Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD

References

• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease (2019 report). Published 2019 Available from: https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf. Accessed 117, 2019.
   Google Scholar
• TashkinDP, CelliB, SennS, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543–1554. doi:10.1056/NEJMoa080580018836213
   PubMed Web of Science ®Google Scholar
• KochA, PizzichiniE, HamiltonA, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:697–714. doi:10.2147/COPD.S6250225045258
   PubMed Web of Science ®Google Scholar
• BuhlR, MaltaisF, AbrahamsR, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015;45(4):969–979. doi:10.1183/09031936.0013601425573406
   PubMed Web of Science ®Google Scholar
• FearyJR, RodriguesLC, SmithCJ, HubbardRB, GibsonJE. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010;65(11):956–962. doi:10.1136/thx.2009.12808220871122
   PubMed Web of Science ®Google Scholar
• FuhrmanC, JouglaE, NicolauJ, EilsteinD, DelmasMC. Deaths from chronic obstructive pulmonary disease in France, 1979–2002: a multiple cause analysis. Thorax. 2006;61(11):930–934. doi:10.1136/thx.2006.06126716738039
   PubMed Web of Science ®Google Scholar
• HuiartL, ErnstP, SuissaS. Cardiovascular morbidity and mortality in COPD. Chest. 2005;128(4):2640–2646. doi:10.1378/chest.128.4.264016236937
   PubMed Web of Science ®Google Scholar
• KarchA, VogelmeierC, WelteT, et al. The German COPD cohort COSYCONET: aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016;114:27–37. doi:10.1016/j.rmed.2016.03.00827109808
   PubMed Web of Science ®Google Scholar
• AlterP, MayerhoferB, KahnertK, et al. Prevalence of cardiac comorbidities, and their underdetection and contribution to exertional symptoms in COPD: results from the COSYCONET cohort. Int J Chron Obstruct Pulmon Dis. 2019;14:2163–2172. doi:10.2147/COPD.S20934331571852
   PubMed Web of Science ®Google Scholar
• SidneyS, SorelM, QuesenberryCP, DeLuiseC, LanesS, EisnerMD. COPD and incident cardiovascular disease hospitalizations and mortality:Kaiser Permanente Medical Care Program. Chest. 2005;128(4):2068–2075. doi:10.1378/chest.128.4.206816236856
   PubMed Web of Science ®Google Scholar
• ByrdJB, NewbyDE, AndersonJA, et al. Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial. Eur Heart J. 2018;39(33):3128–3134. doi:10.1093/eurheartj/ehy45130101300
   PubMed Web of Science ®Google Scholar
• AndreasS, AnkerSD, ScanlonPD, SomersVK. Neurohumoral activation as a link to systemic manifestations of chronic lung disease. Chest. 2005;128(5):3618–3624. doi:10.1378/chest.128.5.361816304321
   PubMed Web of Science ®Google Scholar
• CohnJN, LevineTB, OlivariMT, et al. Plasma norepinephrine as a guide to prognosis in patients with chronic congestive heart failure. N Engl J Med. 1984;311(13):819–823. doi:10.1056/NEJM1984092731113036382011
   PubMed Web of Science ®Google Scholar
• JensenMT, SuadicaniP, HeinHO, GyntelbergF. Elevated resting heart rate, physical fitness and all-cause mortality: a 16-year follow-up in the Copenhagen Male Study. Heart. 2013;99(12):882–887. doi:10.1136/heartjnl-2012-30337523595657
   PubMed Web of Science ®Google Scholar
• AndreasS, HaarmannH, KlarnerS, HasenfussG, RaupachT. Increased sympathetic nerve activity in COPD is associated with morbidity and mortality. Lung. 2014;192(2):235–241. doi:10.1007/s00408-013-9544-724362752
   PubMed Web of Science ®Google Scholar
• SchrierRW, AbrahamWT. Hormones and hemodynamics in heart failure. N Engl J Med. 1999;341(8):577–585. doi:10.1056/NEJM19990819341080610451464
   PubMed Web of Science ®Google Scholar
• BangaloreS, MesserliFH, WunCC, et al. J-curve revisited: an analysis of blood pressure and cardiovascular events in the Treating to New Targets (TNT) trial. Eur Heart J. 2010;31(23):2897–2908. doi:10.1093/eurheartj/ehq32820846991
   PubMed Web of Science ®Google Scholar
• MesserliFH, PanjrathGS. The J-curve between blood pressure and coronary artery disease or essential hypertension: exactly how essential? J Am Coll Cardiol. 2009;54(20):1827–1834. doi:10.1016/j.jacc.2009.05.07319892233
   PubMed Web of Science ®Google Scholar
• LahousseL, VerhammeKM, StrickerBH, BrusselleGG. Cardiac effects of current treatments of chronic obstructive pulmonary disease. Lancet Respir Med. 2016;4(2):149–164. doi:10.1016/S2213-2600(15)00518-426794033
   PubMed Web of Science ®Google Scholar
• CazzolaM, ImperatoreF, SalzilloA, et al. Cardiac effects of formoterol and salmeterol in patients suffering from COPD with preexisting cardiac arrhythmias and hypoxemia. Chest. 1998;114(2):411–415. doi:10.1378/chest.114.2.4119726723
   PubMed Web of Science ®Google Scholar
• HohlfeldJM, Vogel-ClaussenJ, BillerH, et al. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial. Lancet Respir Med. 2018;6(5):368–378. doi:10.1016/S2213-2600(18)30054-729477448
   PubMed Web of Science ®Google Scholar
• StoneIS, BarnesNC, JamesWY, et al. Lung deflation and cardiovascular structure and function in chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2016;193(7):717–726. doi:10.1164/rccm.201508-1647OC26550687
   PubMed Web of Science ®Google Scholar
• Vogel-ClaussenJ, SchonfeldCO, KaireitTF, et al. Effect of indacaterol/glycopyrronium on pulmonary perfusion and ventilation in hyperinflated COPD patients (CLAIM): a double-blind, randomised, crossover trial. Am J Respir Crit Care Med. 2019;199(9):1086–1096. doi:10.1164/rccm.201805-0995OC30641027
   PubMed Web of Science ®Google Scholar
• AndreasS, BothnerU, TrampischM, HaenselM, BuhlR, AlterP. Effect of long-acting β2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients. Pulm Pharmacol Ther. 2018;52:1–6. doi:10.1016/j.pupt.2018.08.00230077810
   PubMed Web of Science ®Google Scholar
• HohlfeldJM, FurtwaenglerA, Konen-BergmannM, WallensteinG, WalterB, BatemanED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015;69(1):72–80. doi:10.1111/ijcp.1259625496316
   PubMed Web of Science ®Google Scholar
• AndreasS, BothnerU, de la HozA, KloerI, TrampischM, AlterP. A post hoc Holter ECG analysis of olodaterol and formoterol in moderate-to-very-severe COPD. Int J Chron Obstruct Pulmon Dis. In press 2020.
   Web of Science ®Google Scholar
• RoglianiP, MateraMG, OraJ, CazzolaM, CalzettaL. The impact of dual bronchodilation on cardiovascular serious adverse events and mortality in COPD: a quantitative synthesis. Int J Chron Obstruct Pulmon Dis. 2017;12:3469–3485. doi:10.2147/COPD.S14633829255354
   PubMed Web of Science ®Google Scholar
• QuanjerPH, TammelingGJ, CotesJE, PedersenOF, PeslinR, YernaultJC. Lung volumes and forced ventilatory flows. Eur Respir J. 1993;6(suppl 16):5–40. doi:10.1183/09041950.005s1693
   PubMed Web of Science ®Google Scholar
• PonikowskiP, VoorsAA, AnkerSD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016;37(27):2129–2200. doi:10.1093/eurheartj/ehw12827206819
   PubMed Web of Science ®Google Scholar
• GershonA, CroxfordR, CalzavaraA, et al. Cardiovascular safety of inhaled long-acting bronchodilators in individuals with chronic obstructive pulmonary disease. JAMA Intern Med. 2013;173(13):1175–1185. doi:10.1001/jamainternmed.2013.101623689820
   PubMed Web of Science ®Google Scholar
• BlairHA, DeeksED. Umeclidinium/vilanterol: a review of its use as maintenance therapy in adults with chronic obstructive pulmonary disease. Drugs. 2015;75(1):61–74. doi:10.1007/s40265-014-0326-125398674
   PubMed Web of Science ®Google Scholar
• KozielskiJ. Cardiovascular safety of two bronchodilators’ fixed-dose combination: indacaterol and glycopyrronium. Pneumonol Alergol Pol. 2015;83(2):164–170. doi:10.5603/PiAP.2015.002625754060
   PubMedGoogle Scholar
• VestboJ, LeatherD, Diar BakerlyN, et al. Effectiveness of fluticasone furoate-vilanterol for COPD in clinical practice. N Engl J Med. 2016;375(13):1253–1260. doi:10.1056/NEJMoa160803327593504
   PubMed Web of Science ®Google Scholar
• CalverleyPM, AndersonJA, CelliB, et al. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010;65(8):719–725. doi:10.1136/thx.2010.13607720685748
   PubMed Web of Science ®Google Scholar
• BuhlR, MagderS, BothnerU, 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. doi:10.1016/j.rmed.2016.11.01127993292
   PubMed Web of Science ®Google Scholar
• AndreasS, BothnerU, de la HozA, KloerI, TrampischM, AlterP. No influence on cardiac arrhythmia or heart rate from long-term treatment with tiotropium/olodaterol versus monocomponents by holter ECG analysis in patients with moderate-to-very-severe COPD. Int J Chron Obstruct Pulmon Dis. In press 2020.
   Web of Science ®Google Scholar