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N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

A 4-year trial of tiotropium in chronic obstructive pulmonary disease.

Collaborators (501)

Schiavi E, Figueroa Casas JC, Rhodius E, Gené R, Benito Sáenz C, Giugno E, Di Bartolo C, De Salvo MC, Abbate E, López AM, Steinfort C, Peters M, Carroll P, Simpson G, Freiberg D, Fogarty P, Watts R, Wheatley J, Vetter N, Burghuber O, Hesse C, Flicker M, Kähler C, Bral G, Carron K, Coolen D, De Backer W, De Beukelaar T, Decramer M, Deman R, Dewispelaere B, Driesen P, Elinck W, Mentens Y, Vandeurzen K, Van Renterghem D, Van Zandweghe L, Verhaeghe W, Vincken W, Delaunois L, Duchatelet P, Noseda A, Nuttin G, Rodenstein D, Thibaut-Baudrez A, Vandermoten G, Wackenier-Genard P, Baldassarre S, Schlesser M, Barreto SS, Corrêa JC, da Silva LC, Fiss E, Chibante AM, de Mattos WL, Fritscher CC, de Oliveira JA, Pizzichini E, Neves M, Cruz A, Pereira CA, Cukier A, Stirbulov R, Jardim JR, Kalandrova K, Novakova M, Hartman P, Jensovsky V, Vacek J, Kasak V, Erban J, Kalina P, Chlumsky J, Musil J, Hojka I, Havlikova A, Mares J, Klenha K, Vondra V, Havlik M, Parakova Z, Vlcek J, Dvorakova J, Mazacova H, Velart D, Pospisil L, Zajicova O, Kolman P, Binková I, Fratrik J, Lange P, Backer V, Dahl R, Harving H, Tønnesen P, Munch E, Rasmussen OB, Tougaard L, Egede F, Hansen NC, Høegholm A, Rasmussen FV, Jakobsen KS, Wessels J, Frandsen JL, Evald T, Hilskov J, Garsdal P, Nielsen C, Haahr S, Korsgaard J, Revsbeck PA, Hansen JG, Soerensen T, Arnved JR, Møller A, Enevoldsen H, Døssing M, Christensen P, Christensen KD, Frølund L, Venho K, Pietiläinen M, Saarelainen P, Kotaniemi J, Männistö J, Aubier M, Pigearias B, Malaquin F, Grunchec N, Bernabeu L, Carme B, Prud'homme A, Bonte F, Boz D, Meunier R, Rasolojaona MT, Apprill M, Fargeon R, Bernard P, Tirouvanziam F, Legendre M, Jasnot JY, Barczok M, Becker JC, Pilz M, Grimm-Sachs V, Jahn M, Kemmerich B, Vorderstrasse W, Klein G, Kroemer B, Lehnert J, Redlich R, Schmidtmann S, Schultz T, Weber HH, Siafakas N, Anagnostopoulou O, Toubis M, Gourgoulianis K, Sichletides L, Kakoura M, Christaki P, Lychros I, Spiropoulos K, Bousmoukilia S, Hui DS, Yu WC, Chan HS, Wong ML, Baliko Z, Bisits M, Böszörményi G, Marton M, Fonay K, Györi Z, Hajdu L, Lukács J, Kovacs G, Magyar P, Nagy G, Namenyi M, Meszaros E, Petö L, Somfay A, Kiraly Z, Strausz J, Szalai Z, Szilasi M, Szima B, Sztancsik Z, Costello R, Burke C, Paggiaro PL, Mazzocchi P, Cattaneo C, Peccini F, Dottorini M, Dottorini M, Tazza R, Pirina P, Ginesu F, Ortu R, Sugamiele M, Mastroberardino M, Anzalone G, Canonica GW, De Benedetto F, Falcone F, Greco P, Papi A, Ciaccia A, Vincenti R, Parentini G, Tubaldi A, De Rose V, Ferretti G, Gasparini S, Legnani D, Ligia GP, Padua V, Santelli G, Mazza F, Boccieri MG, Cogo R, Pegna AL, Pistolesi M, Colorizio V, Zanon P, Nishimura M, Yamauchi K, Ogawa H, Hattori T, Ichinose M, Kimura K, Kaneko N, Seyama K, Fukuchi Y, Kubo K, Taniguchi H, Hirata K, Tohda Y, Aizawa H, Matsumoto S, Sakalauskas R, Bagdonas A, Nargela RV, Mahayiddin AA, Harun R, Liam CK, Ortiz Peregrina JR, Díaz Castañón JJ, Posadas Valay R, Sansores Martínez RH, Domínguez Peregrina A, van Noord J, Aalbers R, Creemers JP, Dalinghaus WH, Eland ME, Pannekoek BJ, Pasma HR, Rudolphus A, Damsté HE, Evers WB, Gans SJ, Timmer H, Westbroek J, Black P, Epton M, Dahle R, Eivindson A, Asmervik J, Lier PA, Cañizares-Fernandez L, Guzman-Banzon A, Aquino T, Sy-Naval S, Trinidad T, Gorecka D, Plusa TP, Pisarczyk-Bogacka E, Gorski P, Kozielski J, Pierzchala W, Szczeklik A, Kuna P, Slominksi JM, Almeida J, Sá R, Bárbara C, Pato R, Moita J, Cardoso J, Chuchalin AG, Ovtcharenko S, Nonikov V, Ilkovich M, Tsoi A, Wang YT, Lo C, Lim TK, Kristufek P, Chovan L, Rozborilova E, Salat D, Plutinsky J, Suskovic S, Kosnik M, Turel M, Rezar L, Ulcar-Kostic S, Ras GJ, Du Toit JJ, Herbst L, van der Linden M, Nel AM, Jansen JJ, Bester FC, Colyn HJ, Abdullah I, Abdullah IA, Bateman E, Heredia Budó JL, Marín Pardo J, Miravitlles M, Izquierdo Alonso JL, Val Adán P, Morera J, Ferrer J, Alvarez-Sala JL, Fernández Francés J, Fuentes Otero F, Ferreiro Alvarez MJ, Verea Hernando H, Marín Pérez A, Hernández Flix S, Sueiro Bendito A, Bandrés Gimeno R, Montemayor T, Fernández-Montes CV, Navas Vazquez S, Sobradillo Peña V, Rubio Goday M, Baloira Villar A, Blanquer Olivas R, Romero Candeira S, Agustí A, Ancochea J, Marín Trigo JM, Rodríguez González-Moro JM, Brotons B, Merino J, Perpiñá Tordera M, Ortega Ruiz F, López Encuentra A, Batista JJ, Suárez Pinilla FJ, Agüero R, Russi E, Solèr M, Tamm M, Bräendli O, Pons M, Tschopp JM, Hess T, Kuo HP, Shiao GM, Pothirat C, Wongtim S, Kiatboonsri S, Dejsomritrutai W, Boonsawat W, Erk M, Tuncay E, Celikel T, Caglayan B, Tabak L, Cöplü L, Ardiç S, Ucar N, Mirici A, Kocabas A, Erginel S, Cimrin AH, Mansur A, Bucknall C, Griffiths P, Halpin D, Morgan M, Morice A, Anderson P, Plant P, Britton M, Harrison T, Crooks S, Shales D, Douglas G, Gravil J, Altose MD, Amgott T, Andrews CP, Cote C, Averill F, Bailey W, Bensch G, Bleecker ER, Koh D, Block M, Braman S, Brannen AL, Brazinsky SA, Bruya T, Callahan D, Celli B, Condemi JJ, Corser B, Osmanski J, Craig T, Degraff A, Doherty DE, Anderson M, Doner M, Donohue J, Eichenhorn M, Ettinger N, Govert J, Folz R, Lasky J, Kovitz K, Friedman M, Giessel G, Pomerantz R, Castillo G, Greenwald GI, Hanania N, Hautamaki RD, Henderson W 4th, Heyder A, Hyers T, Ilowite J, Janes M, Kahn R, Harder R, Kaiser H, Kanner RE, Kaye M, Kreitzer S, Lawlor D, Leech I, Levine B, Littner M, Jarmukli N, Liu J, Lorch DG, Mahler D, Make B, Mandel M, Mathur P, Meyer DH, Milam MG, Mohsenifar Z, Moriarty T, Otoshi J, Patel R, Pratt A, Prenner B, Rehm J, Repsher L, Ries A, Rock KB, Sharafkhaneh A, San Pedro G, Scanlon PD, Scheinberg P, Schelbar EJ, Schul J, Fine J, Segall N, Seibert A, Serfillipi GL, Spirn I, Sussman R, Tashkin D, Wachtel A, Westerman J, Wise RA, Zielinski R, ZuWallack R, Ferguson G, Gelb A, Kuschner W, Mahutte K, Martinez F, Plautz M, Rochester C, Schilero G, Tino G, Turino G, Keppel J.

Author information

  • 1David Geffen School of Medicine at the University of California, Los Angeles 90095-1690,USA. dtashkin@mednet.ucla.edu

Abstract

BACKGROUND:

Previous studies showing that tiotropium improves multiple end points in patients with chronic obstructive pulmonary disease (COPD) led us to examine the long-term effects of tiotropium therapy.

METHODS:

In this randomized, double-blind trial, we compared 4 years of therapy with either tiotropium or placebo in patients with COPD who were permitted to use all respiratory medications except inhaled anticholinergic drugs. The patients were at least 40 years of age, with a forced expiratory volume in 1 second (FEV(1)) of 70% or less after bronchodilation and a ratio of FEV(1) to forced vital capacity (FVC) of 70% or less. Coprimary end points were the rate of decline in the mean FEV(1) before and after bronchodilation beginning on day 30. Secondary end points included measures of FVC, changes in response on St. George's Respiratory Questionnaire (SGRQ), exacerbations of COPD, and mortality.

RESULTS:

Of a total of 5993 patients (mean age, 65+/-8 years) with a mean FEV(1) of 1.32+/-0.44 liters after bronchodilation (48% of predicted value), we randomly assigned 2987 to the tiotropium group and 3006 to the placebo group. Mean absolute improvements in FEV(1) in the tiotropium group were maintained throughout the trial (ranging from 87 to 103 ml before bronchodilation and from 47 to 65 ml after bronchodilation), as compared with the placebo group (P<0.001). After day 30, the differences between the two groups in the rate of decline in the mean FEV(1) before and after bronchodilation were not significant. The mean absolute total score on the SGRQ was improved (lower) in the tiotropium group, as compared with the placebo group, at each time point throughout the 4-year period (ranging from 2.3 to 3.3 units, P<0.001). At 4 years and 30 days, tiotropium was associated with a reduction in the risks of exacerbations, related hospitalizations, and respiratory failure.

CONCLUSIONS:

In patients with COPD, therapy with tiotropium was associated with improvements in lung function, quality of life, and exacerbations during a 4-year period but did not significantly reduce the rate of decline in FEV(1). (ClinicalTrials.gov number, NCT00144339.)

2008 Massachusetts Medical Society

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PMID:
18836213
[PubMed - indexed for MEDLINE]
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