The Food and Drug Administration (FDA) has approved the inclusion of new data from the ASCENT trial in the prescribing information for Tudorza Pressair (aclidinium bromide inhalation powder; Circassia), an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
In ASCENT, the effect of Tudorza on major adverse cardiovascular events (MACE) and COPD exacerbations was evaluated in 3630 patients with moderate to very severe COPD with and without a history of COPD exacerbations. All of the patients in the study had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
The primary safety endpoint of the study was the time to first occurrence of MACE (defined as cardiovascular death, non-fatal myocardial infarction [MI], or non-fatal ischemic stroke), while the primary efficacy measure was the rate of moderate to severe exacerbations during the first year of treatment (defined as worsening COPD symptoms for at least 2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or led to death).
Results showed that Tudorza Pressair was not associated with an increased risk of MACE compared with placebo (estimated hazard ratio 0.89 [95%, CI 0.64–1.23]); 3.9% of patients in the Tudorza Pressair group experienced at least 1 MACE vs 4.2% of the placebo group. The incidence rate of MACE was 2.4 per 100 patient-years on Tudorza Pressair compared with 2.8 per 100 patient-years on placebo.
As for the effect on COPD exacerbations, Tudorza Pressair demonstrated a statistically significant reduction in the rate of on-study moderate to severe COPD exacerbations during the first year by 17% vs placebo (rate ratio [RR] 0.83; 95%, CI 0.73–0.94; P=.003). In addition, a statistically significant reduction in the rate of on-study hospitalizations due to COPD exacerbations during the first year was observed with Tudorza Pressair compared with placebo (RR 0.72; 95% CI 0.55–0.95; P=.02).
“For a very long time, patients with a high cardiovascular risk were excluded from long-acting muscarinic antagonist (LAMA) trials, so we were unclear about the effect of LAMAs on cardiovascular disease; confidence has been low and questions about its safety have lingered,” said Kenneth Chapman, MD, Clinical Researcher, Krembil Research Institute, University Health Network, University of Toronto, and an investigator on the ASCENT trial. “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.”
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