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LABA safety

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https://www.readbyqxmd.com/read/28961020/once-daily-fluticasone-furoate-vilanterol-versus-twice-daily-fluticasone-propionate-salmeterol-in-patients-with-asthma-well-controlled-on-ics-laba
#1
David Bernstein, Leslie Andersen, Richard Forth, Loretta Jacques, Louisa Yates
OBJECTIVE: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 μg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 μg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β2 agonist (ICS/LABA). METHODS: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 μg for 24 weeks...
September 29, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/28910559/the-impact-of-fda-regulatory-activities-on-incident-dispensing-of-laba-containing-medication-2005-2011
#2
Meghan A Baker, Melissa G Butler, Sally Seymour, Fang Zhang, Yute Wu, Ann Chen Wu, Mark S Levenson, Pingsheng Wu, Aarthi Iyer, Sengwee Toh, Solomon Iyasu, Esther H Zhou
OBJECTIVE: Evidence of safety issues associated with long-acting beta2-agonist (LABA) treatment has led to multiple regulatory activities by the U.S. Food and Drug Administration (FDA) on this class of medications. This study describes the impact of the regulatory activities on incident LABA-containing medication dispensing. METHODS: A monthly rolling cohort of asthma patients who were eligible to initiate a LABA-containing product was created in the Mini-Sentinel Distributed Database between January 2005 and June 2011...
September 14, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/28891349/next-generation-beta-adrenoreceptor-agonists-for-the-treatment-of-asthma
#3
Ernesto Crisafulli, Annalisa Frizzelli, Alberto Fantin, Alessandra Manco, Angelo Mangia, Giovanna Pisi, Valentina Fainardi, Veronica Alfieri, Marina Aiello, Giuseppina Bertorelli, Alfredo Chetta
A fixed-dose inhalation of a long-acting β-agonist (LABA) and inhaled corticosteroids (ICS) is commonly recommended for moderate to severe asthmatic patients not adequately controlled by an ICS only. In order to improve the patients' adherence and the control of disease there is a noteworthy interest for the next generation inhaled β adrenoreceptor agonists maintaining an over 24 hours bronchodilatation and used once-daily (ultra-LABAs). This review focuses on the currently available evidences on the clinical role of any single ultra-LABAs in the treatment of asthmatic patients...
October 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28890299/comparison-of-fluticasone-formoterol-with-budesonide-formoterol-pmdi-in-adults-with-moderate-to-severe-persistent-asthma-results-from-a-12-week-randomized-controlled-trial
#4
Akash Balki, S Balamurugan, Suhas Bardapurkar, Sonia Dalal, Ajeet Singh, B P Singh, Abhijit Vaidya, Jaideep A Gogtay
BACKGROUND: Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo(®)) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks...
September 7, 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28868931/emerging-inhaled-long-acting-beta-2-adrenoceptor-agonists-for-the-treatment-of-copd
#5
REVIEW
Thomas J Monaco, Nicola A Hanania
Chronic obstructive pulmonary disease (COPD), characterized by persistent and partially reversible airflow obstruction, is a leading cause of morbidity and mortality worldwide. Long-acting inhaled bronchodilators form the backbone for the maintenance therapy for this disease. The ultra-long-acting β2-agonists (ultra-LABAs) represent novel pharmacologic agents with interesting potential benefits as stand-alone therapy or in combination with other therapies for the treatment of COPD. Areas covered: In this review, we will focus newly developed ultra-LABAs, describing currently available evidence of their clinical effect and safety, their comparison relative to older long-acting β2-agonists, and their potential niche in the maintenance treatment of COPD...
September 2017: Expert Opinion on Emerging Drugs
https://www.readbyqxmd.com/read/28793336/a-systematic-review-of-adverse-drug-events-associated-with-administration-of-common-asthma-medications-in-children
#6
REVIEW
James S Leung, David W Johnson, Arissa J Sperou, Jennifer Crotts, Erik Saude, Lisa Hartling, Antonia Stang
OBJECTIVE: To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications. METHODS: Following PRISMA guidelines, we systematically searched six bibliographic databases between January 1991 and January 2017. Study eligibility, data extraction and quality assessment were independently completed and verified by two reviewers. We included randomized control trials (RCT), case-control, cohort, or quasi-experimental studies where the primary objective was identifying ADE in children 1 month- 18 years old exposed to commercial asthma medications...
2017: PloS One
https://www.readbyqxmd.com/read/28729041/pharmacological-preclinical-characterization-of-las190792-a-novel-inhaled-bifunctional-muscarinic-receptor-antagonist-%C3%AE-2-adrenoceptor-agonist-maba-molecule
#7
Mònica Aparici, Carla Carcasona, Israel Ramos, José Luís Montero, José Luís Ortiz, Julio Cortijo, Carlos Puig, Dolors Vilella, Chris Doe, Amadeu Gavaldà, Montserrat Miralpeix
LAS190792 is a novel muscarinic antagonist and β2-adrenoceptor agonist in development for chronic respiratory diseases. This study investigated the pharmacological profile of LAS190792 in comparison to batefenterol, tiotropium, indacaterol and olodaterol. LAS190792 is potent at the human M3 receptor (pIC50: 8.8 in binding assays). It is selective for the β2-adrenoceptor over the β1-and β3-adrenoceptor, and shows a functional potency in a similar range to batefenterol and LABA compounds (pEC50 in spontaneous tone isolated trachea: 9...
October 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28720132/efficacy-and-safety-of-direct-switch-to-indacaterol-glycopyrronium-in-patients-with-moderate-copd-the-crystal-open-label-randomised-trial
#8
Claus F Vogelmeier, Mina Gaga, Maryam Aalamian-Mattheis, Timm Greulich, Jose M Marin, Walter Castellani, Vincent Ninane, Stephen Lane, Xavier Nunez, Francesco Patalano, Andreas Clemens, Konstantinos Kostikas
BACKGROUND: Dual bronchodilation combining a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) is the preferred choice of treatment recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines for the management of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The once-daily (q.d.) fixed-dose combination (FDC) of LABA, indacaterol 110 μg and LAMA, glycopyrronium 50 μg (IND/GLY 110/50 μg q...
July 18, 2017: Respiratory Research
https://www.readbyqxmd.com/read/28677404/risk-of-cardiovascular-and-cerebrovascular-events-in-copd-patients-treated-with-long-acting-%C3%AE-2-agonist-combined-with-a-long-acting-muscarinic-or-inhaled-corticosteroid
#9
Jennifer C Samp, Min J Joo, Glen T Schumock, Gregory S Calip, A Simon Pickard, Todd A Lee
BACKGROUND: The recent approval of several fixed-dose combination long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) products has increased the use of dual bronchodilators in the treatment of chronic obstructive pulmonary disease (COPD). Understanding the comparative safety of this combination is important for informing treatment decisions. OBJECTIVE: To compare the risk of cardiovascular and cerebrovascular (CCV) events associated with LABA/LAMA compared with a combination of LABA and inhaled corticosteroid (ICS)...
November 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28677351/positioning-of-long-acting-muscarinic-antagonists-in-the-management-of-asthma
#10
REVIEW
René Aalbers, Hae Sim Park
Despite a range of efficacious therapies for asthma, including inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA), a significant proportion of patients have poor asthma control and retain a risk of future worsening of their symptoms. Long-acting muscarinic antagonist (LAMA) bronchodilators offer a well-tolerated, efficacious, and cost-effective add-on to a patient's treatment. Of the LAMAs currently under investigation or available for the treatment of asthma, evidence from a comprehensive clinical trial program in adults and children shows that once-daily treatment with tiotropium provides benefits for patients with uncontrolled asthma despite the use of ICS and LABAs...
September 2017: Allergy, Asthma & Immunology Research
https://www.readbyqxmd.com/read/28654201/long-acting-beta2-agonists-versus-long-acting-muscarinic-antagonists-in-patients-with-stable-copd-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#11
REVIEW
Wang-Chun Chen, Chi-Hsien Huang, Chau-Chyun Sheu, Inn-Wen Chong, Kuo-An Chu, Yung-Che Chen, Jong-Rung Tsai, Cheng-Hung Lee, Yu-Feng Wei
Several long-acting bronchodilators have been developed and are widely used as first-line treatment in patients with stable chronic obstructive pulmonary disease (COPD). However, the initial choice of therapy is still uncertain. The aim of this study was to examine the clinical efficacy and safety of long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) in patients with stable COPD. We searched several databases and manufacturers' websites to identify relevant randomized clinical trials for meta-analysis...
June 27, 2017: Respirology: Official Journal of the Asian Pacific Society of Respirology
https://www.readbyqxmd.com/read/28651509/drivers-of-choice-of-resuscitation-fluid-in-the-intensive-care-unit-a-discrete-choice-experiment
#12
COMPARATIVE STUDY
Colman B Taylor, Naomi E Hammond, Tracey-Lea Laba, Nicola Watts, Kelly Thompson, Manoj Saxena, Sharon Micallef, Simon Finfer, John Myburgh
OBJECTIVE: To understand the fundamental drivers, and their relative importance, of doctors' and nurses' choice of resuscitation fluid in critically ill patients in Australia and New Zealand. DESIGN: A discrete choice experiment (DCE) administered via an online survey. Respondents were presented with one of four randomly selected DCE choice sets, each including five patient scenarios. The respondent chose between two types of hypothetical resuscitation fluid. The fluid type was characterised by several attributes and each attribute had pre-specified levels...
June 2017: Critical Care and Resuscitation: Journal of the Australasian Academy of Critical Care Medicine
https://www.readbyqxmd.com/read/28644104/the-association-between-blood-eosinophil-count-and-benralizumab-efficacy-for-patients-with-severe-uncontrolled-asthma-subanalyses-of-the-phase-iii-sirocco-and-calima-studies
#13
Mitchell Goldman, Ian Hirsch, James G Zangrilli, Paul Newbold, Xiao Xu
OBJECTIVE: Benralizumab, an anti-eosinophilic monoclonal antibody, in combination with high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS/LABA), significantly reduced asthma exacerbations, improved lung function, and reduced symptoms for patients with severe, uncontrolled asthma with blood eosinophil counts ≥300 cells/μL in the Phase III SIROCCO and CALIMA studies. To understand the efficacy and safety of benralizumab for patients with eosinophil-driven disease with blood eosinophil counts lower than 300 cells/μL, we evaluated the effect of applying an eosinophil cutoff of ≥150 cells/μL...
July 19, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28536251/concurrent-use-of-long-acting-bronchodilators-in-copd-and-the-risk-of-adverse-cardiovascular-events
#14
Samy Suissa, Sophie Dell'Aniello, Pierre Ernst
The cardiovascular risk of concurrently using long-acting β2-agonists (LABAs) and anticholinergics (LAMAs) in COPD is uncertain. We assessed the comparative cardiovascular and cerebrovascular safety of adding a second long-acting bronchodilator in patients with COPD.We identified a cohort of COPD patients, new users of LABA or the LAMA tiotropium during 2002-2012, from the UK Clinical Practice Research Datalink. Using high-dimensional propensity scores, each patient adding a second bronchodilator was matched with a patient who remained on monotherapy...
May 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28491268/umeclidinium-in-chronic-obstructive-pulmonary-disease-latest-evidence-and-place-in-therapy
#15
REVIEW
Kesavan Suresh Babu, Jaymin Bhagwanji Morjaria
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality and health care expenditure throughout the world. COPD guidelines recommend the use of long-acting muscarinic antagonist (LAMA) either alone or in combination with a long-acting β2 agonist (LABA). For over 10 years, tiotropium was the only LAMA that was used in the management of COPD. Over the past few years, various new drugs have been identified that act on the muscarinic receptors and β2 receptors. Umeclidinium (Umec) is a new LAMA currently approved for use in patients with COPD either as monotherapy or in combination with vilanterol (Vil)...
April 2017: Therapeutic Advances in Chronic Disease
https://www.readbyqxmd.com/read/28417456/interventions-to-improve-adherence-to-inhaled-steroids-for-asthma
#16
REVIEW
Rebecca Normansell, Kayleigh M Kew, Elizabeth Stovold
BACKGROUND: Despite its proven efficacy in improving symptoms and reducing exacerbations, many patients with asthma are not fully adherent to their steroid inhaler. Suboptimal adherence leads to poorer clinical outcomes and increased health service utilisation, and has been identified as a contributing factor to a third of asthma deaths in the UK. Reasons for non-adherence vary, and a variety of interventions have been proposed to help people improve treatment adherence. OBJECTIVES: To assess the efficacy and safety of interventions intended to improve adherence to inhaled corticosteroids among people with asthma...
April 18, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28410560/role-of-long-acting-muscarinic-antagonist-long-acting-%C3%AE-2-agonist-therapy-in-chronic-obstructive-pulmonary-disease
#17
Sarah E Petite
OBJECTIVE: To compare the available literature regarding the use of long-acting muscarinic antagonist (LAMA)/long-acting β2 agonists (LABA) and inhaled corticosteroid (ICS)/LABA combination inhaler therapy in chronic obstructive pulmonary disease (COPD) maintenance therapy management. DATA SOURCES: A MEDLINE literature search from database inception to February 2017 was conducted using the search terms chronic obstructive pulmonary disease, adrenergic beta-agonist, muscarinic antagonist, and inhaled corticosteroid...
August 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28395575/safety-of-inhaled-long-acting-anti-muscarinic-agents-in-copd
#18
REVIEW
Nicola A Hanania, Suzanne C Lareau, Barbara P Yawn
Evidence-based guidelines recommend inhaled long-acting anti-muscarinic agents (LAMAs) as first-line maintenance therapy for symptomatic patients with COPD. Several LAMAs are now available for use either as monotherapy or in combination with other COPD medications, including long-acting β2-agonists (LABAs) or inhaled corticosteroids (ICS). The efficacy and long-term safety of these medications have been evaluated in multiple clinical trials and real-life studies. This review evaluates the evidence available on the safety of existing LAMAs alone or in combination with LABAs and ICS in patients with COPD...
June 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28389258/role-of-dual-bronchodilators-in-copd-a-review-of-the-current-evidence-for-indacaterol-glycopyrronium
#19
REVIEW
Joachim H Ficker, Klaus F Rabe, Tobias Welte
In this review, we summarize the rationale for combining long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD), and the evidence for the long-acting bronchodilator combination indacaterol/glycopyrronium (IND/GLY). Clinical practice guidelines generally recommend the use of long-acting bronchodilators in the treatment of patients with all severities of COPD, either as a first-choice or alternative-choice therapy. Combining classes of long-acting bronchodilators can result in superior improvements in lung function and clinical outcomes compared with bronchodilator monotherapy, as observed in studies of free combinations of long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs)...
August 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28383865/-spiolto-respimat%C3%A2-tiotropium-olodaterol-fixed-combination-for-therapy-of-chronic-obstructive-pulmonary-disease-copd
#20
REVIEW
D Cataldo
Chronic Obstructive Pulmonary Disease (COPD) is a chronic airway disease that can be prevented and treated. The recommendations for therapy include bronchodilators from two classes (LAMA (Long Acting Muscarinic Antagonists) and LABA (Long Acting Beta2 Agonists)). Spiolto Respimat® is a LAMA/LABA combination therapy and comprises tiotropium (Spiriva®) and olodaterol (a LABA). Clinical studies show that Spiolto Respimat® is able to improve lung function tests (Increased FEV1, decreased hyperinflation and residual volume) and quality of life as compared to tiotropium or olodaterol...
June 2016: Revue Médicale de Liège
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