Head-to-Head Study Results About Two COPD Inhalers Gives One an Edge

A study of 2 chronic obstructive pulmonary disease (COPD) inhalers from the same company was published recently in The Lancet Respiratory Medicine. The DYNAGITO trial showed tiotropium bromide and olodaterol, a dual bronchodilator sold under the name Stiolto Respimat, prevented exacerbations better than tiotropium bromide alone (sold as Spiriva Respimat), although not quite as much as expected.

The worldwide, 52-week study involved 7880 patients. The mean age was 66.4 years and 71% were men. The mean forced expiratory volume in 1 second (FEV₁) was 44.5%.

Of those patients, 3939 received tiotropium—olodaterol and 3941 tiotropium. The rate of moderate and severe exacerbations was 7% lower with tiotropium–olodaterol than tiotropium alone (rate ratio [RR] 0.93, 99% CI 0.85–1.02; P = 0.0498), not meeting the targeted 0.01 significance level set in the study. There was a small difference between treatment groups that met the conventional 5% significance level.

The proportion of patients reporting adverse events was similar between treatments.

"Exacerbations can have a significant negative impact on people with COPD because they can cause permanent lung damage and possibly lead to lengthy hospitalizations or even death. Therefore, COPD treatment strategies should include steps to reduce the risk of exacerbations," Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas Health Science Center at San Antonio, who served as an investigator and co-author for DYNAGITO, said in a statement provided by Boehringer Ingelheim, which makes both treatments. "Because exacerbations can cause COPD to progress more quickly, studies such as DYNAGITO are important to understand how medicines can help prevent exacerbations from affecting patients."

COPD exacerbations were defined as an increase or new onset of at least 2 of the following symptoms: shortness of breath, sputum production, change in sputum color, cough, wheezing, or chest tightness, for a duration of at least 3 days.

Current clinical treatment guidelines for patients with COPD at high risk of exacerbations recommend the combination of a long-acting beta2-agonist (LABA) with an inhaled glucocorticoid (also called an inhaled corticosteroid) or a long-acting muscarinic antagonist monotherapy as first-line therapy.

The study also showed that tiotropium—olodaterol, a LABA, significantly reduced COPD symptoms and improved quality of life, as measured by the COPD Assessment Test, compared with tiotropium.

Reference

Calverley PMA, Anzueto AR, Carter K, et al. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. [published online March 28, 2018]. Lancet Respir Med. http://dx.doi.org/10.1016/S2213-2600(18)30102-4.