Abstract
Background:Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects.Aims:The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg.Methods: A post hoc analysis of patients who were not receiving anticholinergics before TIOSPIR (N=6,966/17,135) was conducted. Primary end points were risk of death from any cause and risk of COPD exacerbation. Secondary outcomes included severe exacerbation and major adverse cardiovascular events (MACE). Additional analysis of exacerbations was carried out in anticholinergic-naive patients with moderate (GOLD II) disease.Results:Anticholinergic-naive patients had less severe disease than the total TIOSPIR population. Discontinuations because of anticholinergic side effects were infrequent (0.9% overall). Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. Risk of MACE was similar across the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups.Conclusions:Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy.
Highlights
Discontinuation attributed to anticholinergic side effects occurred in 0.7 and 1.0% of patients in the Respimat 2.5 and 5 μg groups, respectively, and 0.9% of patients in the HandiHaler group
Of the patients who reported symptoms of breathlessness (n = 6,688; 96.1%), the majority were classified as modified Medical Research Council scale 1 (n = 2,694, 40.3%) or scale 2 (n = 2,486, 37.2%) (Table 1)
The present study showed that patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergic treatment at baseline, and who were treated with Respimat 2.5 or 5 μg, were at a similar risk of mortality and adverse cardiac events as patients receiving HandiHaler 18 μg
Summary
Tiotropium (SPIRIVA, Boehringer Ingelheim Pharma & Co KG, Ingelheim am Rhein, Germany) is a once-daily, long-acting, anticholinergic bronchodilator available in two formulations: dry powder via HandiHaler (18 μg once daily) and as an aqueous solution via the Respimat Soft Mist Inhaler (5 μg (two puffs of 2.5 μg once daily)).[1,2] Tiotropium HandiHaler 18 μg and tiotropium Respimat 5 μg have demonstrated similar improvements in lung function, symptoms and quality of life[3,4,5,6] and have similar pharmacokinetic profiles in patients with chronic obstructive pulmonary disease (COPD).[7]Queries around the safety of Respimat[8,9,10] were addressed in the TIOtropium Safety and Performance In Respimat (TIOSPIR; NCT01126437) trial11—the largest long-term, randomised, doubleblind trial in patients with COPD performed to date. Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. AIMS: The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg. Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. CONCLUSIONS: Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy
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