TY - JOUR
T1 - Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR® trial
AU - Wise, Robert A.
AU - Calverley, Peter M.A.
AU - Carter, Kerstine
AU - Clerisme-Beaty, Emmanuelle
AU - Metzdorf, Norbert
AU - Anzueto, Antonio
N1 - Funding Information:
This work was supported by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. The authors received no direct compensation related to the development of the manuscript. Writing and editorial support was provided by Jane M Gilbert BSc CMPP of Envision Scientific Solutions, which was contracted and funded by BIPI. An abstract of this article was presented as an oral presentation at Chest 2014, October 25–30, 2014, Austin, TX, USA, and the abstract was published in Chest. 2014;146(4, Suppl 2):66A.
Funding Information:
RAW reports personal fees and grants from Boehringer Ingelheim during the conduct of the study. He reports personal fees from AstraZeneca, Boehringer Ingelheim, ContraFect, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Pulmonx, Roche, Spiration, Sunovion, Teva, Theravance, Verona, and Vertex; and grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Pearl Therapeutics outside the submitted work. PMAC reports grants and personal fees from GlaxoSmithKline and Takeda; personal fees from AstraZeneca, Boehringer Ingelheim, Novartis, Zambon, and Recipharm; and non-financial support from Boehringer Ingelheim outside the submitted work. KC and EC-B are employees of Boehringer Ingelheim Pharmaceuticals, Inc. NM is an employee of Boehringer Ingelheim Pharma GmbH & Co KG. AA reports grants and personal fees from GlaxoSmithKline, and personal fees from AstraZeneca, Boehringer Ingelheim, and Novartis outside the submitted work. The authors report no other conflicts of interest in this work.
PY - 2018/2/14
Y1 - 2018/2/14
N2 - Background: Although COPD exacerbations are known to occur more frequently in winter, there is little information on hospitalizations and cause-specific mortality. This study aimed to examine seasonal variations in mortality and exacerbations in patients with COPD during the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial. Patients and methods: TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler® (18 μg once daily) or Respimat® Soft Mist™ (2.5 or 5 μg once daily) inhaler in patients with COPD. Patients were aged ≥40 years, with a smoking history ≥10 pack-years, and post-bronchodilator forced expiratory volume in 1 second ≤70% and forced expiratory volume in 1 second/forced vital capacity ≤0.70. COPD exacerbations and deaths were monitored throughout the trial. The data were pooled to examine seasonal patterns. Southern hemisphere data were shifted by 6 months to align with northern hemisphere seasons. Results: TIOSPIR was conducted in 43 northern (n=15,968) and 7 southern (n=1,148) hemisphere (n=1,148) countries. The median duration of treatment was 835 days, with a mean follow-up of 2.3 years. Among 19,494 exacerbations, there were clear seasonal differences (winter, 6,646 [34.1%]; spring, 4,515 [23.2%]; summer, 3,198 [16.4%]; autumn, 5,135 [26.3%]). Exacerbations peaked in early winter (December in the northern hemisphere and June in the southern hemisphere), respiratory hospitalizations in midwinter, and respiratory deaths in early spring. Conclusion: Although winter poses a 2-fold hazard for COPD exacerbations vs summer, respiratory deaths peak in early spring. These data suggest that seasonal intensification of preventive treatments may impact COPD morbidity and mortality. Trial registration number: NCT01126437.
AB - Background: Although COPD exacerbations are known to occur more frequently in winter, there is little information on hospitalizations and cause-specific mortality. This study aimed to examine seasonal variations in mortality and exacerbations in patients with COPD during the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial. Patients and methods: TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler® (18 μg once daily) or Respimat® Soft Mist™ (2.5 or 5 μg once daily) inhaler in patients with COPD. Patients were aged ≥40 years, with a smoking history ≥10 pack-years, and post-bronchodilator forced expiratory volume in 1 second ≤70% and forced expiratory volume in 1 second/forced vital capacity ≤0.70. COPD exacerbations and deaths were monitored throughout the trial. The data were pooled to examine seasonal patterns. Southern hemisphere data were shifted by 6 months to align with northern hemisphere seasons. Results: TIOSPIR was conducted in 43 northern (n=15,968) and 7 southern (n=1,148) hemisphere (n=1,148) countries. The median duration of treatment was 835 days, with a mean follow-up of 2.3 years. Among 19,494 exacerbations, there were clear seasonal differences (winter, 6,646 [34.1%]; spring, 4,515 [23.2%]; summer, 3,198 [16.4%]; autumn, 5,135 [26.3%]). Exacerbations peaked in early winter (December in the northern hemisphere and June in the southern hemisphere), respiratory hospitalizations in midwinter, and respiratory deaths in early spring. Conclusion: Although winter poses a 2-fold hazard for COPD exacerbations vs summer, respiratory deaths peak in early spring. These data suggest that seasonal intensification of preventive treatments may impact COPD morbidity and mortality. Trial registration number: NCT01126437.
KW - Exacerbations
KW - HandiHaler
KW - Preventive treatment
KW - Respimat Soft Mist inhaler
KW - Seasonality
KW - TIOSPIR
KW - Tiotropium
UR - http://www.scopus.com/inward/record.url?scp=85042373103&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85042373103&partnerID=8YFLogxK
U2 - 10.2147/COPD.S148393
DO - 10.2147/COPD.S148393
M3 - Article
C2 - 29497289
AN - SCOPUS:85042373103
VL - 13
SP - 605
EP - 616
JO - International Journal of COPD
JF - International Journal of COPD
SN - 1176-9106
ER -