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Job Fm van Boven, Janwillem Wh Kocks, Maarten J Postma
PURPOSE: The fixed-dose dual bronchodilator combination (FDC) of tiotropium and olodaterol showed increased effectiveness regarding lung function and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with the use of its mono-components. Yet, while effectiveness and safety have been shown, the health economic implication of this treatment is still unknown. The aim of this study was to assess the cost-utility and budget impact of tiotropium-olodaterol FDC in patients with moderate to very severe COPD in the Netherlands...
2016: International Journal of Chronic Obstructive Pulmonary Disease
David M G Halpin, Marjan Kerkhof, Joan B Soriano, Helga Mikkelsen, David B Price
BACKGROUND: Management guidelines of chronic obstructive pulmonary disease (COPD) are mainly based on results of randomised controlled trials (RCTs), but some authors have suggested limited representativeness of patients included in these trials. No previous studies have applied the full range of selection criteria to a broad COPD patient population in a real-life setting. METHODS: We identified all RCTs of inhaled long-acting bronchodilator therapy, during 1999-2013, at ClinicalTrials...
2016: Respiratory Research
Masakazu Ichinose, Hiroyuki Taniguchi, Ayako Takizawa, Lars Grönke, Lazaro Loaiza, Florian Voß, Yihua Zhao, Yoshinosuke Fukuchi
BACKGROUND: The efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado(®) 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD. METHODS: In this Tonado(®) subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Carl Selya-Hammer, Nuria Gonzalez-Rojas Guix, Michael Baldwin, Andrew Ternouth, Marc Miravitlles, Maureen Rutten-van Mölken, Lucas M A Goosens, Nasuh Buyukkaramikli, Valentina Acciai
BACKGROUND: The objective of this study was to compare the cost-effectiveness of the fixed-dose combination (FDC) of tiotropium + olodaterol Respimat(®) FDC with tiotropium alone for patients with chronic obstructive pulmonary disease (COPD) in the Italian health care setting using a newly developed patient-level Markov model that reflects the current understanding of the disease. METHODS: While previously published models have largely been based around a cohort approach using a Markov structure and GOLD stage stratification, an individual-level Markov approach was selected for the new model...
October 2016: Therapeutic Advances in Respiratory Disease
François Maltais, Anne-Marie Kirsten, Alan Hamilton, Dorothy De Sousa, Florian Voß, Marc Decramer
BACKGROUND: Two replicate, double-blind, placebo-controlled, 6-week crossover studies assessed the effect of the once-daily long-acting β2-agonist olodaterol 5 μg and 10 μg on constant work-rate cycle endurance in patients with moderate to very severe chronic obstructive pulmonary disease. METHODS: Patients received placebo, olodaterol 5 μg once daily (QD) and olodaterol 10 μg QD in a randomised order for 6 weeks each, with a 2-week washout period in between...
2016: Respiratory Research
Wijdan H Ramadan, Wissam K Kabbara, Rosa M Abilmona
PURPOSE: Published data on the pharmacology, pharmacokinetics, efficacy, and safety of the once-daily, long-acting β2-agonist (LABA) olodaterol are reviewed. SUMMARY: Olodaterol (Striverdi Respimat, Boehringer Ingelheim), a LABA with high selectivity for β2-adrenergic receptors, is indicated for the treatment of chronic obstructive pulmonary disease (COPD); the recommended dose is 5 μg, to be delivered once daily via the Respimat inhaler. In 48- and 6-week Phase III clinical trials of olodaterol evaluating various lung function and symptomatic outcomes in patients with moderate to very severe COPD, olodaterol use was associated with significant improvements in spirometry outcomes, such as postbronchodilator forced expiratory volume in one second (FEV1), as well as dyspnea severity and quality-of-life measures...
August 1, 2016: American Journal of Health-system Pharmacy: AJHP
Dave Singh, Mina Gaga, Olaf Schmidt, Leif Bjermer, Lars Grönke, Florian Voß, Gary T Ferguson
BACKGROUND: As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and treatment history...
2016: Respiratory Research
Ichiro Kuwahira
Several new fixed-dose combination bronchodilators have been launched in the world, and 3 different types are now available in Japan. Assessing their efficacy relative to each other has not been performed yet. In the present manuscript, characteristics of glycopyrronium/indacaterol, umeclidinium/vilanterol and tiotropium/olodaterol were reviewed. In particular, changes in trough and peak forced expiratory volume in 1 second (FEV1), St George's Respiratory Questionnaire (SGRQ) total scores, and transitional dyspnea index (TDI) focal scores were reviewed in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
Hiroaki Kume
Long-acting β2-adrenergic receptor agonists (LABAs) and anticholinergics (LAMAs) are widely used clinically as therpy for COPD. Clinical reports have demonstrated that LABAs (salmeterol, formoterol, indacaterol, olodaterol, vilanterol) and LAMAs (tiotropium, glycopyrronium, umeclidinium, aclidinium) are useful to improving symptoms and lung function, and to reducing exacerbation and hospitarization. LABAs expect salmeterol are strong partial agonists, and LAMAs are non-specific antagonists. Ca2+ dynamics and Ca2+ sensitization contribute to relaxation of airway smooth muscle in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
Donald Banerji, Donald A Mahler, Nicola A Hanania
INTRODUCTION: Long-acting β2-agonists [LABAs] and long-acting muscarinic antagonists [LAMAs]) are primary therapies for chronic obstructive pulmonary disease (COPD). Despite improvements in lung function and patient-reported outcomes (PROs) with these therapies, there is room to optimize outcomes further. Combined use of LABAs and LAMAs is recommended when symptoms are not improved with a single agent, and LABA/LAMA fixed-dose combinations (FDCs) are at the forefront of drug development in COPD...
July 2016: Expert Review of Respiratory Medicine
Rüdiger Sauer, Michaela Hänsel, Roland Buhl, Roman A Rubin, Marcel Frey, Thomas Glaab
BACKGROUND: Maintaining and improving physical functioning is key to mitigating the cycle of deconditioning associated with chronic obstructive pulmonary disease (COPD). We evaluated the impact of free combination of the long-acting anticholinergic tiotropium plus the long-acting β2-agonist olodaterol on physical functioning in a real-world clinical setting. METHODS: In this open-label noninterventional study, Global initiative for chronic Obstructive Lung Disease (GOLD) B-D patients with COPD aged ≥40 years were treated for 4-6 weeks with either tiotropium 5 μg + olodaterol 5 μg (both via Respimat(®) inhaler) or tiotropium 18 μg (HandiHaler(®)) + olodaterol 5 μg (Respimat(®)) once daily...
2016: International Journal of Chronic Obstructive Pulmonary Disease
(no author information available yet)
No abstract text is available yet for this article.
April 2016: Prescrire International
Mario Cazzola, Barbara Rinaldi, Gabriella Lucà, Josuel Ora
INTRODUCTION: Long-acting β-agonist (LABA)/inhaled corticosteroid (ICS) combinations are still the mainstay of asthma therapy but there is a pressing need to increase adherence to the prescribed treatment achievable in general by reducing the dose frequency. Consequently, there is considerable interest within the pharmaceutical industry in the discovery of once-daily β2-agonists (ultra-LABAs) to be used as a part of a combination therapy for treating asthma. AREAS COVERED: The authors review the preclinical and clinical development of olodaterol, a new ultra-LABA characterized by an improved selectivity for β2-adrenoceptors and a rather high intrinsic efficacy profile, in asthma...
July 2016: Expert Opinion on Investigational Drugs
Jens Markus Borghardt, Benjamin Weber, Alexander Staab, Christina Kunz, Charlotte Kloft
AIMS: Olodaterol is an orally inhaled β2 -agonist for treatment of chronic obstructive pulmonary disease (COPD). The aims of this population pharmacokinetic (PK) analysis were: (1) to investigate systemic PK and thereby make inferences about pulmonary PK in asthmatic patients, COPD patients and healthy volunteers, and (2) to assess whether differences in pulmonary efficacy might be expected based on pulmonary PK characteristics. METHODS: Plasma and urine data after olodaterol inhalation were available from six clinical trials comprising 710 patients and healthy volunteers (single and multiple dosing)...
September 2016: British Journal of Clinical Pharmacology
Thierry Troosters, Jean Bourbeau, François Maltais, Nancy Leidy, Damijan Erzen, Dorothy De Sousa, Lawrence Korducki, Alan Hamilton
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with exercise limitation and physical inactivity, which are believed to have significant long-term negative health consequences for patients. While a number of COPD treatments and exercise training programmes increase exercise capacity, there is limited evidence for their effects on physical activity levels, with no clear association between exercise capacity and physical activity in clinical trials. Physical activity depends on a number of behaviour, environmental and physiological factors...
2016: BMJ Open
Christina Kunz, Doreen Luedtke, Anna Unseld, Alan Hamilton, Atef Halabi, Martina Wein, Stephan Formella
PURPOSE: In two trials, the influences of hepatic and renal impairment on the pharmacokinetics of olodaterol, a novel long-acting inhaled β2-agonist for treatment of COPD, were investigated. SUBJECTS AND METHODS: The first trial included eight subjects with mild hepatic function impairment (Child-Pugh A), eight subjects with moderate impairment (Child-Pugh B), and 16 matched healthy subjects with normal hepatic function. The second trial included eight subjects with severe renal impairment (creatinine clearance <30 mL·min(-1)) and 14 matched healthy subjects with normal renal function...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Jean Bourbeau, Kim L Lavoie, Maria Sedeno, Dorothy De Sousa, Damijan Erzen, Alan Hamilton, François Maltais, Thierry Troosters, Nancy Leidy
INTRODUCTION: Chronic obstructive pulmonary disease is generally progressive and associated with reduced physical activity. Both pharmacological therapy and exercise training can improve exercise capacity; however, these are often not sufficient to change the amount of daily physical activity a patient undertakes. Behaviour-change self-management programmes are designed to address this, including setting motivational goals and providing social support. We present and discuss the necessary methodological considerations when integrating behaviour-change interventions into a multicentre study...
2016: BMJ Open
Cristoforo Incorvaia, Marcello Montagni, Elena Makri, Gian Galeazzo Riario-Sforza, Erminia Ridolo
β2-agonists were introduced in the 1940s as bronchodilators to be used in obstructive respiratory diseases. Long-acting β2-agonists have been a mainstay of bronchodilating treatment for decades. Recently, agents extending their effect to 24 hours and thus allowing the once-daily administration were introduced, defined as very-long-acting β2-agonists. Olodaterol is a new very-long-acting β2-agonist that has been shown, in controlled trials, to improve lung function as well as clinical outcomes and quality of life...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Maria Gabriella Matera, Paola Rogliani, Luigino Calzetta, Mario Cazzola
Combining a long-acting β2-agonist (LABA) with a long-acting anti-muscarinic agent (LAMA) provides synergistic benefit on airway smooth muscle relaxation, which may have major implications for the use of LABA/LAMA combinations in the treatment of chronic obstructive pulmonary disease (COPD). There are four different approved LAMA/LABA fixed-dose combinations (FDCs)-glycopyrronium/indacaterol, umeclidinium/vilanterol, tiotropium/olodaterol, and aclidinium/formoterol-and another, glycopyrronium/formoterol, that is still under clinical development...
June 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Juan F Mosley, Lillian L Smith, Brittany N Dutton
Tiotropium bromide/olodaterol (Stiolto Respimat): once-daily combination therapy for the maintenance of COPD.
February 2016: P & T: a Peer-reviewed Journal for Formulary Management
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