Aclidinium (Tudorza, Circassia Pharma) reduced acute exacerbations of COPD but did not increase risk of major adverse cardiovascular events, according to a study published in JAMA.
Tudorza Pressair (aclidinium bromide inhalation powder) received an expanded approval to treat AECOPD in April 2019.
Researchers conducted a multicenter, randomized, placebo-controlled, double-blind, parallel-design study of patients with moderate to very severe COPD and either a history of cardiovascular disease or at least 2 atherothrombotic risk factors.
As part of the study, 3,630 patients were randomized to receive aclidinium or placebo by dry-powder inhaler, twice daily for up to 3 years.
Of the 2,537 patients who completed the study, 3.9% treated with aclidinium and 4.2% treated with placebo had a MACE (? = .03).
Annual moderate to severe exacerbation rates (aclidinium 0.44 vs placebo 0.57) and rate of exacerbations requiring hospitalization (aclidinium 0.07 vs placebo 0.10) decreased significantly with aclidinium vs placebo.
“Among patients with COPD and increased cardiovascular risk, aclidinium was noninferior to placebo for risk of MACE over 3 years” and reduced AECOPD researchers concluded.