12.9)%), AS (5.9 (5.3-6.6)%), PsA (5.4 (4.8-6.0)%), PsO (2.3 (1.9-2.7)%), and Others/Unknown (7.6 (6.9-8.4)%). The percentage of IFX users on a biosimilar increased between the beginning and end of the study (from 0.1% to 86%). The percentage of Veterans persistent on their index IFX product throughout the 6-month follow-up period was 78.2%. Within the subset of Veterans who were not persistent on their index IFX product, 26.4% switched to a different IFX product. The mean number of times IFX was dispensed during the 6-month follow-up was 4.25 (4.20-4.30) (IFX-orig 4.24 (4.19-4.30), IFX-dyyb 4.07 (3.93-4.22), IFX-abda 4.41 (4.28-4.53)). The average weight-based dose was 5.95 (5.89-6.01) mg/kg (IFX-orig 6.09 (6.02-6.17) mg/kg, IFX-dyyb 5.70 (5.56-5.83) mg/kg, IFX-abda 5.56 (5.44-5.67) mg/kg) and the mean cumulative dose was 2331.9 (2291.8-2371.9) mg (IFX-orig 2390.7(2341.7-2439.7) mg, IFX-dyyb 2120.1 (2015.9-2224.3) mg, IFX-abda 2253.3 (2162.9 – 2343.6) mg). The mean PDC was 0.86 (0.85-0.86) (IFX-orig 0.88 (0.87-0.88), IFX-dyyb 0.78 (0.76-0.80), IFX-abda 0.83 (0.81-0.85)). Additional IFX utilization data will be subsequently presented for the subpopulations with Crohn’s and UC. CONCLUSION: The percentage of IFX users on a biosimilar increased throughout the study period. Dosing outcomes and PDC were similar with IFX-orig, IFX-dyyb and IFX-abda, suggesting biosimilars were used in a similar manner as the originator product.

INTRODUCTION: This study described real world use of infliximab (IFX) products for Inflammatory Bowel Disease (IBD), within the context of Veterans Affairs National Formulary (VANF) Policy. IFX products included the IFX originator (IFX-orig) and biosimilars (IFX-dyyb, IFX-abda). FX-orig was replaced by IFX-dyyb as the preferred IFX product on the VANF in May 2017, and IFX-dyyb was replaced by IFX-abda in September 2018. Per policy, Veterans with prior IFX experience may continue using the non-formulary product, but IFX naïve initiators are directed to select the VANF product. The purpose of this study was to describe IFX product selection for Crohn’s Disease (CD) and Ulcerative Colitis (UC) during the time frame when biosimilars entered the VA and obtained VANF status. The secondary purpose was to describe IFX product use during the 1st six months of study follow-up. METHODS: Data sources included national electronic health record and administrative datasets generated from routine clinical care in the US. From 1/1/2016 to 12/31/2019, Veterans were included in the study upon receipt of their first IFX product. Eligible participants had a diagnosis code for UC or CD and had entered the VA >365 days prior to their index treatment. Monthly and annual IFX product selection was described for IFX-naïve and IFX-experienced patients. Frequency, proportions and 95% CIs were used to describe IBD cohort characteristics and initial IFX product selection during the study period. RESULTS: IFX products were used in 3204 Veterans with IBD (60.2% CD, 39.8 UC). The mean age was 52.5 and 90% were male (Table 1). Non-formulary use of IFX-orig occurred in higher percentage of IFX experienced patients than IFX-naïve patients (Table 2). Product selection reflected VANF, with the highest frequencies of IFX-orig in 2016–2017, IFX-dyyb during 2018, and IFX-abda during 2019. The time delay between the initial designation as the preferred IFX product and becoming the most frequently used IFX product in IFX-naïve Veterans was 5 months for IFX-dyyb and 2 months for IFX-abda (Figure 1). CONCLUSION: Adoption of the initial biosimilar added to VANF in May 2017 was slower than adoption of the Sept. 2018 formulary change. Additional work is needed to understand utilization patterns with IFX biosimilars vs non-formulary IFX products and reasons for delay in formulary compliance. Assessment of ongoing product use will provide important details on how VANF influences IFX use in patients with and without prior IFX experience.Table 1Table 2Figure 1: Patterns of IFX-orig and Biosimilar Use Over Time

Introduction: Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic autoimmune diseases associated with substantial health and economic burden. Remicade® (Infliximab, IFX) is indicated and used for treating moderate to severe patients with CD and UC. Treatment discontinuation risk varies between studies and factors associated with discontinuation are not well documented. This study assessed IFX treatment discontinuation risk and associated factors to shed light on ways to improve patient care. Methods: A retrospective cohort study was conducted using integrated inpatient and outpatient data from 483 hospitals in Premier Healthcare Database among patients aged ≥ 18 years; had a principal/secondary ICD-9/10 diagnosis code of CD or UC; had ≥1 IFX treatment at index visit; and had ≥ 1 and ≥2 outpatient visits during 12-month look-back and follow-up, respectively. IFX use at index visit was classified as New start (no IFX use during look-back) and Continuous (had IFX use during lookback). Cox proportional hazard modeling was used to assess predictors of IFX treatment discontinuation adjusting for known confounders. Results: 6934 CD (4278 New start; 2656 Continuous) and 3325 UC patients (2148 New start; 1177 Continuous) were analyzed. A higher percentage of new starters discontinued IFX than continuous patients for both conditions (CD: 48.2 % vs. 27.1%; UC: 44.1% vs. 36.6%, both pp<0.01). Multivariable analysis showed that risk of IFX discontinuation was associated with younger age (Hazard ratio [HR]=0.99, 95% Confidence Interval [CI]: 0.98, 0.99 for both CD and UC), IFX new start (CD: HR=1.39, 95% CI: 1.24, 1.57: UC: HR=1.41, 95% CI: 1.25, 1.58), public or no insurance at index visit, loss of insurance coverage (CD: HR=4.99, 95% CI: 3.31, 7.51; UC: HR=5.35, 95% CI: 2.99, 9.58), and blood stream infections during follow-up (CD: HR=1.69, 95% CI 1.19, 2.38; UC: HR=2.39, 95% CI:1.30, 4.35%). Conclusion: Over 44% of IFX new starters with either CD or UC discontinued IFX treatment. IFX new start, younger age, public or no insurance, loss of health insurance, and blood stream infections were associated with increased risk of IFX discontinuation. Healthcare providers need to closely monitor IFX patients particularly new starters for possible risk factors of discontinuation to ensure that they fully benefit from the medication before discontinuing or switching.

Introduction: Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys autoinjector compared to the currently available marketed Enbrel MYCLIC autoinjector (Australia) and Enbrel SureClick autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy.Methods: Patients (N = 191) reporting a diagnosis of RA and nurses and rheumatologists (N = 90) with experience managing RA were shown how to use Brenzys and Enbrel autoinjectors (in counterbalanced order between participants), then they used each autoinjector by injecting into a pad simulating skin, and completed a questionnaire. Study sessions took place in Australia and Canada.Results: A binomial test showed that significantly more patients indicated that the Brenzys autoinjector was easier to use than the Enbrel autoinjector (79% reporting Brenzys easier to use; p < 0.001, two-sided, 95% CI [73%, 85%]). In addition, significantly more nurses and rheumatologists with experience managing RA also indicated that the Brenzys autoinjector was easier to use (86%; p < 0.001, two-sided, 95% CI [77%, 92%) and that they would recommend the buttonless Brenzys autoinjector over the Enbrel autoinjector to patients (83%; p < 0.001, two-sided, 95% CI [74%, 90%]). Almost all patients who reported past experience using an Enbrel autoinjector (N = 17) reported on the basis of using the two devices in the study that they would prefer to switch their device to the Brenzys autoinjector rather than continue their course of therapy using the Enbrel autoinjector (16/17, 94%, 95% CI [71%, 100%]).Conclusion: On the basis of the study results, the Brenzys autoinjector was rated statistically significantly easier to use, and was overall preferred by patients and healthcare professionals with experience managing RA patients.Funding: Merck & Co., Inc.

Background: Patients with symptomatic peripheral artery disease (PAD) are at high risk of ischemic events. However, data about predictors of this risk are limited.Hypothesis: We analyzed baseline characteristics and 4-year follow-up of patients enrolled in the international REduction of Atherothrombosis for Continued Health (REACH) Registry with symptomatic PAD and no history of stroke/transient ischemic attack to describe annual rates of recurrent ischemic events globally and geographically.Methods: The primary outcome was systemic ischemic events (composite of cardiovascular death, myocardial infarction, or stroke) at 4 years. The secondary outcome was limb ischemic events (composite of lower limb amputation, peripheral bypass graft, and percutaneous intervention for PAD) at 2 years. Multivariate analysis identified risk factors associated with recurrent ischemic events.Results: The primary endpoint rate reached 4.7% during the first year and increased continuously (by 4%-5% each year) to 17.6% by year 4, driven mainly by cardiovascular mortality (11.1% at year 4). Japan experienced lower adjusted ischemic rates (P < 0.01) vs North America. Renal impairment (P < 0.01), congestive heart failure (P < 0.01), history of diabetes (P < 0.01), history of myocardial infarction (P = 0.01), vascular disease (single or poly, P < 0.01), and older age (P < 0.01) were associated with increased risk of systemic ischemic events, whereas statin use was associated with lower risk (P = 0.03). The limb ischemic event rate was 5.7% at 2 years.Conclusions: Four-year systemic ischemic risk in patients with PAD and no history of stroke or transient ischemic attack remains high, and was mainly driven by cardiovascular mortality.

BACKGROUND:Estimates of residual cardiovascular risks among patients who have experienced a recent acute myocardial infarction (MI) are predominantly derived from secondary prevention trial populations, patient registries, and population-based cohorts.OBJECTIVE:To generate real-world evidence of antiplatelet treatment and recurrent events following MI in patients on antiplatelet treatment among commercial, employer-based insured patients in a large administrative database.METHODS:This was a retrospective cohort claims database study using the Truven Health MarketScan Commercial Claims and Encounters and Medicare Supplemental databases between 2007-2011. Patients with an acute MI hospitalization with a discharge date between 2008 and 2010 were included. Excluded were those patients with documentation of stroke, transient ischemic attack (TIA), or severe bleeding at or before index hospitalization and with concomitant use of anticoagulant therapy following index hospitalization. Patients treated with clopidogrel following the index MI hospitalization were followed up to 1 year for repeat MI, stroke, and coronary revascularization.RESULTS:Among 33,943 post-MI continuous clopidogrel users without history of stroke, TIA, or bleeding, 22% had diabetes, whereas angina and renal impairment were less prevalent (5% and 7%, respectively). Over the 1-year follow-up, 2.4% experienced a repeat MI or stroke, and 8.2% underwent coronary revascularization. Angina, diabetes, and renal impairment were associated with elevated 1-year risk of repeat MI or stroke.CONCLUSIONS:This study suggests that there is residual cardiovascular risk, although relatively low, in an insured, secondary prevention population on antiplatelet treatment following an MI. In patients with MI, identifying angina, diabetes, and renal impairment may aid risk stratification and guide the effective management of these higher-risk patients.DISCLOSURES:Funding for this research was provided by Merck & Co. Although Merck & Co. formally reviewed a penultimate draft, the opinions expressed are those of the authorship and may not necessarily reflect those of the company. Reed Chase, Wu, Mavros, Heithoff, and Hanson are employees of Merck Sharp & Dohme, a subsidiary of Merck & Co., and may own stock and/or hold stock options in the company. Patel was an employee of Merck & Co. during the conduct of this study and preparation of the manuscript. Simpson is a paid consultant for Merck, Pfizer, and Amgen and has received speaker's fees from Merck and Pfizer. Study concept and design were contributed by all authors except Hanson. Heifhoff and Patel collected the data, and data interpretation was performed by Simpson, Mavros, Patel, Wu, and Hanson. The manuscript was written by Hanson, Mavros, and Patel and revised by Heithoff, Wu, Simpson, and Reed Chase.

Background Although the rate of in‐hospital ischemic events after myocardial infarction ( MI ) has dramatically decreased, long‐term residual risk may remain substantial. However, most of the information on current residual risk is derived from highly selected randomized trials. Hypothesis In patients with previous MI and no prior ischemic stroke/transient ischemic attack (TIA), residual ischemic risk increases over time. Methods Using the international Reduction of Atherothrombosis for Continued Health ( REACH ) registry, we analyzed baseline characteristics and 4‐year follow‐up of patients with previous MI and no history of stroke/ TIA to describe annual rates of recurrent ischemic events globally and by geography. The primary outcome was the composite of cardiovascular death, MI , or stroke. Multivariate analysis identified risk factors associated with recurrent ischemic events. Results Data from 16 770 patients enrolled at 5587 sites in 44 countries were analyzed. The rate of the primary outcome increased annually from 4.7% during year 1 to reach a 4‐year rate of 15.1%. Compared with North America, Japan experienced lower ischemic event rates ( P < 0.01), whereas Eastern Europe ( P < 0.01) and the Middle East ( P = 0.01) experienced higher ischemic event rates. The presence of congestive heart failure, polyvascular disease, diabetes, atrial fibrillation or flutter, and older age were associated with increased residual risk (all P < 0.01). Statin use was associated with lower ischemic risk ( P < 0.01). Conclusions In this study, residual ischemic risk after MI accrued progressively up to 4 years of follow‐up, emphasizing the value of intensive secondary prevention strategies to minimize residual risk.

Hypertension, a risk factor for cardiovascular disease (CVD), is frequently associated with other CVD risk factors. Despite recent improvement in blood pressure (BP) control in Europe, a substantial proportion of patients fail to achieve BP targets.

Data from four clinical trials compared reductions in systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) among patients treated with amlodipine/losartan 5/50 mg vs 5/100 mg and amlodipine/losartan 5/50 mg vs amlodipine 5 mg and 10 mg. Response rate was assessed as reduction in SBP or DBP (>20/10 mm Hg) and proportion of patients achieving SBP <140 mm Hg or DBP <90 mm Hg. Patients were grouped into quartiles based on baseline SBP and DBP . Mean SBP and DBP were reduced in amlodipine/losartan 5/50 mg (n=182) and amlodipine/losartan 5/100 mg (n=95) users across all baseline quartiles. Patients using amlodipine/losartan 5/50 mg had significantly greater SBP and DBP reductions vs amlodipine 5 mg ( P =.001 and P =.02, respectively). Amlodipine/losartan 5/50 mg users had significantly greater SBP reduction vs amlodipine 10 mg ( SBP P =.02; DBP P = not significant ). The odds of responding to therapy were significantly greater with amlodipine/losartan 5/50 mg vs amlodipine 5 mg ( odds ratio, 5.33; 95% confidence interval, 1.42–25.5) and were similar vs amlodipine 10 mg ( odds ratio, 0.67; 95% confidence interval, 0.017–9.51). These results support the use of combination therapy early in the treatment of hypertension.

Microalbuminuria is an early sign of nephropathy and an independent predictor of end-stage renal disease. The purpose of this study was to assess microalbuminuria prevalence and its contributing factors in Korean hypertensive patients. This cross-sectional study enrolled male and female patients of ⩾35 years old with an essential hypertension diagnosis as made by 841 physicians in primary care clinics and 17 in general hospitals in the Republic of Korea between November 2008 and July 2009. To assess microalbuminuria prevalence, urine albumin/creatinine ratio (UACR) was measured in patients with a positive dipstick test. Of the 40 473 enrolled patients, 5713 (14.1%) had a positive dipstick test. Of 5393 patients with a positive dipstick test and valid UACR values, 2657 (6.6%) had significantly elevated UACR (⩾30 μg mg−1), 2158 (5.4%) had microalbuminuria (30 μg mg−1⩽UACR <300 μg mg−1) and 499 (1.2%) had macroalbuminuria (UACR ⩾300 μg mg−1). Based on multivariate analysis, independent factors associated with elevated UACR included low adherence to antihypertensive medication (23% higher; P=0.042), poorly controlled blood pressure (BP; 38% higher for systolic BP/diastolic BP ⩾130 mm Hg/⩾80 mm Hg; P<0.001), obesity (47% higher for body mass index (BMI) ⩾25.0 kg m−2; P<0.001), age (17% lower and 58% higher for age categories 35–44 years (P=0.043) and >75 years (P<0.001), respectively) and a prior history of diabetes (151% higher; P<0.001) and kidney-related disease (71% higher; P<0.001). The prevalences of elevated UACR and microalbuminuria were 6.6% and 5.4%, respectively. Age, increased BMI, presence of comorbidities, poor medication adherence and inadequately controlled BP were independent predictors of elevated UACR after controlling for potential confounders.

Worsened renal function (WRF) during heart failure (HF) hospitalization is associated with in-hospital mortality, but there are limited data regarding its relation to long-term outcomes after discharge. The influence of WRF resolution is also unknown. This retrospective study analyzed patients who received care from a large health system and had a primary hospital discharge diagnosis of HF from January 2000 to June 2008. Renal function was estimated from creatinine levels during hospitalization. The first available value was considered baseline. WRF was defined a creatinine increase >= 0.3 mg/dl on any subsequent hospital day compared to baseline. Persistent WRF was defined as having WRF at discharge. Proportional hazards regression, adjusting for baseline renal function and potential confounding factors, was used to assess time to rehospitalization or death. Of 2,465 patients who survived to discharge, 887 (36%) developed WRF. Median follow-up was 2.1 years. In adjusted models, WRF was associated with higher rates of postdischarge death or rehospitalization (hazard ratio [HR] 1.12, 95% confidence interval [CI] 1.02 to 1.22). Of those with WRF, 528 (60%) had persistent WRF, whereas 359 (40%) recovered. Persistent WRF was significantly associated with higher postdischarge event rates (HR 1.14, 95% CI 1.02 to 1.27), whereas transient WRF showed only a nonsignificant trend toward risk (HR 1.09, 95% CI 0.96 to 1.24). In conclusion, in patients surviving hospitalization for HF, WRF was associated with increased long-term mortality and rehospitalization, particularly if renal function did not recover by the time of discharge. (c) 2011 Elsevier Inc. All rights reserved. (Am J Cardiol 2011;107:74-78)

This study compared the prevalence of high-risk cardiovascular (CV) conditions, antihypertensive medication treatment patterns, and demographic and clinical characteristics associated with blood pressure (BP) goal attainment between elderly (65 years and older) and nonelderly (younger than 65 years) adults with hypertension. Retrospective cohort study was conducted using an electronic medical record database among patients receiving at least 1 antihypertensive medication. CV risk profiles were assessed by International Classification of Diseases, 9th Revision diagnosis codes. Treatment patterns were assessed by the number of antihypertensive medications prescribed. BP goal attainment was determined by the mean of the last 2 BP readings during 1 year of follow-up. Logistic regression estimated the odds of achieving BP goal. There were 61,355 nonelderly (mean age, 51.8 years) and 47,796 elderly (mean age, 73.2 years) patients in the study. Elderly patients had statistically significant higher levels of isolated systolic hypertension and complicated hypertension. Elderly patients had statistically significant higher levels of prescribing patterns characterized by multiple antihypertensive medications but statistically significant lower levels of BP goal attainment. Age 65 years and older, African American race, body mass index ≥30, and the presence of complicated hypertension were found to be statistically significant factors contributing to a lower likelihood of BP goal attainment. Despite aggressive antihypertensive treatment, elderly patients are less likely to achieve BP goals.

Renal impairment frequently accompanies heart failure (HF) and is a recognized independent risk factor for morbidity and mortality. Few data are available assessing the impact of worsening renal function (WRF) during hospitalization on health care resource use in patients with HF. Health Insurance Portability and Accountability Act-compliant, de-identified, clinical, laboratory, and economic data for patients admitted to a tertiary care medical center with a primary diagnosis of HF were extracted by MedMining and reviewed retrospectively by the authors. Patients were excluded if they had no previous HF or were admitted for acute coronary syndrome or coronary artery bypass grafting within 30 days of index hospitalization. WRF was defined as ≥ 0.3 mg/dl increase in serum creatinine from baseline at any time during hospitalization. Of 5,803 hospitalized patients with primary HF diagnosis, 827 patients (14%) fulfilled all prespecified inclusion and exclusion criteria (74 ± 14 years of age, 43% men, 98% white, admission serum creatinine 1.4 ± 0.9 mg/dl, estimated glomerular filtration rate < 90 ml/min/1.73 m(2) at admission in 83%). During index hospitalization, WRF was identified in nearly 33%. Compared to patients without WRF, those with WRF had greater prevalence of diabetes (54% vs 43%), lower estimated glomerular filtration rate (44 ± 30 vs 62 ± 35 ml/min/1.73 m(2)), higher serum potassium (4.3 ± 0.7 vs 4.2 ± 0.7 mEq/L), and higher B-type natriuretic peptide (845 ± 821 vs 795 ± 947 pg/ml) at baseline (all p values < 0.05). Patients developing WRF incurred higher total inpatient costs ($10,977, range 671 to 212,819, vs $7,820, range 697 to 269,797, p < 0.001) and longer hospital stay (8.2 ± 6.8 vs 5.7 ± 5.5 days, p < 0.001). In conclusion, occurrence of WRF during HF-related hospitalization is associated with higher hospitalization costs and longer hospital stay.

Background: Worsening renal function (WRF) during heart failure hospitalization is an accepted correlate of poor prognosis including increased mortality and re-hospitalization. However, for some patients WRF is transient while for others it persists. The likelihood and predictors that WRF will persist to discharge have not been described. Methods: This was a retrospective cohort study of patients who received care from a large health system in southeast Michigan and had a primary hospital discharge diagnosis of heart failure between Jan 1, 2000 and June 30, 2008. Patients with preexisting end-stage renal disease were excluded. Renal function during the index hospitalization was assessed using serial creatinine (Cr) measurements. The first Cr value during hospitalization or in the emergency department was considered baseline. WRF was defined as ≥0.3mg/dl increase in Cr on any subsequent hospital day compared to baseline. Persistence was defined as the subject meeting the WRF definition at the last available Cr value during hospitalization. Logistic regression with stepwise selection was used to assess the relationship of patient factors to persistence at discharge. Factors examined were age, race, gender, baseline Cr, atrial fibrillation, diabetes, hypertension, vascular disease, stroke, heart failure, and coronary disease. Results: Among the 7430 patients meeting inclusion criteria, 51% were female, 68% were African American, and average baseline Cr was 1.36 mg/dl. Overall, 2,876 (38.7%) patients developed WRF during hospitalization. Of the patients with WRF, 1740 (60.5%) had persistent dysfunction at the time of discharge. African American race (OR 1.46 95%CI 1.23 - 1.72), older age (OR 1.09 per decade; 95% CI 1.03 -1.15), and coronary disease (OR 1.23; 95% CI 1.02-1.47) were independently associated with a greater likelihood of persistent WRF. Conclusions: Approximately 40% of patients hospitalized for acute heart failure developed WRF, and 60% of those who developed WRF failed to recover from it by discharge. African American patients, older patients, and those with coronary disease were at greater risk of persistent WRF. Further study is needed to better understand why renal dysfunction persists more often in these groups, and define the prognostic import of persistent WRF in the hospital.