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A 4-year trial of tiotropium in chronic obstructive pulmonary disease.
N Engl J Med. 2008 Oct 09; 359(15):1543-54.NEJM

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.)

Authors+Show Affiliations

David Geffen School of Medicine at the University of California, Los Angeles 90095-1690,USA. dtashkin@mednet.ucla.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18836213

Citation

Tashkin, Donald P., et al. "A 4-year Trial of Tiotropium in Chronic Obstructive Pulmonary Disease." The New England Journal of Medicine, vol. 359, no. 15, 2008, pp. 1543-54.
Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543-54.
Tashkin, D. P., Celli, B., Senn, S., Burkhart, D., Kesten, S., Menjoge, S., & Decramer, M. (2008). A 4-year trial of tiotropium in chronic obstructive pulmonary disease. The New England Journal of Medicine, 359(15), 1543-54. https://doi.org/10.1056/NEJMoa0805800
Tashkin DP, et al. A 4-year Trial of Tiotropium in Chronic Obstructive Pulmonary Disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. PubMed PMID: 18836213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 4-year trial of tiotropium in chronic obstructive pulmonary disease. AU - Tashkin,Donald P, AU - Celli,Bartolome, AU - Senn,Stephen, AU - Burkhart,Deborah, AU - Kesten,Steven, AU - Menjoge,Shailendra, AU - Decramer,Marc, AU - ,, Y1 - 2008/10/05/ PY - 2008/10/7/pubmed PY - 2008/10/29/medline PY - 2008/10/7/entrez SP - 1543 EP - 54 JF - The New England journal of medicine JO - N Engl J Med VL - 359 IS - 15 N2 - 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/18836213/A_4_year_trial_of_tiotropium_in_chronic_obstructive_pulmonary_disease_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa0805800?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -