Safety of enoxaparin in patients implanted with continuous flow left ventricular assist devices.

Background: The objective of this study is to determine the incidence of major bleeding events in patients implanted with continuous flow left ventricular assist devices (CF-LVADs) bridged with enoxaparin (LMWH) compared to intravenous unfractionated heparin (IV UFH) for a subtherapeutic INR on warfarin.

Methods: A single-center, retrospective, cohort study was conducted including patients with CF-LVADs implanted between January 1, 2012 and July 1, 2020 who received at least one inpatient dose or outpatient prescription for LMWH or IV UFH at least 60 days after CF-LVAD implantation. The primary endpoint was the incidence of major bleeding.

Small interfering ribonucleic acid for cholesterol lowering - Inclisiran: Inclisiran for cholesterol lowering.

Despite the development of new therapies to lower cardiovascular disease (CVD) risk in recent decades, the trend of reductions in CVD mortality has reversed. New therapies are essential for the prevention of first and recurrent CVD. The importance of lowering low-density lipoprotein cholesterol (LDL-C) in the management and prevention of atherosclerotic CVD (ASCVD) is widely reflected in clinical treatment guidelines; however, most patients with established ASCVD do not achieve guideline-recommended LDL-C targets.

Sleep Outcomes From AWAKE-HF: A Randomized Clinical Trial of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection Fraction.

Background: Heart failure and sleep-disordered breathing have been increasingly recognized as co-occurring conditions. Their bidirectional relationship warrants investigation into whether heart failure therapy improves sleep and sleep-disordered breathing. We sought to explore the effect of treatment with sacubitril/valsartan on sleep-related endpoints from the AWAKE-HF study.

Documentation of asthma control and severity in pediatrics: analysis of national office-based visits.

To evaluate the extent of documentation of asthma control and severity and associated characteristics among pediatric asthma patients in office-based settings. This cross-sectional study utilized data from the 2012-2015 National Ambulatory Medical Care Survey (NAMCS). Patients aged 6-17 years with a diagnosis of asthma were included.

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence.

Importance: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) (also known as chronic spontaneous urticaria) in adolescents and adults with persistent hives not controlled with antihistamines. The effectiveness of omalizumab in the real-world management of CIU is largely unknown.

Objective: To quantitatively synthesize what is known about the benefits and harms of omalizumab in the real-world clinical management of CIU regarding urticaria activity, treatment response, and adverse events.

Women manifest more severe COPD symptoms across the life course.

Background: Previous studies suggest that gender differences exist in COPD diagnosis and symptoms; these differences may be more pronounced in younger adults. Our objective was to explore age-associated gender differences across a range of COPD severities.

Materials And Methods: A total of 4,484 current and former smokers with COPD from the Genetic Epidemiology of COPD cohort were investigated using regression modeling to explore the association between gender, age, disease severity, and the contributing elements of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification system (symptoms, exacerbation risk, airflow limitation).

Incidence of febrile neutropenia during chemotherapy among patients with nonmyeloid cancer receiving filgrastim vs a filgrastim biosimilar.

Background: Filgrastim and other granulocyte colony-stimulating factors are recommended to decrease febrile neutropenia (FN) incidence among patients with nonmyeloid cancers undergoing chemotherapy. Data comparing biosimilar filgrastim-sndz with reference filgrastim (filgrastim-ref) are limited outside of clinical trials in the US.

Objective: To compare the incidence of FN across chemotherapy cycles 1-6 between patients treated with filgrastim-sndz vs filgrastim-ref.

Lyme Disease Transmission Risk: Seasonal Variation in the Built Environment.

Seasonal variation in spatial distribution and pathogen prevalence of in blacklegged ticks () influences human population risk of Lyme disease in peri-urban built environments. Parks, gardens, playgrounds, school campuses and neighborhoods represent a significant risk for Lyme disease transmission. From June 2012 through May 2014, ticks were collected using 1 m² corduroy cloths dragged over low-lying vegetation parallel to walkways with high human foot traffic.

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of 'real-world' evidence.

Introduction: Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice.

Response of older patients with IgE-mediated asthma to omalizumab: a pooled analysis.

Asthma in older adults is under-recognized and possibly associated with allergic triggers. We conducted a pooled analysis of omalizumab double-blind, placebo-controlled trials to evaluate efficacy in older adults. Data for the total study population and subjects aged > or = 50 years with moderate-severe allergic asthma were examined.

Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests.

We deal with the design problem of early phase dose-finding clinical trials with monotone biologic endpoints, such as biological measurements, laboratory values of serum level, and gene expression. A specific objective of this type of trial is to identify the minimum dose that exhibits adequate drug activity and shifts the mean of the endpoint from a zero dose to the so-called minimum effective dose. Stepwise test procedures for dose finding have been well studied in the context of nonhuman studies where the sampling plan is done in one stage.

Safety and efficacy of oral terbinafine in the treatment of onychomycosis: analysis of the elderly subgroup in Improving Results in ONychomycosis-Concomitant Lamisil and Debridement (IRON-CLAD), an open-label, randomized trial.

Objectives: The primary objective of this subanalysis was to examine the safety, tolerability, and efficacy of terbinafine in the treatment of toenail onychomycosis in the patients aged > or = 65 years in the Improving Results in Onychomycosis Concomitant Lamisil And Debridement (IRON-CLAD) trial. (Lamisil and IRON-CLAD are trademarks of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.) The secondary objective was to determine if toenail debridement would provide additional efficacy benefits in this subgroup.

A bootstrap-based test for establishing noninferiority in clinical trials.

A randomized, active-control clinical trial setting with the objective of testing noninferiority for a continuous response variable is considered. Noninferiority margin is based on the concept of preserving a certain fraction of the active control effect. Noninferiority is established if the ratio of the lower (upper) limit of the two-sided 95% confidence interval for the treatment difference to the estimated mean of the active control is greater (less) than a certain fraction.