Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNIFESP |
Texto Completo: | http://repositorio.unifesp.br/handle/11600/36570 http://dx.doi.org/10.1378/chest.12-2613 |
Resumo: | Background: Disease progression in COPD is associated with a decline in exercise performance over time. We assessed whether tiotropium might mitigate this by determining its effect on treadmill endurance time (ET) over 2 years.Methods: This was a randomized, double-blind, placebo-controlled trial of tiotropium, 18 mu g daily, in patients with COPD (FEV1/FVC <70%; postbronchodilator FEV1 <65%). the primary end point was ET at 90% of baseline maximum work rate at 96 weeks. Secondary end points were ET at other visits, ET by smoking status, spirometry, and St. George's Respiratory Questionnaire (SGRQ).Results: A total of 519 patients were randomized (tiotropium 260, placebo 259). Mean age was 65 years, 77% were men, 34% were continuing smokers, and mean FEV1 was 1.25 L (44% predicted). Significantly more patients discontinued placebo (hazard ratio [95% CI], 0.61 [0.44-0.83]). Baseline ET was 301 s (improvement tiotropium/placebo was 13% overall; P = .009; 18% at 48 weeks, P = .004; 13% at 96 weeks, P = .106). in patients with baseline ET between 2 and 10 min (n = 404), improvement at 96 weeks was 19% (P = .04). Current smokers had higher ET with tiotropium vs placebo (P = .018). FEV1/FVC improved with tiotropium (P < .01). SGRQ total score at 96 weeks improved with tiotropium vs placebo by 4.03 units (P = .007).Conclusions: Treadmill ET was numerically greater over 2 years with tiotropium vs placebo. However, the 96-week difference was not statistically significant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefits of long-acting bronchodilator therapy.Trial registry: ClinicalTrials.gov; No.: NCT00525512; URL: www.clinicaltrials.gov |
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Cooper, Christopher B.Celli, Bartolome R.Jardim, Jose R. [UNIFESP]Wise, Robert A.Legg, DanielGuo, JunhaiKesten, StevenUniv Calif Los AngelesBrigham & Womens HospUniversidade Federal de São Paulo (UNIFESP)Johns Hopkins Asthma & Allergy CtrBoehringer Ingelheim Pharmaceut IncCytori Therapeut Inc2016-01-24T14:32:02Z2016-01-24T14:32:02Z2013-08-01Chest. Northbrook: Amer Coll Chest Physicians, v. 144, n. 2, p. 490-497, 2013.0012-3692http://repositorio.unifesp.br/handle/11600/36570http://dx.doi.org/10.1378/chest.12-261310.1378/chest.12-2613WOS:000323021400023Background: Disease progression in COPD is associated with a decline in exercise performance over time. We assessed whether tiotropium might mitigate this by determining its effect on treadmill endurance time (ET) over 2 years.Methods: This was a randomized, double-blind, placebo-controlled trial of tiotropium, 18 mu g daily, in patients with COPD (FEV1/FVC <70%; postbronchodilator FEV1 <65%). the primary end point was ET at 90% of baseline maximum work rate at 96 weeks. Secondary end points were ET at other visits, ET by smoking status, spirometry, and St. George's Respiratory Questionnaire (SGRQ).Results: A total of 519 patients were randomized (tiotropium 260, placebo 259). Mean age was 65 years, 77% were men, 34% were continuing smokers, and mean FEV1 was 1.25 L (44% predicted). Significantly more patients discontinued placebo (hazard ratio [95% CI], 0.61 [0.44-0.83]). Baseline ET was 301 s (improvement tiotropium/placebo was 13% overall; P = .009; 18% at 48 weeks, P = .004; 13% at 96 weeks, P = .106). in patients with baseline ET between 2 and 10 min (n = 404), improvement at 96 weeks was 19% (P = .04). Current smokers had higher ET with tiotropium vs placebo (P = .018). FEV1/FVC improved with tiotropium (P < .01). SGRQ total score at 96 weeks improved with tiotropium vs placebo by 4.03 units (P = .007).Conclusions: Treadmill ET was numerically greater over 2 years with tiotropium vs placebo. However, the 96-week difference was not statistically significant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefits of long-acting bronchodilator therapy.Trial registry: ClinicalTrials.gov; No.: NCT00525512; URL: www.clinicaltrials.govBoehringer Ingelheim Pharma GmbH Co KGPfizer, Inc.Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USABrigham & Womens Hosp, Boston, MA 02115 USAUniversidade Federal de São Paulo, São Paulo, BrazilJohns Hopkins Asthma & Allergy Ctr, Baltimore, MD USABoehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USACytori Therapeut Inc, San Diego, CA USAUniversidade Federal de São Paulo, EPM, São Paulo, BrazilWeb of Science490-497engAmer Coll Chest PhysiciansChestTreadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP11600/365702022-09-27 09:48:39.219metadata only accessoai:repositorio.unifesp.br:11600/36570Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652022-09-27T12:48:39Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
dc.title.en.fl_str_mv |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
title |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
spellingShingle |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial Cooper, Christopher B. |
title_short |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
title_full |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
title_fullStr |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
title_full_unstemmed |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
title_sort |
Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial |
author |
Cooper, Christopher B. |
author_facet |
Cooper, Christopher B. Celli, Bartolome R. Jardim, Jose R. [UNIFESP] Wise, Robert A. Legg, Daniel Guo, Junhai Kesten, Steven |
author_role |
author |
author2 |
Celli, Bartolome R. Jardim, Jose R. [UNIFESP] Wise, Robert A. Legg, Daniel Guo, Junhai Kesten, Steven |
author2_role |
author author author author author author |
dc.contributor.institution.none.fl_str_mv |
Univ Calif Los Angeles Brigham & Womens Hosp Universidade Federal de São Paulo (UNIFESP) Johns Hopkins Asthma & Allergy Ctr Boehringer Ingelheim Pharmaceut Inc Cytori Therapeut Inc |
dc.contributor.author.fl_str_mv |
Cooper, Christopher B. Celli, Bartolome R. Jardim, Jose R. [UNIFESP] Wise, Robert A. Legg, Daniel Guo, Junhai Kesten, Steven |
description |
Background: Disease progression in COPD is associated with a decline in exercise performance over time. We assessed whether tiotropium might mitigate this by determining its effect on treadmill endurance time (ET) over 2 years.Methods: This was a randomized, double-blind, placebo-controlled trial of tiotropium, 18 mu g daily, in patients with COPD (FEV1/FVC <70%; postbronchodilator FEV1 <65%). the primary end point was ET at 90% of baseline maximum work rate at 96 weeks. Secondary end points were ET at other visits, ET by smoking status, spirometry, and St. George's Respiratory Questionnaire (SGRQ).Results: A total of 519 patients were randomized (tiotropium 260, placebo 259). Mean age was 65 years, 77% were men, 34% were continuing smokers, and mean FEV1 was 1.25 L (44% predicted). Significantly more patients discontinued placebo (hazard ratio [95% CI], 0.61 [0.44-0.83]). Baseline ET was 301 s (improvement tiotropium/placebo was 13% overall; P = .009; 18% at 48 weeks, P = .004; 13% at 96 weeks, P = .106). in patients with baseline ET between 2 and 10 min (n = 404), improvement at 96 weeks was 19% (P = .04). Current smokers had higher ET with tiotropium vs placebo (P = .018). FEV1/FVC improved with tiotropium (P < .01). SGRQ total score at 96 weeks improved with tiotropium vs placebo by 4.03 units (P = .007).Conclusions: Treadmill ET was numerically greater over 2 years with tiotropium vs placebo. However, the 96-week difference was not statistically significant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefits of long-acting bronchodilator therapy.Trial registry: ClinicalTrials.gov; No.: NCT00525512; URL: www.clinicaltrials.gov |
publishDate |
2013 |
dc.date.issued.fl_str_mv |
2013-08-01 |
dc.date.accessioned.fl_str_mv |
2016-01-24T14:32:02Z |
dc.date.available.fl_str_mv |
2016-01-24T14:32:02Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
Chest. Northbrook: Amer Coll Chest Physicians, v. 144, n. 2, p. 490-497, 2013. |
dc.identifier.uri.fl_str_mv |
http://repositorio.unifesp.br/handle/11600/36570 http://dx.doi.org/10.1378/chest.12-2613 |
dc.identifier.issn.none.fl_str_mv |
0012-3692 |
dc.identifier.doi.none.fl_str_mv |
10.1378/chest.12-2613 |
dc.identifier.wos.none.fl_str_mv |
WOS:000323021400023 |
identifier_str_mv |
Chest. Northbrook: Amer Coll Chest Physicians, v. 144, n. 2, p. 490-497, 2013. 0012-3692 10.1378/chest.12-2613 WOS:000323021400023 |
url |
http://repositorio.unifesp.br/handle/11600/36570 http://dx.doi.org/10.1378/chest.12-2613 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.none.fl_str_mv |
Chest |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
490-497 |
dc.publisher.none.fl_str_mv |
Amer Coll Chest Physicians |
publisher.none.fl_str_mv |
Amer Coll Chest Physicians |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
instname_str |
Universidade Federal de São Paulo (UNIFESP) |
instacron_str |
UNIFESP |
institution |
UNIFESP |
reponame_str |
Repositório Institucional da UNIFESP |
collection |
Repositório Institucional da UNIFESP |
repository.name.fl_str_mv |
Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
repository.mail.fl_str_mv |
|
_version_ |
1802764165019860992 |