Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial

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. 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. 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. 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. Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy. Inhaled forms of the drug tiotropium are safe and effective for patients with chronic lung disease. Breathing difficulties caused by chronic obstructive pulmonary disease (COPD) can be treated using the 'anticholinergic' drug tiotropium, which works by enlarging the patient's airways. Tiotropium is available as a dry powder or aqueous solution inhaler. The inhaler was recently confirmed as safe in randomized trials, however, there were concerns that the trials did not verify safety and efficacy for patients new to anticholinergic therapy. Robert Wise at Johns Hopkins University School of Medicine in Baltimore, USA, and co-workers tested two inhaled forms of tiotropium on 6,966 COPD patients new to anticholinergics. Their results indicated both inhalers were effective and presented low risks of death, heart problems or other side effects, regardless of previous exposure to anticholinergics.