PMID- 33277507
OWN - NLM
STAT- MEDLINE
DCOM- 20210922
LR  - 20210922
IS  - 2055-1010 (Electronic)
IS  - 2055-1010 (Linking)
VI  - 30
IP  - 1
DP  - 2020 Dec 4
TI  - Long-term safety of tiotropium/olodaterol in older patients with 
      moderate-to-very-severe COPD in the TONADO(R) studies.
PG  - 53
LID - 10.1038/s41533-020-00212-w [doi]
LID - 53
AB  - Older patients with chronic obstructive pulmonary disease (COPD) may be at 
      increased risk of adverse events (AEs) due to decreased protective organ function 
      and increased comorbidities. TONADO(R) 1 + 2 were replicate, randomized, 
      double-blind, parallel-group, 52-week, Phase III trials comparing the efficacy 
      and safety of tiotropium/olodaterol (5/5 microg) versus the monocomponents via the 
      Respimat(R) inhaler in patients with moderate-to-very-severe COPD. In this 
      prespecified safety analysis, patients were grouped by age. Of 3100 patients, 
      1585 (51.1%) were aged <65 years, 1198 (38.7%) 65-<75 years, 309 (10.0%) 75-<85 
      years, and eight (0.3%) >/=85 years. At baseline, 23.4% had a pre-existing cardiac 
      disorder, 45.6% had hypertension, and 13.3% had glucose metabolism disorders, 
      including diagnosed diabetes. Overall, there was no increase in major adverse 
      cardiac events, other AEs, or serious AEs with tiotropium/olodaterol versus the 
      monocomponents in any age group, supporting the safety of tiotropium/olodaterol 
      in older patients with COPD.
FAU - Ferguson, Gary T
AU  - Ferguson GT
AUID- ORCID: 0000-0002-3277-4110
AD  - Pulmonary Research Institute of Southeast Michigan, 29255 West 10 Mile Road, 
      Suite A, Farmington Hills, MI, 48336, USA. garytferguson@msn.com.
FAU - Maltais, Francois
AU  - Maltais F
AD  - Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de 
      Quebec, Universite Laal, 2725 Chemin Sainte-Foy, Quebec City, QC, G1V 4G5, 
      Canada.
FAU - Karpel, Jill
AU  - Karpel J
AD  - North Shore Medical Arts LLP, 295 Community Drive, Great Neck, New York, NY, 
      11021, USA.
FAU - Bothner, Ulrich
AU  - Bothner U
AUID- ORCID: 0000-0001-6515-0841
AD  - Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim 
      am Rhein, Germany.
FAU - Kloer, Isabel
AU  - Kloer I
AD  - Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim 
      am Rhein, Germany.
FAU - Trampisch, Matthias
AU  - Trampisch M
AD  - Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim 
      am Rhein, Germany.
FAU - Buhl, Roland
AU  - Buhl R
AD  - Pulmonary Department, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, 
      D-55131, Mainz, Germany.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201204
PL  - England
TA  - NPJ Prim Care Respir Med
JT  - NPJ primary care respiratory medicine
JID - 101631999
RN  - 0 (Benzoxazines)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (tiotropium-olodaterol)
RN  - XX112XZP0J (Tiotropium Bromide)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzoxazines/adverse effects/*therapeutic use
MH  - Bronchodilator Agents/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/pathology
MH  - Severity of Illness Index
MH  - Tiotropium Bromide/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC7719164
COIS- G.T.F. has received grants, personal fees, and non-financial support from 
      Boehringer Ingelheim, Novartis, AstraZeneca, Pearl Therapeutics, and Sunovion; 
      grants and personal fees from Theravance; and personal fees from Verona, Mylan, 
      Innoviva, GlaxoSmithKline, and Circassia outside the submitted work. F.M. 
      received fees for speaking at conferences sponsored by Boehringer Ingelheim, 
      Novartis, and Grifols; research grants for participating in multicenter trials 
      sponsored by GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis; 
      and unrestricted research grants from Boehringer Ingelheim, Novartis, and 
      Grifols. He also holds a CIHR/GlaxoSmithKline research chair on COPD. J.K. has 
      nothing to disclose. U.B., I.K., and M.T. are employees of Boehringer Ingelheim. 
      R.B. has received grants and personal fees from Boehringer Ingelheim, 
      GlaxoSmithKline, Novartis, and Roche; and personal fees from AstraZeneca, Chiesi, 
      Cipla, and Teva. The authors received no compensation related to the development 
      of the manuscript.
EDAT- 2020/12/06 06:00
MHDA- 2021/09/23 06:00
PMCR- 2020/12/04
CRDT- 2020/12/05 05:28
PHST- 2020/07/14 00:00 [received]
PHST- 2020/11/03 00:00 [accepted]
PHST- 2020/12/05 05:28 [entrez]
PHST- 2020/12/06 06:00 [pubmed]
PHST- 2021/09/23 06:00 [medline]
PHST- 2020/12/04 00:00 [pmc-release]
AID - 10.1038/s41533-020-00212-w [pii]
AID - 212 [pii]
AID - 10.1038/s41533-020-00212-w [doi]
PST - epublish
SO  - NPJ Prim Care Respir Med. 2020 Dec 4;30(1):53. doi: 10.1038/s41533-020-00212-w.