Juan Maya

Discharge heart rate and β-blocker dose in patients hospitalized with heart failure: Findings from the OPTIMIZE-HF registry

BACKGROUND Elevated heart rate of ≥70 beats/min despite β-blocker use may represent a new treatment target in patients in sinus rhythm with heart failure with reduced ejection fraction. However, little is known about the proportion of patients with elevated heart rate despite β-blocker therapy. METHODS We analyzed data from a large clinical registry to describe discharge heart rate as a function of β-blocker use and dose. We included patients with left ventricular ejection fraction <40% who were admitted with acute heart failure in 2003 and 2004; we excluded patients with a history of atrial arrhythmia or with a pacemaker or cardiac resynchronization therapy. We considered the β-blockers carvedilol, metoprolol succinate, bisoprolol, atenolol, and metoprolol tartrate and described discharge dose as a percentage of target dose (ie, <25%, 25%-49%, 50%-99%, and ≥100%). RESULTS Among 10,696 patients, median discharge heart rate was 76 beats/min (interquartile range [IQR] 66-86 beats/min). Of these, 7,826 (73%) were discharged on a β-blocker. For patients not on a β-blocker, median discharge heart rate was 80 beats/min (IQR 70-89 beats/min), compared with 78 beats/min (IQR 69-88 beats/min) on <25% of target dose, 75 beats/min (IQR 66-85 beats/min) on 25% to 49% of target dose, 74 beats/min (IQR 66-82 beats/min) on 50% to 99% of target dose, and 72 beats/min (IQR 65% to 80%) on 100% of target dose or greater (P < .001). Most patients, 7,647 (71%), had a discharge heart rate of ≥70 beats/min, including 1,460 (63%) of 2,301 patients discharged on 50% of target dose or greater. CONCLUSIONS Despite treatment with β-blockers, a substantial proportion of patients hospitalized with heart failure with reduced ejection fraction have elevated heart rate at discharge.

Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction

The epidemiological, clinical, and societal implications of the heart failure (HF) epidemic cannot be overemphasized. Approximately half of all HF patients have HF with preserved ejection fraction (HFpEF). HFpEF is largely a syndrome of the elderly, and with aging of the population, the proportion of patients with HFpEF is expected to grow. Currently, there is no drug known to improve mortality or hospitalization risk for these patients. Besides mortality and hospitalization, it is imperative to realize that patients with HFpEF have significant impairment in their functional capacity and their quality of life on a daily basis, underscoring the need for these parameters to ideally be incorporated within a regulatory pathway for drug approval. Although attempts should continue to explore therapies to reduce the risk of mortality or hospitalization for these patients, efforts should also be directed to improve other patient-centric concerns, such as functional capacity and quality of life. To initiate a dialogue about the compelling need for and the challenges in developing such alternative endpoints for patients with HFpEF, the US Food and Drug Administration on November 12, 2015, facilitated a meeting represented by clinicians, academia, industry, and regulatory agencies. This document summarizes the discussion from this meeting.

Economic burden of hospitalizations of Medicare beneficiaries with heart failure

Objective The objective of this study was to assess the costs associated with the hospitalization and the cumulative 30-, 60-, and 90-day readmission rates in a cohort of Medicare beneficiaries with heart failure (HF). Methods This was a retrospective, observational study based on data from the national 5% sample of Medicare beneficiaries. Inpatient data were gathered for Medicare beneficiaries with at least one HF-related hospitalization between July 1, 2005, and December 31, 2011. The primary end point was the average per-patient cost of hospitalization for individuals with HF. Secondary end points included the cumulative rate of hospitalization, the average length of hospital stay, and the cumulative 30-, 60-, and 90-day readmission rates. Results Data from 63,678 patients with a mean age of 81.8 years were included in the analysis. All costs were inflated to

Pharmacotherapy Treatment Patterns, Outcomes, and Health Resource Utilization Among Patients with Heart Failure with Reduced Ejection Fraction at a U.S. Academic Medical Center.

2,015 based on the medical care component of the Consumer Price Index. The mean per-patient cost of an HF-related hospitalization was

Efficacy Profile of Ivabradine in Patients with Heart Failure plus Angina Pectoris

14,631. The mean per-patient cost of a cardiovascular (CV)-related or all-cause hospitalization was

Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy

16,000 and

Relation of Elevated Heart Rate in Patients With Heart Failure With Reduced Ejection Fraction to One-Year Outcomes and Costs

15,924, respectively. The cumulative rate of all-cause hospitalization was 218.8 admissions per 100 person-years, and the median length of stay for HF-related, CV-related, and all-cause hospitalizations was 5 days. Also, 22.3% of patients were readmitted within 30 days, 33.3% were readmitted within 60 days, and 40.2% were readmitted within 90 days. Conclusion The costs associated with hospitalization for Medicare beneficiaries with HF are substantial and are compounded by a high rate of readmission.

Heart rate, beta-blocker use, and outcomes of heart failure with reduced ejection fraction

To assess clinical characteristics, pharmacotherapy treatment patterns, resource utilization and associated charges, and morbidity and mortality outcomes among a real‐world cohort of patients with heart failure with reduced ejection fraction (HFrEF) in an academic medical center setting.

Financial impact of ivabradine on reducing heart failure penalties under the Hospital Readmission Reduction Program

Objectives: In the Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT), slowing of the heart rate with ivabradine reduced cardiovascular death or heart failure hospitalizations among patients with systolic chronic heart failure (CHF). Subsequently, in the Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients with Coronary Artery Disease (SIGNIFY) slowing of the heart rate in patients without CHF provided no benefit for cardiovascular death or nonfatal myocardial infarction (primary composite end point), with secondary analyses suggesting possible harm in the angina subgroup. Therefore, we examined the impact of ivabradine in the patients with CHF plus angina in SHIFT. Methods: SHIFT enrolled adults with stable, symptomatic CHF, a left ventricular ejection fraction ≤35% and a sinus rhythm with a resting heart rate ≥70 bpm. Outcomes were the SHIFT and SIGNIFY primary composite end points and their components. Results: Of 6,505 patients in SHIFT, 2,220 (34%) reported angina at randomization. Ivabradine numerically, but not significantly, reduced the SIGNIFY primary composite end point by 8, 11 and 11% in the SHIFT angina subgroup, nonangina subgroup and overall population, respectively. Ivabradine also reduced the SHIFT primary composite end point in all 3 subgroups. Conclusions: In SHIFT, ivabradine showed consistent reduction of cardiovascular outcomes in patients with CHF; similar results were seen in the subgroup of SHIFT patients with angina.

BETA BLOCKER DOSAGE AND USE OVER TIME IN THE SYSTOLIC HEART FAILURE TREATMENT WITH THE IF INHIBITOR IVABRADINE TRIAL (SHIFT) STUDY

Importance Although PCSK9 inhibitors (PCSK9i) were approved in 2015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK9i in clinical practice has been low. Objective To evaluate patient access to PCSK9i among those prescribed therapy. Design, Setting, and Participants Using pharmacy transaction data, we evaluated 45 029 patients who were newly prescribed PCSK9i in the United States between August 1, 2015, and July 31, 2016. Main Outcomes and Measures The proportion of PCSK9i prescriptions approved and abandoned (approved but unfilled); multivariable analyses examined factors associated with approval/abandonment including payor, prescriber specialty, pharmacy benefit manager, out-of-pocket cost (copay), clinical diagnoses, lipid-lowering medication use, and low-density lipoprotein cholesterol levels. Results Of patients given an incident PCSK9i prescription, 51.2% were women, 56.6% were 65 years or older, and 52.5% had governmental insurance. Of the patients given a prescription, 20.8% received approval on the first day, and 47.2% ever received approval. Of those approved, 65.3% filled the prescription, resulting in 30.9% of those prescribed PCSK9i ever receiving therapy. After adjustment, patients who were older, male, and had atherosclerotic cardiovascular disease were more likely to be approved, but approval rates did not vary by patient low-density lipoprotein cholesterol level nor statin use. Other factors associated with drug approval included having government vs commercial insurance (odds ratio [OR], 3.3; 95% CI, 2.8-3.8), and those filled at a specialty vs retail pharmacy (OR, 1.96; 95% CI, 1.66-2.33). Approval rates varied nearly 3-fold among the top 10 largest pharmacy benefit managers. Prescription abandonment by patients was most associated with copay costs (C statistic, 0.86); with abandonment rates ranging from 7.5% for those with