Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD

Abstract

BACKGROUND Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-tovery-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β 2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β 2-agonist salmeterol in preventing exacerbations of COPD. METHODS In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year. RESULTS A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P = 0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group. CONCLUSIONS These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.

Chronic Obstructive Pulmonary Disease: Official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care

“…Available treatment guidelines describe the use of long-acting inhalation drugs (twice daily: long-acting muscarinic antagonist (LAMA) -aclidinium, long-acting beta2-adrenoreceptor agonist (LABA) -formoterol, salmeterol and once daily: ultra-long-acting muscarinic antagonist (U-LAMA) -tiotropium, glycopyrronium, umeclidinium and ultralong-acting beta2-adrenoreceptor agonist (U-LABA) -indacaterol, olodaterol, vilanterol) in symptomatic patients with post-BD FEV 1 60-80% of the predicted value, and these are highly recommended in symptomatic patients with post-BD FEV 1 <60% of the predicted value 1 . The choice of specific agent depends on the physician, or patient's preference 1,2,4,58,59, [64][65][66][67][68][69][70][71][72][73] .…”

A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations

“…A COPD exacerbation is defined as a sustained worsening of the patient's condition (dyspnoea, cough and/or sputum production/purulence) from the stable state and beyond normal dayto-day variations that is acute in onset and requires unscheduled medical intervention, leading to prescriptions of systemic corticosteroids and/or antibiotics or the need for a visit to an emergency department or hospitalisation [23]. The physiciandiagnosed COPD exacerbations that fit the above criteria, corresponding to HealthCare Resource Utilisation (HCRU) exacerbations, will be used for the analysis of the exacerbation rate as the co-primary end-point.…”

Cardiovascular safety of new inhaled medications for asthma and chronic obstructive pulmonary disease: a critical review from pharmacist perspective

“…11 Despite the large sample size, a study by Vogelmeier C et al did not report any incidences of cardiac AEs, whereby there was no mention of ECG use or vital signs assessment. 48 The evidence to date suggested that the use of LABA is relatively safe and effective for asthma and COPD patients. 3,9,29,31 But, few studies have included subjects with both asthma and COPD co-morbidity, or subjects with significant CVD co-morbidities.…”