The FDA recently approved the first long-acting beta agonist and a long-acting muscarinic antagonist (LABA/LAMA) — umeclidinium/vilanterol (Anoro Ellipta) — for chronic obstructive pulmonary disease.
Despite questions about potential cardiovascular risks with LAMAs, the agency approved the combination medication, citing “very strong” efficacy results from two placebo-controlled and two active-controlled clinical trials.
Now safety data from one of the two placebo-controlled clinical trials of umeclidinium/vilanterol has recently been published in the journal Chest. That data indicate no new safety signals, and an overall similar incidence of treatment-emergent adverse events compared with placebo.
“[C]ardiovascular effects were closely monitored in the present study,” Bartolome Celli, MD, of Brigham and Women’s Hospital in Boston, and colleagues wrote. “No clinically meaningful effects were observed in vital signs and [EKG] assessments for any active treatment and the incidences of LAMA- and LABA-associated adverse events were low.”
Overall, there was one death attributable to myocardial infarction in the study population, and the event was not considered drug related.