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LABA safety

Ping Wei, Jia-Wei Yang, Hai-Wen Lu, Bei Mao, Wen-Lan Yang, Jin-Fu Xu
BACKGROUND AND OBJECTIVE: There is presently no clear evidence on the effect of combined treatment for non-cystic fibrosis (non-CF) bronchiectasis with inhaled corticosteroid (ICS) and long-acting β2-adrenergic agonist (LABA). The objective of this study is to assess the efficacy and safety of salmeterol-fluticasone combined inhaled therapy for non-CF bronchiectasis with airflow limitation. METHODS: An observational study was performed in 120 non-CF bronchiectasis patients diagnosed by high-resolution computed tomography (HRCT) scanning of the chest...
October 2016: Medicine (Baltimore)
Manon Belhassen, Anjan Nibber, Eric Van Ganse, Dermot Ryan, Carole Langlois, Francis Appiagyei, Derek Skinner, Laurent Laforest, Joan B Soriano, David Price
Against recurrent controversies around the safety of short- and long-acting β2-agonists (SABA and LABA), and the National Review of Asthma Deaths inquiry in the United Kingdom, we investigated the prevalence of inappropriate therapy in asthma. Our study aimed to determine the prevalence of inappropriate use of asthma therapy in the United Kingdom and in France. Two interval, parallel, population-based cohorts (2007 and 2013) were developed in each country by using the UK OPCRD and the French EGB databases...
October 13, 2016: NPJ Primary Care Respiratory Medicine
Stefan Andreas, Christer Janson, Maarten van den Berge, Lies Lahousse
SUMMIT supports the efficiency and cardiovascular safety of LABA and ICS in COPD patients at cardiovascular risk
April 2016: ERJ Open Research
Nanshan Zhong, Changzheng Wang, Xiangdong Zhou, Nuofu Zhang, Michael Humphries, Linda Wang, Francesco Patalano, Donald Banerji
Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries, including the EU, Japan, Australia and Switzerland and the US. The LANTERN study evaluated the efficacy of IND/GLY compared with inhaled long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) or salmeterol/fluticasone (SFC) in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. Here we present the efficacy and safety of IND/GLY versus SFC in the Chinese cohort from the LANTERN study...
August 11, 2016: COPD
David M G Halpin
Despite current therapeutic approaches asthma remains uncontrolled in a significant proportion of patients. Short-acting anticholinergic bronchodilators have a very long history of use in asthma, and recent data confirms the importance of acetylcholine as both a bronchoconstrictor and as a regulator of inflammation and remodeling in the lungs. Data from a comprehensive clinical trial programme, as well as use in primary care, show the efficacy and safety of tiotropium in adults with mild to moderate asthma when it is added to ICS and in severe asthma when it is added to high doses of ICS plus LABA, as well as in adolescents...
2016: World Allergy Organization Journal
Christian Vogelberg
Asthma is a chronic inflammatory airway disease, and its treatment is frequently challenging despite detailed national and international guidelines. While basic anti-inflammatory therapy usually consists of inhaled corticosteroids in doses adapted to the asthma severity, add-on treatment with bronchodilators is essential in more severe asthma. Only recently, the long-acting anticholinergic tiotropium was introduced into the GINA guidelines. This review reports on the studies that have been performed with tiotropium in adult asthmatic patients...
September 9, 2016: Therapeutic Advances in Respiratory Disease
Eugene R Bleecker, J Mark FitzGerald, Pascal Chanez, Alberto Papi, Steven F Weinstein, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Magnus Aurivillius, Viktoria Werkström, Mitchell Goldman
BACKGROUND: Eosinophilia is associated with worsening asthma severity and decreased lung function, with increased exacerbation frequency. We assessed the safety and efficacy of benralizumab, a monoclonal antibody against interleukin-5 receptor α that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity, for patients with severe, uncontrolled asthma with eosinophilia. METHODS: We did a randomised, double-blind, parallel-group, placebo-controlled phase 3 study at 374 sites in 17 countries...
September 2, 2016: Lancet
J Mark FitzGerald, Eugene R Bleecker, Parameswaran Nair, Stephanie Korn, Ken Ohta, Marek Lommatzsch, Gary T Ferguson, William W Busse, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Viktoria Werkström, Magnus Aurivillius, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, afucosylated, anti-interleukin-5 receptor α monoclonal antibody that induces direct, rapid, and nearly complete depletion of eosinophils. We aimed to assess the efficacy and safety of benralizumab as add-on therapy for patients with severe, uncontrolled asthma and elevated blood eosinophil counts. METHODS: In this randomised, double-blind, parallel-group, placebo-controlled, phase 3 study (CALIMA) undertaken at 303 sites in 11 countries, we enrolled patients aged 12-75 years with severe asthma uncontrolled by medium-dosage to high-dosage inhaled corticosteroids plus long-acting β₂-agonists (ICS plus LABA) and a history of two or more exacerbations in the previous year...
September 5, 2016: Lancet
Fernando J Martinez, Klaus F Rabe, Sanjay Sethi, Emilio Pizzichini, Andrew McIvor, Antonio Anzueto, Vijay K T Alagappan, Shahid Siddiqui, Ludmyla Rekeda, Christopher J Miller, Sofia Zetterstrand, Colin Reisner, Stephen I Rennard
RATIONALE: Moderate and severe exacerbations are incompletely prevented by maximal inhalation therapy in patients with severe chronic obstructive pulmonary disease. OBJECTIVES: To determine whether roflumilast reduces moderate and/or severe chronic obstructive pulmonary disease exacerbations in patients at risk for exacerbations despite treatment with inhaled corticosteroid/long-acting β2-agonist with or without a long-acting muscarinic antagonist (LAMA). METHODS: In this 52-week, phase 4, double-blind, placebo-controlled RE(2)SPOND (Roflumilast Effect on Exacerbations in Patients on Dual [LABA/ICS] Therapy) trial (NCT01443845), participants aged 40 years or older with severe/very severe chronic obstructive pulmonary disease, chronic bronchitis, two or more exacerbations and/or hospitalizations in the previous year, and receiving inhaled corticosteroid/long-acting β2-agonist with or without LAMA daily for 3 or more months were equally randomized to once-daily roflumilast, 500 μg (n = 1,178), or placebo (n = 1,176)...
September 1, 2016: American Journal of Respiratory and Critical Care Medicine
Kerry Dwan, Stephen J Milan, Lynne Bax, Nicola Walters, Colin Powell
BACKGROUND: Vilanterol (VI) is a long-acting beta2-agonist (LABA) that binds to the beta2-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy...
September 1, 2016: Cochrane Database of Systematic Reviews
David A Stempel, Stanley J Szefler, Søren Pedersen, Robert S Zeiger, Anne M Yeakey, Laurie A Lee, Andrew H Liu, Herman Mitchell, Kenneth M Kral, Ibrahim H Raphiou, Barbara A Prillaman, Kathleen S Buaron, Suyong Yun Kirby, Steven J Pascoe
BACKGROUND: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. METHODS: We randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks...
September 1, 2016: New England Journal of Medicine
Stephen I Rennard, Fernando J Martinez, Klaus F Rabe, Sanjay Sethi, Emilio Pizzichini, Andrew McIvor, Shahid Siddiqui, Antonio Anzueto, Haiyuan Zhu
BACKGROUND: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein. METHODS: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Samy Suissa, Sophie Dellaniello, Pierre Ernst
BACKGROUND: Long-acting bronchodilators, including long-acting beta2-agonists (LABA) and the anticholinergic tiotropium, are recommended as initial maintenance therapy in COPD. Studies to date have been limited in size and reported ambivalent results on the comparative risk of cardiovascular, cerebrovascular and pulmonary adverse events between these two long-acting bronchodilators. Moreover, little information is available for the period when treatment is first initiated, a time when subjects may be especially at risk...
August 20, 2016: Chest
Elin T G Kersten, Gerard H Koppelman, Bernard J Thio
Beta2-adrenoreceptor agonists (β2-agonists) are extensively used in the treatment of childhood asthma. However, there have been concerns regarding their adverse effects and safety. In 2005, the FDA commissioned a "Black Box Warning" communicating the potential for an increased risk for serious asthma exacerbations or asthma related deaths, with the regular use of LABAs. In a meta-analysis of controlled clinical trials, the incidence of severe adverse events appeared to be highest in the 4-11 year age group...
June 16, 2016: Paediatric Respiratory Reviews
(no author information available yet)
▼Canagliflozin and risk of lower limb amputation ● Antidepressants and young people ● Biological interventions for fatigue in RA ● Body shape in early and midlife linked to mortality ● COPD: LABA plus LAMA versus LABA plus ICS ● Safety warning for Nexplanon (etonogesterel) contraceptive implants ● Incorporating long-term prognosis into the care of older adults ● Impact of moderate-to-vigorous physical activity on cancer risk.
August 2016: Drug and Therapeutics Bulletin
J A Quintano Jiménez, L Ginel Mendoza, L M Entrenas Costa, J Polo García
The fixed-dose combination fluticasone propionate/formoterol (FPF) is a novel combination of a widely known and used inhaled glucocorticoid (IGC) and a long-acting β2-adrenergic agonist (LABA), available for the first time in a single device. This fixed-dose combination of FPF has a demonstrated efficacy and safety profile in clinical trials compared with its individual components and other fixed-dose combinations of IGC/LABA and is indicated for the treatment of persistent asthma in adults and adolescents...
February 2016: Semergen
Paolo Montuschi, Mario Malerba, Giuseppe Macis, Nadia Mores, Giuseppe Santini
Combining individual drugs in a single inhaler is the most convenient way to deliver triple therapy. A long-acting muscarinic receptor antagonist (LAMA) added to an inhaled corticosteroid (ICS)/long-acting β2-adrenoceptor agonist (LABA) fixed-dose combination (FDC) can improve efficacy of pharmacological treatment of patients with chronic obstructive pulmonary disease (COPD). New inhaled ICS/LABA/LAMA FDCs, including fluticasone furoate/vilanterol/umeclidinium, budesonide/formoterol/glycopyrronium and beclometasone/formoterol/glycopyrronium, are in Phase III of clinical development for COPD...
July 21, 2016: Drug Discovery Today
Alessandro Zanforlin, Angelo G Corsico, Fabiano DI Marco, Vincenzo Patella, Nicola Scichilone
Asthma is the most commonly occurring respiratory complication during pregnancy, and is associated with a wide range of adverse maternal and perinatal outcomes. However, there is strong evidence that an adequate control of asthma can improve the health of both mothers and their babies. Despite the well-known risks of poorly-controlled asthma during pregnancy, a large proportion of women have sub-optimal asthma control, due to concerns surrounding risks related to pharmacological agents and uncertainties regarding the effectiveness and safety of different management strategies...
February 2016: Minerva Medica
Steven J Pascoe, David A Lipson, Nicholas Locantore, Helen Barnacle, Noushin Brealey, Rajat Mohindra, Mark T Dransfield, Ian Pavord, Neil Barnes
Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting β2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period...
August 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Jiangtao Lin, Huaping Tang, Ping Chen, Haoyan Wang, Mi-Kyeong Kim, Jodie Crawford, Loretta Jacques, Sally Stone
BACKGROUND: Response to inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combinations varies across ethnic groups. OBJECTIVE: To investigate the efficacy and safety of the ICS/LABA combination fluticasone furoate/vilanterol (FF/VI) 100/25 μg in Asian patients with asthma. METHODS: A randomized (1:1), 12-week, double-blind, placebo-controlled, parallel group, multicenter phase III study of once-daily FF/VI 100/25 μg versus placebo in patients of Asian ancestry ages ≥12 years with asthma, uncontrolled on a low- to mid-strength ICS or low-dose ICS/LABA...
July 2016: Allergy and Asthma Proceedings:
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