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LABA safety

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https://www.readbyqxmd.com/read/29626716/pharmacological-mechanisms-leading-to-synergy-in-fixed-dose-dual-bronchodilator-therapy
#1
REVIEW
Luigino Calzetta, Maria Gabriella Matera, Mario Cazzola
Long-acting β2 adrenoceptor agonists (LABAs) in combination with long-acting muscarinic antagonists (LAMAs) can elicit functional and clinical benefits in chronic obstructive pulmonary disease (COPD). LABA/LAMA combinations synergistically relax human isolated airways at the level of the medium and small bronchi. LABAs and LAMAs both modulate the bronchial tone via different pathways localized at the level of presynaptic parasympathetic fibers and airway smooth muscle cells. The exact nature of the interactions between these pathways is not completely understood, but there is cross-talk at many levels in airway smooth muscle cells that is also regulated by the activity of calcium-activated potassium channels and protein tyrosine kinases...
April 4, 2018: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/29582249/fluticasone-propionate-salmeterol-mdpi-airduo-respiclick-%C3%A2-a-review-in-asthma
#2
Julia Paik, Lesley J Scott, Roy A Pleasants
The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick® ) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β2 -adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI...
March 26, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29567116/cardiovascular-safety-profile-of-a-fixed-dose-combination-of-glycopyrrolate-and-formoterol-fumarate-delivered-via-metered-dose-inhaler-using-co-suspension-delivery-technology
#3
Gary T Ferguson, Colin Reisner, James Pearle, Paolo DePetrillo, Andrea Maes, Ubaldo J Martin
BACKGROUND: Glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA), glycopyrrolate (GP), and the long-acting β2 -agonist (LABA), formoterol fumarate (FF), delivered via metered dose inhaler using innovative co-suspension delivery technology. Here we report the results of two studies that examined the cardiovascular safety of GFF MDI. METHODS: The thorough QT (TQT) study was a Phase I, randomized, double-blind, single-dose, crossover study to assess GFF MDI 18/9...
April 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29506504/a-phase-iib-randomized-chronic-dosing-incomplete-block-cross-over-study-of-glycopyrronium-delivered-via-metered-dose-inhaler-compared-with-a-placebo-and-an-active-control-in-patients-with-moderate-to-severe-copd
#4
Edward M Kerwin, Selwyn Spangenthal, Christine Kollar, Earl St Rose, Colin Reisner
BACKGROUND: Long-acting muscarinic antagonist (LAMA) and long-acting β2 -agonist (LABA) bronchodilators are key to the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). This Phase IIb study investigated the safety and efficacy of four doses of the LAMA glycopyrronium (GP) delivered using co-suspension delivery technology via metered dose inhaler (MDI). The study was part of a wider clinical trial program performed to determine the optimal dose of GP MDI, the LABA formoterol fumarate dihydrate (FF) MDI, and glycopyrronium/formoterol fumarate dihydrate (GFF) MDI fixed-dose combination to be taken forward into Phase III studies...
March 5, 2018: Respiratory Research
https://www.readbyqxmd.com/read/29505318/a-safety-comparison-of-laba-lama-vs-laba-ics-combination-therapy-for-copd
#5
Maria Gabriella Matera, Luigino Calzetta, Ermanno Puxeddu, Paola Rogliani, Mario Cazzola
LABA+LAMA and LABA+ICS combinations are key pharmacological approaches to the treatment of COPD. However, both combination types can induce adverse events (AEs). Areas covered: Current literature on LABA+LAMA and LABA+ICS combinations has been reviewed with a specific focus on their safety profile in the treatment of COPD. Expert opinion: Several meta-analyses have compared the pooled safety data from randomized clinical trials (RCTs) of LABA+LAMA combinations with LABA+ICS combinations. LABA+LAMA caused significantly less AEs and SAEs...
March 8, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29477448/effect-of-lung-deflation-with-indacaterol-plus-glycopyrronium-on-ventricular-filling-in-patients-with-hyperinflation-and-copd-claim-a-double-blind-randomised-crossover-placebo-controlled-single-centre-trial
#6
Jens M Hohlfeld, Jens Vogel-Claussen, Heike Biller, Dominik Berliner, Korbinian Berschneider, Hanns-Christian Tillmann, Simone Hiltl, Johann Bauersachs, Tobias Welte
BACKGROUND: Pulmonary hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with reduced biventricular end-diastolic volumes and increased morbidity and mortality. The combination of a long-acting β agonist (LABA) and a muscarinic antagonist (LAMA) is more effective in reducing hyperinflation than LABA-inhaled corticosteroid combination therapy but whether dual bronchodilation improves cardiac function is unknown. METHODS: We did a double-blind, randomised, two-period crossover, placebo-controlled, single-centre study (CLAIM) at the Fraunhofer Institute of Toxicology and Experimental Medicine (Hannover, Germany), a specialty clinic...
February 21, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29414831/-real-life-efficacy-and-safety-aspects-of-four-year-omalizumab-treatment-for-asthma
#7
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/food-and-drug-administration-mandated-trials-of-long-acting-%C3%AE-agonist-safety-in-asthma-bang-for-the-buck
#8
Samy Suissa, Elliot Israel, James Donohue, Scott Evans, James Kemp
No abstract text is available yet for this article.
April 15, 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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
(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
#16
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 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
#17
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
#18
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
#19
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
#20
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
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