The US FDA has expanded Tudorza Pressair’s (aclidinium bromide inhalation powder) approval to include data on its ability to reduce acute exacerbations of COPD (AECOPD).
The data, which was from the ASCENT trial, also indicates the drug does not increase major adverse cardiovascular events for COPD patients with cardiovascular disease and/or significant cardiovascular risk factors, according to manufacturer Circassia Pharma.
“It was essential to answer the question about major adverse cardiovascular events and safety in COPD patients with cardiovascular co-morbidity,” said Michael Asmus, vice president, US Medical Affairs, Circassia. “The inclusion of the ASCENT safety information in the updated Tudorza Pressair label addresses that question.”
ASCENT was a phase IV randomized, double-blind, placebo-controlled of up to 36-months study that evaluated the effect of Tudorza Pressair on major adverse cardiovascular events and exacerbations in 3,630 patients with moderate-to-very-severe COPD. All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
Researchers found that, compared to placebo, Tudorza Pressair does not increase major adverse cardiovascular events and reduced exacerbations in the first year in COPD patients with high cardiovascular risk, according to data cited by Circassia.
Adverse reactions occurred at a rate of ?2% and more common than placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and GERD, Circassia reported.
“Most people who have COPD are also at a higher risk for cardiovascular disease because the most common cause of COPD is long-term smoking,” said Kenneth Chapman, MD, a clinical researcher at University of Toronto and investigator on the ASCENT trial. “For a very long time, patients with a high cardiovascular risk were excluded from LAMA trials, so we were unclear about the effect of LAMAs on cardiovascular disease.
“ASCENT showed that Tudorza Pressair use led to clear and consistent reduction in exacerbations and reductions in flare-ups. This leads to lower emergency room visits and lower hospital admissions.”