A new user cohort study comparing the safety of long-acting inhaled bronchodilators in COPD

Jara, Michele; Wentworth, Charles; Lanes, Stephan

doi:10.1136/bmjopen-2012-000841

Cited by 29 publications

(36 citation statements)

References 36 publications

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“…Ezekre az ipratropiumnál leírtak érvényesek. Jara viszont nemcsak a meglévő szívbetegségeket, szívgyógyszereket közli, hanem a dohányzást és a spirográfi át is, sőt a vesefunkciót is fi gyelembe vette [10]. Anyagában a tiotropium mellett az angina és a szívinfarktus szaporodott, az összmortali-tás csökkent, az arrhythmia és a szívelégtelenség válto-zatlan maradt.…”

Section: Tiotropium Handihalerunclassified

Van-e cardiovascularis mellékhatásuk az inhalációs antikolinerg szereknek?

Nagy¹

2015

Orvosi Hetilap

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Az összefoglaló célja az inhalációs antikolinerg szerek cardiovascularis veszélyének tárgyalása krónikus obstruktív tü-dőbetegségben. A tiotropium-használat adatainak néhány metaanalízise felvetette ilyen mellékhatások (arrhythmia, angina, szívinfarktus stb.) fokozott lehetőségét. Az összefoglaló áttekinti a retrospektív adatbázis-feldolgozásokat, a randomizált kontrollcsoportos vizsgálatokat és a klinikai vizsgálatok metaanalíziseit. Az adatbázis-vizsgálatok eredményei inkonzisztensek. A legtöbb klinikai vizsgálatban a cardiovascularis mellékhatások incidenciája azonos volt az aktív kezelésű és a placebocsoportban, jellemzően azoknál a betegeknél is, akik előzőleg cardiovascularis betegségben szenvedtek. A metaanalízisekben kevés a bizonyíték vagy egyáltalán nincs arra nézve, hogy összefüggés van az antikolinergek és a cardiovascularis tünetek között. A szerző áttekinti a humán szív kolinergreceptor-altípusait és funkcióját, a szívműködés ezen receptorok útján történő autonóm szabályozását, ezek lehetséges szerepét és az inhalált antikolinerg szerek farmakokinetikai tulajdonságait. Megállapítja, hogy nincs bizonyíték az inhalációs antikolinerg szerek fokozott cardiovascularis ártalmára. Orv. Hetil., 2015, 156(31), 1246-1252. Kulcsszavak: krónikus obstruktív tüdőbetegség, inhalációs antikolinerg szerek, cardiovascularis szövődmények Are there cardiovascular adverse effects of inhaled anticholinergics?The purpose of this review is to discuss the cardiovascular risk associated with inhaled anticholinergics in chronic obstructive pulmonary disease. Several meta-analyses of data for tiotropium raised the possibility of an increased risk for arrhythmia, angina, myocardial infarction, etc. This review includes the data of retrospective studies of databases using databases, randomized controlled trials, and meta-analyses of clinical trials. The conclusions of studies were inconsistent. In most clinical trials the incidence of cardiovascular adverse events was similar in active treatment and placebo groups, especially in patients with previous cardiovascular diseases. Considering meta-analyses, there is little, if any, evidence for the association between anticholinergics and the development of cardiovascular symptoms. The author discusses the presence and function of cholinergic receptor subtypes in human heart, and cardiac functions controlled by the autonomic nervous system via these receptors, their possible role, and pharmacokinetic properties of inhaled anticholinergics. The author concludes that it is not possible to fi nd evidence of increased cardiovascular harm of inhaled anticholinergics.Keywords: chronic obstructive pulmonary disease, inhaled anticholinergics, adverse cardiovascular events Nagy, L. B. [Are there cardiovascular adverse effects of inhaled anticholinergics?]. Orv. Hetil., 2015, 156(31), 1246-1252. (Beérkezett: 2015 elfogadva: 2015. május 18.) Rövidítések cAMP = ciklikus adenozin-monofoszfát; COPD = krónikus obstruktív tüdőbetegség; FEV1 = forszírozott másodpercvolu-men; ISZB = ischaemiás s...

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Section: Tiotropium Handihalerunclassified

Van-e cardiovascularis mellékhatásuk az inhalációs antikolinerg szereknek?

Nagy¹

2015

Orvosi Hetilap

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“…A recent study investigated the medical records database of general practitioners in the UK in terms of new users of long-acting anticholinergic therapy (tiotropium HandiHaler ® , Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA) (n = 4767) in comparison with new users of LABA monotherapy (n = 6073) 39. They found that more cardiovascular events occurred when using tiotropium compared with LABA for stroke (HR, 1.49; 95% CI 0.91–2.15), myocardial infarction (HR, 1.38, 95% CI 0.88–2.15), and angina (HR 1.26; 95% CI 0.72–2.21) compared with LABA.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Ten years of tiotropium: clinical impact and patient perspectives

Yohannes¹,

Connolly²,

Hanania³

2013

COPD

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Tiotropium bromide is an anticholinergic agent that has gained worldwide acceptance as a first-line, once daily maintenance therapy for patients with moderate-to-severe chronic obstructive pulmonary disease. The purpose of this review is to synthesize the evidence base in the past 10 years on the development of tiotropium and its efficacy compared to other able interventions such as long-acting beta agonists (LABAs), as well as to assess its safety profile and its effects on health-related outcomes in patients with COPD. Treatment with tiotropium bromide has generally improved patients’ health-related quality of life, reduced the number of patients suffering from acute exacerbations, decreased the number of hospitalizations, improved dyspnea, and reduced adverse events compared to placebo. In the past decade, several studies have examined the safety and efficacy of tiotropium in comparison to placebo and to LABAs (salmeterol, formoterol, and indacaterol) over periods ranging from 3 months to 48 months of follow-up. Head-to-head comparisons of tiotropium 18 μg (once daily) with salmeterol 50 μg (twice daily) in well-controlled trials demonstrated that tiotropium was superior in reducing acute exacerbation events and in improving quality of life. In a few short-term studies, indacaterol was comparable to tiotropium in its efficacy in improving health-related outcomes. Although the safety record of tiotropium has been exemplary in comparison to placebo, anticholinergic events such as dry mouth can be encountered in some patients. While the long-term safety of tiotropium when delivered in the HandiHaler® has been well documented, its delivery using the Respimat® Soft Mist Inhaler™ was associated with an elevated risk of cardiovascular complications, including increased mortality when compared to placebo. The exact mechanism for this is not known but is being investigated in a large multinational study that will evaluate the long-term safety of different doses of tiotropium delivered by the Respimat® soft mist inhaler versus the HandiHaler®. Further studies are required to investigate the efficacy and safety of tiotropium in comparison with novel LABAs such as indacaterol and vilanterol, and with other emerging novel anticholinergic agents such as aclidinium bromide and NVA237 (glycopyrronium bromide).

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“…Furthermore, to standardize the reporting of primary CV events (MI, stroke, or heart failure) between centers (which may adopt different interpretations and event definitions), only events confirmed by the blinded adjudication committee are included. The expected event rates for MI, stroke, and heart failure are 98, 108, and 168,60 although as the study is event-driven, recruitment rates will be adjusted once the actual event rate in this population is known.…”

Section: Introductionmentioning

confidence: 99%

Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

Kardos¹,

Worsley²,

Singh³

et al. 2016

COPD

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Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

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A new user cohort study comparing the safety of long-acting inhaled bronchodilators in COPD

Cited by 29 publications

References 36 publications

Van-e cardiovascularis mellékhatásuk az inhalációs antikolinerg szereknek?

Van-e cardiovascularis mellékhatásuk az inhalációs antikolinerg szereknek?

Ten years of tiotropium: clinical impact and patient perspectives

Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

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