Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD

Vogelmeier, Claus and Hederer, Bettina and Glaab, Thomas and Schmidt, Hendrik and Rutten-van Mölken, Maureen P.M.H. and Beeh, Kai M. and Rabe, Klaus F. and Fabbri, Leonardo M. and for the POET-COPD Investigators and Ukraine and Dzyublyk, Oleksandr and Gavrysiuk, Volodymyr and Kostromina, Victoria and Palamar, Boris and Grishyna, Olena and Korzh, Oleksiy Mykilayovych and Amer, Ludmila Georgyivna and Pertseva, Tetyana and Rodionova, Vicktoriya and Kuriata, Oleksandr and Vdovychenko, Valeriy and Telyatnikova, Zinaida Efimovna and Monogarova, Nadiya and Vizir, Vadym and Chernyak, Valeriy and Koshukova, Galyna and Gospodarskyy, Igor and Popik, Galyna and Rudyk, Yuriy and Biloglazov, Volodymyr and Blazhko, Viktor and Panina, Svitlana and Ignatenko, Grigoriy and Girina, Olga and Kashtelyan, Oleg and Voloshyna, Olena and Svintsitskyy, Anatoliy and Mostovoiy, Yuriy and Abrahamovych, Orest Ostapovych and Skrypnyk, Igor and Pasiyeshvily, Ludmila Mykhaylivna and Ostrovskiy, Myckola and Netiazhenko, Vasyl and Dudar, Larysa and Romaniuk, Lilia and Sakharchuk, Ivan and Semidotska, Zhanna and Bazylevych, Andrey and Vlasenko, Mykhaylo and Smolyanyy, Olexander and Khodosh, Eduard and Putintsev, Volodymir and Syvolap, Vitalyy Viktorovich and Fushtey, Ivan Mykhaylovych and Plesh, Igor Antonovich and Diachenko, Anatoliy and Tsokalo, Viktoriya and Feshchenko, Yuriy and Iashyna, Liudmyla and Chopyak, Valentyna and Yabluchanskyy, Mykola and Nalyotov, Sergiy (2011) Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD. The New England Journal of Medicine = N Engl J Med, 364 (12). pp. 1093-1103. ISSN 0028-4793 (print); 1533-4406 (online)

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Abstract

BACKGROUND Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-tovery-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β2-agonist salmeterol in preventing exacerbations of COPD. METHODS In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year. RESULTS A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P=0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group. CONCLUSIONS These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.)

Item Type:	Article
Additional Information:	https://www.nejm.org/doi/full/10.1056/nejmoa1008378
Subjects:	Internal Medicine Pulmonology
Divisions:	Departments > Department of Internal Medicine 1 (formerly - Faculty Therapy and Endocrinology) Departments > Department of Internal Medicine 3 (formerly - hospital therapy 2)
Depositing User:	Елена Шрамко
Date Deposited:	10 Oct 2022 11:15
Last Modified:	10 Oct 2022 11:16
URI:	http://repo.dma.dp.ua/id/eprint/7857

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