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LABA safety

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https://www.readbyqxmd.com/read/29414831/-real-life-efficacy-and-safety-aspects-of-four-year-omalizumab-treatment-for-asthma
#1
Mona Al-Ahmad, Nermina Arifhodzic, Jasmina Nurkic, Ahmed Maher, Tito Rodriguez-Bouza, Nasser Al-Ahmed, Ali Sadek, Edin Jusufovic
OBJECTIVE: To evaluate the long-term efficacy and safety of omalizumab in asthma in a real-life setting. SUBJECTS AND METHODS: This was a 4-year observational study that included 65 patients treated with omalizumab during clinic visits; treatment response was rated as excellent, good and partial based on modified GETE (mGETE) scale. of emergency room visits (ERV), hospitalization, use of oral corticosteroids, inhaled corticosteroids/ long acting beta-agonist (ICS/LABA) dose, and short acting beta-agonist (SABA) rescue...
February 7, 2018: Medical Principles and Practice: International Journal of the Kuwait University, Health Science Centre
https://www.readbyqxmd.com/read/29357261/fda-mandated-trials-of-laba-safety-in-asthma-bang-for-the-buck
#2
Samy Suissa, Elliot Israel, James Donohue, Scott Evans, James Kemp
The safety of long-acting beta-agonists (LABA) to treat asthma has been a lingering issue for the last 25 years after two large randomized trials reported an increased incidence of asthma death with salmeterol. The current dilemma is whether this risk is also increased when LABAs are given with inhaled corticosteroids (ICS). To address this, the FDA required that manufacturers conduct five large randomized trials comparing ICS-LABA combinations to ICS alone on the incidence of major asthma outcomes. The three trials that have been published to date showed that the risk of a serious asthma-related event, including asthma-related death, intubation or hospitalization, was not increased with the addition of the LABA...
January 22, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29332144/long-acting-%C3%AE-2-agonists-in-asthma-enantioselective-safety-studies-are-needed
#3
Glenn A Jacobson, Sharanne Raidal, Morten Hostrup, Luigino Calzetta, Richard Wood-Baker, Mark O Farber, Clive P Page, E Haydn Walters
Long-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without ICS. LABAs clearly demonstrate effective bronchodilatation and steroid-sparing activity, but long-term treatment can lead to tolerance of their bronchodilator effects. There are also concerns with regard to the effects of LABAs on bronchial hyperresponsiveness (BHR), where long-term use is associated with increased BHR and loss of bronchoprotection...
January 13, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29279056/a-review-of-the-efficacy-and-safety-of-once-daily-tiotropium-respimat-2-5-micrograms-in-adults-and-adolescents-with-asthma
#4
Eli O Meltzer, William E Berger
BACKGROUND: Despite current guidelines, many patients with asthma remain symptomatic, particularly those intolerant of, unresponsive to, or uncontrolled by long-acting beta 2-agonists (LABAs). Tiotropium bromide, delivered through the Respimat soft-mist inhaler in 2 puffs of 1.25 micrograms each, is approved for the long-term, maintenance treatment of asthma in patients aged ≥6 years. OBJECTIVE: An overview of the use of once-daily tiotropium Respimat 2.5 micrograms in adults and adolescents with varying degrees of asthma severity...
January 6, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29206657/dual-bronchodilator-therapy-for-chronic-obstructive-pulmonary-disease-evidence-for-the-efficacy-and-safety-of-fixed-dose-combination-treatments-in-the-setting-of-recent-guideline-updates
#5
Steven D Deas, Nikhil Huprikar
PURPOSE OF REVIEW: Recent updates to the GOLD guidelines emphasize the use of combination LABA and LAMA bronchodilators for patients with chronic obstructive pulmonary disease with persistent dyspnea despite monotherapy or frequent exacerbations despite LAMA monotherapy. There are several commercially available LABA/LAMA fixed dose combination inhalers, which are likely to become the principle therapy for many patients with COPD. RECENT FINDINGS: In the last 4 years, there have been a number of large clinical trials evaluating the efficacy and safety of combined LAMA and LABA bronchodilators...
March 2018: Current Opinion in Pulmonary Medicine
https://www.readbyqxmd.com/read/29178871/efficacy-and-safety-of-tiotropium-and-olodaterol-in-copd-a-systematic-review-and-meta-analysis
#6
Marc Miravitlles, Gerard Urrutia, Alexander G Mathioudakis, Julio Ancochea
BACKGROUND: Long-acting bronchodilators are the cornerstone of pharmacologic treatment of COPD. The new combination of long-acting muscarinic antagonist (LAMA) tiotropium (TIO) and long acting beta-agonists (LABA) olodaterol (OLO) has been introduced as fist line therapy for COPD. This article analyses the evidence of efficacy and safety of the TIO/OLO combination. METHODS: A systematic review and metaanalysis of randomized controlled trials (RCT) with a period of treatment of at least 6 weeks, in patients with COPD confirmed by spirometry, comparing combined treatment with TIO/OLO (approved doses only), with any of the mono-components or any other active comparator administered as an inhalator...
November 25, 2017: Respiratory Research
https://www.readbyqxmd.com/read/29128192/efficacy-and-safety-of-benralizumab-in-japanese-patients-with-severe-uncontrolled-eosinophilic-asthma
#7
Ken Ohta, Mitsuru Adachi, Yuji Tohda, Tadashi Kamei, Motokazu Kato, J Mark Fitzgerald, Masayuki Takanuma, Tadahiro Kakuno, Nobuyuki Imai, Yanping Wu, Magnus Aurivillius, Mitchell Goldman
BACKGROUND: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial. METHODS: CALIMA was a randomised, controlled trial of 1306 patients (aged 12-75 years; registered at ClinicalTrials.gov: NCT01914757) with severe asthma uncontrolled by medium- to high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS/LABA)...
November 8, 2017: Allergology International: Official Journal of the Japanese Society of Allergology
https://www.readbyqxmd.com/read/29120273/triple-therapy-in-copd-what-we-know-and-what-we-don-t
#8
Peter M A Calverley, Helgo Magnussen, Marc Miravitlles, Jadwiga A Wedzicha
Triple inhaled therapy for chronic obstructive pulmonary disease (COPD) consists of an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) taken in combination. Triple therapy is recommended by the Global initiative for Chronic Obstructive Lung Disease (GOLD) for patients who experience recurrent exacerbations despite treatment with either a dual bronchodilator (preferred initial therapy) or LABA/ICS combination (alternative initial therapy). Although there is evidence for the greater efficacy of triple therapy compared with LABA/ICS and LAMA monotherapy with regards to improved lung function, health status, and exacerbation rate, the efficacy of triple therapy when compared with dual bronchodilation (LABA/LAMA) is as yet unknown...
December 2017: COPD
https://www.readbyqxmd.com/read/29108533/a-review-of-the-efficacy-and-safety-of-once-daily-tiotropium-respimat-2-5-micrograms-in-adults-and-adolescents-with-asthma
#9
(no author information available yet)
BACKGROUND: Despite current guidelines, many patients with asthma remain symptomatic, particularly those intolerant of,unresponsive to, or uncontrolled by long-acting beta 2-agonists (LABAs). Tiotropium bromide, delivered through the Respimatsoft-mist inhaler in 2 puffs of 1.25 micrograms each, is approved for the long-term, maintenance treatment of asthma in patients aged greater than or equal to 6 years. OBJECTIVE: An overview of the use of once-daily tiotropium Respimat 2...
November 6, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29094315/comparative-efficacy-of-once-daily-umeclidinium-vilanterol-and-tiotropium-olodaterol-therapy-in-symptomatic-chronic-obstructive-pulmonary-disease-a-randomized-study
#10
Gregory J Feldman, Ana R Sousa, David A Lipson, Lee Tombs, Neil Barnes, John H Riley, Sadhana Patel, Ian Naya, Chris Compton, Bernardino Alcázar Navarrete
INTRODUCTION: We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD. METHODS: This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy...
November 1, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29071080/description-of-the-protocol-for-the-practical-study-a-randomised-controlled-trial-of-the-efficacy-and-safety-of-ics-laba-reliever-therapy-in-asthma
#11
James Fingleton, Jo Hardy, Christina Baggott, Janine Pilcher, Andrew Corin, Robert J Hancox, Matire Harwood, Mark Holliday, Helen K Reddel, Philippa Shirtcliffe, Suzanne Snively, Mark Weatherall, Richard Beasley
INTRODUCTION: In adult asthma, combination inhaled corticosteroid (ICS)/fast-onset long-acting beta agonist (LABA) used solely as reliever therapy may represent an effective and safe alternative to ICS maintenance and short-acting beta agonist (SABA) reliever therapy. OBJECTIVE: To compare the efficacy and safety of ICS/fast-onset LABA reliever therapy with ICS maintenance and SABA reliever therapy in adults with asthma. METHODS AND ANALYSIS: A 52-week, open-label, parallel group, multicentre, phase III randomised controlled trial with 1:1 randomisation to either budesonide/formoterol Turbuhaler 200/6 µg, one actuation as required for symptom relief, or budesonide Turbuhaler 200 µg, one actuation twice daily and terbutaline Turbuhaler 250 µg, two actuations as required for symptom relief...
2017: BMJ Open Respiratory Research
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
#12
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
#13
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
#14
REVIEW
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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