Long-term safety of tiotropium/olodaterol in older patients with moderate-to-very-severe COPD in the TONADO® studies.

Abstract

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® 1 + 2 were replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials comparing the efficacy and safety of tiotropium/olodaterol (5/5 µg) versus the monocomponents via the Respimat® 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.

• Authors: Gary T Ferguson, François Maltais, Jill Karpel, Ulrich Bothner, Isabel Kloer, Matthias Trampisch, Roland Buhl
• Journal: NPJ primary care respiratory medicine (NPJ Prim Care Respir Med) Vol. 30 Issue 1 Pg. 53 (12 04 2020) ISSN: 2055-1010 [Electronic] England
• PMID: 33277507 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzoxazines
• Bronchodilator Agents
• Drug Combinations
• tiotropium-olodaterol
• Tiotropium Bromide

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Benzoxazines (adverse effects, therapeutic use)
• Bronchodilator Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (drug therapy, pathology)
• Severity of Illness Index
• Tiotropium Bromide (adverse effects, therapeutic use)
• Treatment Outcome