Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery.

BACKGROUND: Ticagrelor is a reversible oral P2Y12 platelet inhibitor used to treat patients with acute coronary syndromes, prior myocardial infarction, high-risk coronary artery disease, transient ischemic attack, or ischemic stroke. A healthy volunteer study showed that the intravenous monoclonal antibody bentracimab rapidly reverses ticagrelor, but the effect in patients was unknown. METHODS: In a prespecified interim analysis of a single-arm, prospective study, bentracimab was evaluated in ticagrelor-treated patients who required urgent surgery or had major hemorrhage.

Efficacy of Reslizumab Treatment in Exacerbation-Prone Patients with Severe Eosinophilic Asthma.

Background: Patients with severe eosinophilic asthma have increased risk of clinical asthma exacerbations (CAEs), impaired lung function, and lower quality of life (QoL) compared with patients with noneosinophilic asthma. The efficacy and safety of intravenous reslizumab have been demonstrated in 2 duplicate, randomized, double-blind, placebo-controlled, phase 3 studies.

Objective: We present findings from post hoc analyses of the subgroup of patients from the phase 3 studies with severe (Global Initiative for Asthma [GINA] Step 4 or 5) eosinophilic asthma who had ≥2 or ≥3 CAEs in the 12 months before screening.

In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV reversibility.

Background: A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials of intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma.

Methods: Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV) reversibility to β-agonists and treatment outcomes were assessed.

Results: Mean baseline FEV reversibility was numerically lower among patients with high (≥ 400 cells/µL) versus low baseline EOS.

Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials.

Background: Reslizumab 3 mg/kg administered intravenously is approved for the treatment of severe eosinophilic asthma. We assessed the safety and efficacy of subcutaneous reslizumab 110 mg in two trials in patients with uncontrolled severe asthma and increased blood eosinophils. The aim was to establish whether subcutaneous reslizumab 110 mg can reduce exacerbation rates in these patients (study 1) or reduce maintenance oral corticosteroid dose in patients with corticosteroid-dependent asthma (study 2).

Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma.

Background: Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.

Objective: To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.

Methods: We report post hoc analyses of pooled data from duplicate, placebo-controlled phase 3 trials.

Effect of Peanut Ball and Position Changes in Women Laboring With an Epidural.

Objective: To examine the effect of a nurse-driven intervention using a peanut ball (PB) with position changes on length of labor and incidence of cesarean birth among women who receive epidural anesthesia.

Design: Quasiexperimental comparison group design.

Setting/local Problem: A 407-bed, nonprofit, Magnet-designated, Baby-Friendly Hospital Initiative-designated hospital with 8 labor and delivery suites and an average of 100 births per month.

Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone.

Introduction: Handheld spirometers for home use by patients allow longitudinal spirometry data to be collected daily and may overcome some of the limitations of in-clinic spirometry (long intervals between measurements, results can be affected by site-based coaching and patient's asthma status during a given visit).

Objectives: To determine the relationship between spirometry values measured by clinic-based and handheld spirometers during a clinical trial.

Methods: A post hoc correlation analysis of data from a 6-week phase 3 study of beclomethasone dipropionate (BDP; delivered by breath-actuated inhaler: BAI) versus placebo in patients aged ≥12 years with persistent asthma.

Intravenous Calcium-/Zinc-Diethylene Triamine Penta-Acetic Acid in Patients With Presumed Gadolinium Deposition Disease: A Preliminary Report on 25 Patients.

Objectives: The aim of this study was to report the use of intravenous calcium (Ca)-/zinc (Zn)-diethylene triamine penta-acetic acid (DTPA) for the treatment of 25 symptomatic patients diagnosed with gadolinium deposition disease (GDD).

Materials And Methods: Written informed consent was obtained. Twenty-five patients (18 women; mean age, 46.

Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma.

Background: Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI).

Objective: To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.

Methods: This 6-week, phase III, double-blind study included patients aged ≥12 years with persistent asthma.

Efficacy and safety of beclomethasone dipropionate breath-actuated or metered-dose inhaler in pediatric patients with asthma.

Background: Breath-actuated inhalers (BAI) eliminate the need for hand-breath coordination and, therefore, simplify the delivery of inhaled medication.

Objective: To evaluate the efficacy and safety of beclomethasone dipropionate BAI and metered-dose inhaler (MDI) versus placebo in pediatric patients ages 4-11 years with persistent asthma.

Methods: In this double-blind, double-dummy, phase III study, 628 children with persistent asthma were randomly assigned (1:1:1:1:1) to twice-daily beclomethasone dipropionate (BAI 80 μg/day, BAI 160 μg/day, MDI 80 μg/day, or MDI 160 μg/day) or to placebo.

Small changes produce large gains in efficiency: a case study from Ross Memorial Hospital.

Healthcare is now more challenged to provide excellent care, while also increasing efficiency with more limited resources. The recent introduction of Ontario's funding reform challenges hospitals to increase the efficiency of specific procedures by providing funding based on patient volumes. The cataract surgery program at Ross Memorial Hospital, in Lindsay, Ontario, is an example of how a program designed a few years ago with a focus on patient care and efficiency managed to become substantially more efficient by introducing a series of small changes.

Quantifying monocyte infiltration in response to intradermal tetanus toxoid injection.

Aims: To characterize monocyte response in a delayed-type hypersensitivity reaction to intradermal tetanus toxoid (TT) injection.

Materials & Methods: Men with positive serum anti-tetanus titers were stratified by last TT vaccination. Subjects were administered three intradermal injections of TT and one saline control on the same side of the back.

Single- and multiple-dose pharmacokinetics and tolerability of telcagepant, an oral calcitonin gene-related peptide receptor antagonist, in adults.

Telcagepant is a novel, orally active, and selective calcitonin gene-related peptide receptor antagonist being developed for acute treatment of migraine with and without aura. Three separate clinical studies were conducted to evaluate the pharmacokinetics and tolerability of telcagepant following single oral doses in healthy young and elderly men and women and multiple oral doses in men. Telcagepant was rapidly absorbed with a time to maximum concentration of approximately 1.

Inhibition of capsaicin-induced increase in dermal blood flow by the oral CGRP receptor antagonist, telcagepant (MK-0974).

What Is Already Known About This Subject: * Calcitonin gene-related peptide (CGRP) was first described as a potent vasodilator. * CGRP is also increasingly recognized as a key player in the pathophysiology of migraine, and CGRP receptor antagonists potentially offer a new approach for treating migraine. * A novel pharmacodynamic assay to measure CGRP receptor antagonist activity non-invasively in humans has been developed, which involves measuring the increase in dermal blood flow induced by topical application of capsaicin on the forearm.

A thorough QTc study to assess the effect of sitagliptin, a DPP4 inhibitor, on ventricular repolarization in healthy subjects.

A randomized, double-blind, placebo-controlled, 4-period crossover study was performed with a single oral dose of sitagliptin (100 mg, 800 mg), moxifloxacin (400 mg), and placebo in order to provide a rigorous assessment of the effect of sitagliptin on ventricular repolarization based on the ICH E14 guidance. The clinical dose of sitagliptin 100 mg was not associated with an increase in QTc interval, corrected using the Fridericia correction (QTcf), at any time point. The supratherapeutic 800-mg dose of sitagliptin was generally well tolerated and was associated with minimal, clinically insignificant prolongation of the QTcf interval at concentrations approximately 11-fold higher than maximal concentrations following the 100-mg clinical dose.

Safety, pharmacokinetics, and pharmacodynamics of single doses of LXR-623, a novel liver X-receptor agonist, in healthy participants.

Liver X-receptor (LXR) agonists have been postulated to enhance reverse cholesterol transport (RCT), a process believed to shuttle cholesterol from the periphery back to the liver. Enhancing RCT via the upregulation of cholesterol transporters such as the adenosine triphosphate-binding cassettes ABCA1 and ABCG1 could therefore inhibit the progression of atherosclerosis. LXR-623 is a synthetic ligand for LXRs alpha and beta that has shown promise in animal models of atherosclerosis.

Clinical use of a carbohydrate-restricted diet to treat the dyslipidemia of the metabolic syndrome.

Background: The metabolic syndrome is characterized by an atherogenic dyslipidemia identifiable using lipoprotein subclass analysis. This study assesses the effect of a carbohydrate-restricted diet on the dyslipidemia of the metabolic syndrome in a clinical setting.

Methods: This is a retrospective chart review of patients attending a preventive medicine clinic using lipoprotein subclass analysis (by NMR spectroscopy) to identify the atherogenic dyslipidemia.

Predicting tobacco sales in community pharmacies using population demographics and pharmacy type.

Objective: To determine whether the population demographics of the location of pharmacies were associated with tobacco sales in pharmacies, when controlling for pharmacy type.

Design: Retrospective analysis.

Setting: Iowa.

Pharmacokinetics of aprepitant after single and multiple oral doses in healthy volunteers.

Aprepitant is the first NK1 receptor antagonist approved for use with corticosteroids and 5HT3 receptor antagonists to prevent chemotherapy-induced nausea and vomiting (CINV). The effective dose to prevent CINV is a 125-mg capsule on day 1 followed by an 80-mg capsule on days 2 and 3. Study 1 evaluated the bioavailability of the capsules and estimated the effect of food.

Effect of impaired renal function and haemodialysis on the pharmacokinetics of aprepitant.

Background: The neurokinin NK(1)-receptor antagonist aprepitant has demonstrated efficacy in preventing highly emetogenic chemotherapy-induced nausea and vomiting.

Objective: The objective of the present study was to investigate the effects of impaired renal function on the pharmacokinetics and safety of aprepitant.

Subjects And Methods: A total of 32 patients and healthy subjects were evaluated in this open-label, two-part study.

Potential for interactions between caspofungin and nelfinavir or rifampin.

The potential for interactions between caspofungin and nelfinavir or rifampin was evaluated in two parallel-panel studies. In study A, healthy subjects received a 14-day course of caspofungin alone (50 mg administered intravenously [IV] once daily) (n = 10) or with nelfinavir (1,250 mg administered orally twice daily) (n = 9) or rifampin (600 mg administered orally once daily) (n = 10). In study B, 14 subjects received a 28-day course of rifampin (600 mg administered orally once daily), with caspofungin (50 mg administered IV once daily) coadministered on the last 14 days, and 12 subjects received a 14-day course of caspofungin alone (50 mg administered IV once daily).