Cardiovascular safety of mometasone/indacaterol and mometasone/indacaterol/glycopyrronium once-daily fixed-dose combinations in asthma: pooled analysis of phase 3 trials
“…The reduction in rescue medication use and daily asthma symptom scores and improvement in asthma quality-of-life questionnaire (AQLQ) scores were comparable between the IND/GLY/MF versus IND/MF or SAL/FLU groups [ 36 ]. Safety findings were consistent with the known safety profiles of LABA, LAMA, and ICS drug classes in asthma [ 36 , 39 ]. Fig.…”
Section: Clinical Overviewsupporting
confidence: 82%
“…4 c) [ 35 ]. The safety profile with IND/GLY/MF was comparable to that of SAL/FLU high-dose plus TIO [ 35 , 39 ].…”
A novel, once-daily (o.d.), fixed-dose combination (FDC) of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF), delivered by the inhaler Breezhaler Ò device, is the first long-acting beta2adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS) therapy to be approved for maintenance treatment of asthma in adults inadequately controlled on LABA/ICS. The approval of IND/GLY/MF in the European Union (EU) also included an optional electronic sensor and smartphone (or other suitable device) application, making it the first ''digital companion'' that can be prescribed with an asthma medication. As a result, the European Medicines Agency included this approval as one of the ''outstanding contributions
“…The reduction in rescue medication use and daily asthma symptom scores and improvement in asthma quality-of-life questionnaire (AQLQ) scores were comparable between the IND/GLY/MF versus IND/MF or SAL/FLU groups [ 36 ]. Safety findings were consistent with the known safety profiles of LABA, LAMA, and ICS drug classes in asthma [ 36 , 39 ]. Fig.…”
Section: Clinical Overviewsupporting
confidence: 82%
“…4 c) [ 35 ]. The safety profile with IND/GLY/MF was comparable to that of SAL/FLU high-dose plus TIO [ 35 , 39 ].…”
A novel, once-daily (o.d.), fixed-dose combination (FDC) of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF), delivered by the inhaler Breezhaler Ò device, is the first long-acting beta2adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS) therapy to be approved for maintenance treatment of asthma in adults inadequately controlled on LABA/ICS. The approval of IND/GLY/MF in the European Union (EU) also included an optional electronic sensor and smartphone (or other suitable device) application, making it the first ''digital companion'' that can be prescribed with an asthma medication. As a result, the European Medicines Agency included this approval as one of the ''outstanding contributions
“…A review of randomized controlled trials evaluating efficacy and safety of add‐on tiotropium in children and adolescents also supports the recently expanded indication by regulatory authorities in patients 6 years or older [51]. The efficacy and safety of fixed‐dose combination (FDC) triple therapy (ICS/LABA/LAMA) for GINA Steps 4 and 5 patients has been demonstrated by the recent clinical trials [52–60]. Therefore, the GINA guidelines have expanded the scope of asthma treatment since 2021 to include other LAMA molecules like glycopyrronium, umeclidinium, and FDC triple therapy for patients with asthma [1, 41, 54, 61, 62].…”
Section: Barriers To Achieving Optimum Asthma Controlmentioning
Asthma is a chronic respiratory disease with increasing global prevalence. It affects approximately 300 million people globally and more than a third of these patients have uncontrolled asthma. The burden of poorly controlled asthma is considerable both for the individuals and the society. The World Health Organization (WHO) estimates that, 455,000 people died from asthma worldwide in 2019, the majority in low and low‐middle‐income countries. This article highlights the unmet needs and burden of asthma in the Asia‐Pacific region where many patients have poorly controlled asthma despite advances in asthma care and treatment. A mismatch between patients’ (and physicians’) perception of asthma control and optimal asthma control as defined by the Global Initiative for Asthma (GINA) is a challenge in the real‐life management of many patients. Consequently, treatment adherence and optimization are affected. In many of these aspects, patients with asthma in the Asia‐Pacific region are comparatively worse than those from Europe and North America. In future, cooperation of all stakeholders is needed in improving awareness, education, and goal‐directed management of asthma with meaningful improvement in quality of life. This article draws attention to some of the important gaps in asthma management in the Asia‐Pacific region and suggests some measures to address these unmet needs.
“…с применением мометазона в виде монотерапии [26]. Аналогично при исследовании одного из наиболее современных ДДБА -олодатерола не установлено влияния на сердечно-сосудистые риски [27].…”
Introduction. According to modern data, bronchial asthma (BA) is an independent risk factor for the development of cardiac arrhythmias (CA), and the use of long-acting β2-agonists (LABA) in basic therapy may further increase the risks of CA.Aim. To study the structure and risk factors of cardiac arrhythmias in patients with bronchial asthma. Materials and methods. A retrospective study included 181 patients aged 69.4 ± 0.8 years, hospitalized for asthma, with the presence a CA in medical documentation.Results. Among BA patients with CA, supraventricular CA were found in 71.3% (129) patients, ventricular CA in 16.6% (30), combined CA in 12.2% (22). In 52.5% (95) patients, supraventricular extrasystole was detected, in 35.9% (65) – atrial fibrillation, in 28.7% (52) – ventricular extrasystole, in 1.1% (2) – paroxysmal supraventricular tachycardia, in 0.6% (1) – paroxysmal ventricular tachycardia. It was found that supraventricular CA was significantly more frequent among women (χ2 = 5.974, p = 0.05). The severity of BA and the level of control are not related to the type of observed CA (χ2 = 0.755, p = 0.685 and χ2 = 3.003, p = 0.557, respectively).Discussion. The use of a combination of ICS and LABA in basic BA therapy versus the use of ICS alone does not have a significant effect on the frequency and structure of cardiac arrhythmias (χ2 = 1.172, p = 0.556).Conclusion. In hospitalized BA patients, supraventricular cardiac arrhythmias are most often detected, among which supraventricular extrasystole and atrial fibrillation take the main place.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
