Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials

Ferguson, Gary T.; Buhl, Roland; Bothner, Ulrich; Hoz, Alberto de la; Voß, Florian; Anzueto, Antonio; Calverley, Peter M.A.

doi:10.1016/j.rmed.2018.08.012

Cited by 20 publications

(28 citation statements)

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“…The safety data show a slightly higher proportion of patients with adverse events in the tiotropium/olodaterol period compared with the tiotropium period, but this was a small population and a relatively short trial. A large safety database of longer-term and larger trials has shown that there is no difference between tiotropium/olodaterol and tiotropium in the proportion of patients with adverse events [32, 33].…”

Section: Discussionmentioning

confidence: 99%

Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

Maltais

Aumann²,

Kirsten

et al. 2019

Eur Respir J

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The 3-min constant speed shuttle test (CSST) was used to examine the effect of tiotropium/olodaterol compared with tiotropium at reducing activity-related breathlessness in patients with chronic obstructive pulmonary disease (COPD).This was a randomised, double-blind, two-period crossover study including COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8. Patients received 6 weeks of tiotropium/olodaterol 5/5 µg and tiotropium 5 µg in a randomised order with a 3-week washout period. The speed for the 3-min CSST was determined for each patient such that an intensity of breathing discomfort ≥4 (“somewhat severe”) on the modified Borg scale was reached at the end of a completed 3-min CSST.After 6 weeks, there was a decrease in the intensity of breathlessness (Borg dyspnoea score) at the end of the 3-min CSST from baseline with both tiotropium (mean –0.968, 95% CI −1.238– −0.698; n=100) and tiotropium/olodaterol (mean −1.325, 95% CI −1.594– −1.056; n=101). The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol versus tiotropium (treatment difference −0.357, 95% CI −0.661– −0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.

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Section: Discussionmentioning

confidence: 99%

Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

Maltais

Aumann²,

Kirsten

et al. 2019

Eur Respir J

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“…Safety data from the pooled population have been published previously [18]. In brief, the proportion of patients discontinuing treatment was lower with tiotropium/olodaterol (12.5%) compared with tiotropium (16.4%).…”

Section: Safetymentioning

confidence: 95%

Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials

et al. 2020

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Introduction: Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. Methods: This post hoc analysis pooled data from TONADO Ò 1 ? 2 and DYNAGITO Ò , three 52-week, parallel-group, randomised, doubleblind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 lg or tiotropium 5 lg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. Results: In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; Digital Features To view digital features for this article go to

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“…In a pooled analysis of data from three 52-week trials (TOnado 1 and 2 and DYNAGITO), the rate of AEs per 100 patient-years (PY) was 152.66 with tiotropium/olodaterol and 158.33 with tiotropium (exposure-adjusted RR 0.96; 95% CI 0.92–1.01) [34]. There were 22.16 and 24.22 SAEs per 100 PY with tiotropium/olodaterol and tiotropium (RR 0.91; 95% CI 0.84–1.00).…”

Section: Tolerability Of Tiotropium/olodaterolmentioning

confidence: 99%

Tiotropium/Olodaterol: A Review in COPD

Blair

2019

Drugs

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Tiotropium/olodaterol (Stiolto ® Respimat ® ; Spiolto ® Respimat ® ) is an inhaled fixed-dose combination of the long-acting muscarinic antagonist tiotropium bromide (hereafter referred to as tiotropium) and the long-acting β 2 -adrenergic agonist olodaterol. It is available in several countries, including the USA, Japan, China and those of the EU, where it is indicated for the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The efficacy of tiotropium/olodaterol 5/5 μg/day in patients with COPD was evaluated in phase III or IV trials of 6–52 weeks’ duration. Tiotropium/olodaterol improved lung function to a greater extent than each of its individual components or placebo in 12- and 52-week trials. In 6-week trials, tiotropium/olodaterol provided greater lung function benefits over 24 h than the individual components, placebo or twice-daily fluticasone propionate/salmeterol. Tiotropium/olodaterol also demonstrated beneficial effects on health-related quality of life (HR-QoL), dyspnoea, inspiratory capacity, exercise endurance and the need for rescue medication. In an 8-week open-label trial, umeclidinium/vilanterol was superior to tiotropium/olodaterol for the primary endpoint of trough forced expiratory volume in 1 s. The tolerability profile of tiotropium/olodaterol was generally similar to that of the individual components. In conclusion, tiotropium/olodaterol provides a useful option for the maintenance treatment of COPD, with the convenience of once-daily administration via a single inhaler.

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Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials

Abstract: clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

Cited by 20 publications

References 19 publications

Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials

Tiotropium/Olodaterol: A Review in COPD

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