LAMA Appears Safe for COPD Patients With Recent Exacerbations

Allergies & Asthma

NEW ORLEANS — In a subgroup analysis of the ASCENT-COPD trial results, use of the long-acting inhaled muscarinic antagonist (LAMA) aclidinium bromide (Tudorza) was associated with a reduced risk for exacerbations and a similar safety profile in patients with and without a recent history of exacerbations.

Original findings from the trial, published last spring, showed treatment with the LAMA to be associated with reduced COPD exacerbations with no increase in major adverse cardiovascular events (MACE) over three years, compared to placebo, in patients at increased risk for cardiovascular events.

The subgroup data — reported here at the CHEST annual meeting by Robert Wise, MD, of Johns Hopkins University in Baltimore — confirmed the earlier safety findings in COPD patients with and without recent exacerbations.

Wise told MedPage Today that the latest findings “provide reassurance” regarding the efficacy and safety of long-acting anticholinergic therapy in COPD patients.

“What we found, which was interesting and perhaps a little surprising, was that proportional reduction in exacerbations was similar in the two populations,” Wise told MedPage Today. “The proportional reduction was, in fact, a little better in the non-exacerbating group.”

The 3,589 participants in the phase IV ASCENT-COPD trial were randomized 1:1 to receive either aclidinium bromide or placebo for up to three years, with COPD exacerbation rates monitored for the first year of the trial. Cardiovascular events and all-cause mortality were assessed over three years.

The study was originally designed to include only patients who had experienced one exacerbation or more in the year prior to enrollment, but this was changed in the trial’s second year to allow patients without recent exacerbations.

At the end of recruitment a total of 2,156 patients had experienced recent exacerbations and 1,433 had no exacerbations in the year prior to enrollment.

The two groups were similar in terms of key characteristics, including age, sex, smoking status, total CAT score and mean post-bronchodilator FEV1.

Not surprisingly, the rate of exacerbations, and the percentage of patients with MACE were higher in the recent-exacerbation group.

But reductions in exacerbation rates were seen with aclidinium relative to placebo irrespective of patients’ previous exacerbation history.

No statistically significant increase in MACE was seen for aclidinium versus placebo in either group, and the drug was not associated with increased all-cause mortality (recent exacerbation group: 9.3% in aclidinium group and 8.6% in placebo group; no recent exacerbation: 2.4% and 3.5%, respectively; HR 0.66, 95% CI 0.36-1.22).

Darcy Marciniuk, MD, of the University of Saskatchewan, who was not involved with the study, told MedPage Today the findings from the subgroup analysis should be considered reassuring.

“There has been concern in the past about whether this group of bronchodilators is safe for people with COPD who also have comorbidities,” he told MedPage Today. “To date, the data have reassured us that they are. ASCENT was a large trial with a 3-year follow-up period. In this analysis, I think they have confirmed with some certainty that this bronchodilator aclidinium probably does not increase the risk for cardiovascular mortality or pose any other risk, and this probably extends to the [LAMA] class of medications.”

Lead researcher Robert A. Wise reported receiving personal fees from AstraZeneca, Pulmonx, Novartis, Boehringer Ingelheim, GlaxoSmithKline, and others.

The ASCENT-COPD trial was funded by AstraZeneca and Circassia.


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