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Review

The safety of dual bronchodilation on cardiovascular serious adverse events in COPD

ORCID Icon, , , ORCID Icon & ORCID Icon
Pages 589-596 | Received 12 Feb 2018, Accepted 30 Apr 2018, Published online: 14 May 2018

References

  • Cazzola M, Calzetta L, Page CP, et al. Pharmacological characterization of the interaction between aclidinium bromide and formoterol fumarate on human isolated bronchi. Eur J Pharmacol. 2014;745:135–143.
  • Cazzola M, Calzetta L, Puxeddu E, et al. Pharmacological characterisation of the interaction between glycopyrronium bromide and indacaterol fumarate in human isolated bronchi, small airways and bronchial epithelial cells. Respir Res. 2016;17:70.
  • Cazzola M, Calzetta L, Segreti A, et al. Translational study searching for synergy between glycopyrronium and indacaterol. COPD. 2015;12:175–181.
  • Calzetta L, Rogliani P, Mattei M, et al. Pharmacological characterization of the interaction between tiotropium and olodaterol administered at 5:5 concentration-ratio in equine bronchi. COPD. 2017. DOI:10.1080/15412555.2017.1344627.
  • Rogliani P, Calzetta L, Ora J, et al. Clinical synergism of LABA/LAMA combinations in COPD patients. Available at http://erj.ersjournals.com/content/50/suppl_61/PA1814. Eur Resp J 2017, 50:PA1814. DOI: 10.1183/1393003.congress-2017.PA1814.
  • Cazzola M, Calzetta L, Ora J, et al. Searching for the synergistic effect between aclidinium and formoterol: from bench to bedside. Respir Med. 2015;109:1305–1311.
  • Donohue JF, Singh D, Munzu C, et al. Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: results from two randomised controlled trials. Respir Med. 2016;112:65–74.
  • Calzetta L, Rogliani P, Facciolo F, et al. Pharmacological characterization of the interaction between umeclidinium and vilanterol in human bronchi. Eur J Pharmacol. 2017;812:147-154.
  • Calzetta L, Matera MG, Cazzola M. Pharmacological interaction between LABAs and LAMAs in the airways: optimizing synergy. Eur J Pharmacol. 2015;761:168–173.
  • Cazzola M, Rogliani P, Matera MG. Escalation and de-escalation of therapy in COPD: myths, realities and perspectives. Drugs. 2015;75:1575–1585.
  • Matera MG, Rogliani P, Calzetta L, et al. Safety considerations with dual bronchodilator therapy in COPD: an update. Drug Saf. 2016;39:501–508.
  • Decramer ML, Hanania NA, Lotvall JO, et al. The safety of long-acting beta2-agonists in the treatment of stable chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2013;8:53–64.
  • Welte T, Nitschmann S. [Cardiovascular outcome in patients with COPD: study to understand mortality and morbidity (SUMMIT)]. Der Internist. 2016;57:1139–1141.
  • Vestbo J, Anderson J, Brook RD, et al. The study to understand mortality and morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013;41:1017–1022.
  • Salpeter SR, Ormiston TM, Salpeter EE. Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis. Chest. 2004;125:2309–2321.
  • Bremner P, Woodman K, Burgess C, et al. A comparison of the cardiovascular and metabolic effects of formoterol, salbutamol and fenoterol. Eur Respir J. 1993;6:204–210.
  • Tashkin DP, Littner M, Andrews CP, et al. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008;102:479–487.
  • Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Jama. 2008;300:1439–1450. .
  • Rogliani P, Calzetta L, Coppola A, et al. Optimizing drug delivery in COPD: the role of inhaler devices. Respir Med. 2017;124:6–14.
  • Cazzola M, Calzetta L, Matera MG. The cardiovascular risk of tiotropium: is it real? Expert Opin Drug Saf. 2010;9:783–792.
  • Calzetta L, Rogliani P, Matera MG, et al. A systematic review with meta-analysis of dual bronchodilation with LAMA/LABA for the treatment of stable COPD. Chest. 2016;149:1181–1196.
  • Singh D, Jones PW, Bateman ED, et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014;14:178.
  • D’Urzo A, Rennard S, Kerwin E, et al. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017;125:39–48.
  • D’Urzo AD, Rennard SI, Kerwin EM, et al. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014;15:123.
  • Donohue JF, Soong W, Wu X, et al. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: results of a randomized 1-year trial in patients with COPD. Respir Med. 2016;116:41–48.
  • Medic G, Lindner L, Van Der Weijden M, et al. Efficacy and safety of aclidinium/formoterol versus tiotropium in COPD: results of an indirect treatment comparison. Adv Ther. 2016;33:379–399.
  • Vogelmeier C, Paggiaro PL, Dorca J, et al. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016;48:1030–1039.
  • Martinez FJ, Rabe KF, Ferguson GT, et al. Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest. 2017;151:340–357.
  • Hanania NA, Tashkin DP, Kerwin EM, et al. Long-term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel co-suspension delivery technology in patients with chronic obstructive pulmonary disease. Respir Med. 2017;126:105–115.
  • Van de Maele B, Fabbri LM, Martin C, et al. Cardiovascular safety of QVA149, a combination of indacaterol and NVA237, in COPD patients. COPD. 2010;7:418–427.
  • Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42:1484–1494.
  • Vincken W, Aumann J, Chen H, et al. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. Int J Chron Obstruct Pulmon Dis. 2014;9:215–228.
  • Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1:199–209.
  • Mahler DA, Decramer M, D’Urzo A, et al. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014;43:1599–1609.
  • Beeh KM, Korn S, Beier J, et al. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014;108:584–592.
  • Vogelmeier CF, Bateman ED, Pallante J, et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013;1:51–60.
  • Wedzicha JA, Dahl R, Buhl R, et al. Pooled safety analysis of the fixed-dose combination of indacaterol and glycopyrronium (QVA149), its monocomponents, and tiotropium versus placebo in COPD patients. Respir Med. 2014;108:1498–1507.
  • Dahl R, Jadayel D, Alagappan VK, et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J Chron Obstruct Pulmon Dis. 2013;8:501–508.
  • Zhong N, Wang C, Zhou X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015–1026.
  • Vogelmeier C, Zhong N, Humphries MJ, et al. Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis. Int J Chron Obstruct Pulmon Dis. 2016;11:3189–3197.
  • Vogelmeier CF, Gaga M, Aalamian-Mattheis M, et al. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017;18:140.
  • Buhl R, Magder S, Bothner U, et al. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017;122:58–66.
  • Singh D, Gaga M, Schmidt O, et al. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res. 2016;17:73.
  • Ferguson GT, Karpel JP, Clerisme-Beaty E, et al. Efficacy and safety of tiotropium + olodaterol maintenance treatment in patients with COPD in the TONADO(R) and OTEMTO(R) studies: a subgroup analysis by age. Int J Chron Obstruct Pulmon Dis. 2016;11:2701–2710.
  • Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015;45:969–979.
  • Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015;109:1312–1319.
  • Aalbers R, Maleki-Yazdi MR, Hamilton A, et al. Randomized, double-blind, dose-finding study for tiotropium when added to olodaterol, administered via the respimat(r) inhaler in patients with chronic obstructive pulmonary disease. Adv Ther. 2015;32:809–822.
  • Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25mcg in COPD. Respir Med. 2013;107:1538–1546.
  • Celli B, Crater G, Kilbride S, et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014;145:981–991.
  • Kalberg C, O’Dell D, Galkin D, et al. Dual bronchodilator therapy with umeclidinium/vilanterol versus tiotropium plus indacaterol in chronic obstructive pulmonary disease: a randomized controlled trial. Drugs in R&D. 2016;16:217–227.
  • Singh D, Worsley S, Zhu CQ, et al. Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. BMC Pulm Med. 2015;15:91.
  • Feldman G, Walker RR, Brooks J, et al. 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther. 2012;25:465–471.
  • Celli B, Crater G, Kilbride S, et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014;145:981–991.
  • Kerwin E, Ferguson GT, Sanjar S, et al. Dual bronchodilation with indacaterol maleate/glycopyrronium bromide compared with umeclidinium bromide/vilanterol in patients with moderate-to-severe COPD: results from two randomized, controlled, cross-over studies. Lung. 2017;195:739–747.
  • Rogliani P, Matera MG, Ora J, et al. The impact of dual bronchodilation on cardiovascular serious adverse events and mortality in COPD: a quantitative synthesis. Int J COPD. 2017;12:3469–3485.
  • Rodrigo GJ, Price D, Anzueto A, et al. LABA/LAMA combinations versus LAMA monotherapy or LABA/ICS in COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2017;12:907–922.
  • Feldman GJ, Sousa AR, Lipson DA, et al. Comparative efficacy of once-daily umeclidinium/vilanterol and tiotropium/olodaterol therapy in symptomatic chronic obstructive pulmonary disease: a randomized study. Adv Ther. 2017;34:2518-2533.
  • Chou TC. Theoretical basis, experimental design, and computerized simulation of synergism and antagonism in drug combination studies. Pharmacol Rev. 2006;58:621–681.
  • Calzetta L, Ora J, Cavalli F, et al. Impact of LABA/LAMA combination on exercise endurance and lung hyperinflation in COPD: a pair-wise and network meta-analysis. Respir Med. 2017;129:189–198.
  • Calzetta L, Rogliani P, Ora J, et al. LABA/LAMA combination in COPD: a meta-analysis on the duration of treatment. Eur Respir Rev. 2017;26:1–11.
  • Tashkin DP. The safety of anticholinergic bronchodilators for the treatment of chronic obstructive pulmonary disease. Expert Opin Drug Saf. 2015;14:1759–1772.
  • Wang MT, Liou JT, Lin CW, et al. Association of cardiovascular risk with inhaled long-acting bronchodilators in patients with chronic obstructive pulmonary disease: a nested case-control study. JAMA Intern Med. 2018;178:229-238.
  • Suissa S, Dell’Aniello S, Ernst P. Long-acting bronchodilator initiation in COPD and the risk of adverse cardiopulmonary events: a population-based comparative safety study. Chest. 2017;151:60–67.
  • Suissa S, Dell’Aniello S, Ernst P. Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events. Eur Respir J. 2017;49:1602245.

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