Lemborexant appears safe in adult, older patients with moderate to severe COPD

NASHVILLE, Tenn. — In a cohort of adult and older patients with moderate to severe COPD, 10 mg of lemborexant was associated with respiratory safety after single and multiple dosing, concluded data presented at CHEST Annual Meeting.

This makes lemborexant (Dayvigo, Eisai), a drug approved in multiple countries for the treatment of adults with insomnia, the first dual orexin receptor antagonist to establish respiratory safety in severe COPD, according to researchers.

“Lemborexant 10 mg [LEM10] was well tolerated overall, and treatment-emergent adverse events were mostly mild, and consistent with the known safety profile of lemborexant,” Jocelyn Y. Cheng, MD, senior director in clinical research, neurology, at Eisai Inc., told Healio.

The multicenter, randomized, double-blind, placebo-controlled, two-period crossover study featured adult (aged 45 to < 65 years) and older (aged 65 to 90 years) patients with moderate to severe COPD and no clinically important obstructive sleep apnea.

Researchers screened patients for COPD severity by spirometry performed based on Global Initiative for Obstructive Lung Disease recommendations and randomly assigned them to two 8-night treatment periods with LEM10 or placebo, with treatment periods separated by a washout of at least 14 days.

In all, 30 patients (mean age, 69.2 years; 30% men) — 25 with moderate and five with severe COPD — were included, with 23.3% of patients in the adult group and 76.7% in the older group.

Results indicated that during total sleep time at screening, the mean baseline peripheral oxygen saturation (SpO²) was 91.6% and apnea-hypopnea index (AHI) was 4.6.

The least squares mean (LSM) difference for SpO² was –0.43 on day 1 (single dosing), which failed to reach statistical significance, whereas the difference was 0.47 on day 8 (multiple dosing), which did reach statistical significance (P = .022) in favor of LEM10.

For AHI, the LSM difference was 1.47 on day 1 and 0.24 on day 8, neither of which reached statistical significance.

Researchers also noted that lemborexant was well tolerated and that treatment-emergent adverse events were mostly mild in severity and consistent with the known safety profile.

“In adult and elderly subjects with moderate to severe COPD, single and multiple doses of LEM10 did not adversely affect SpO² and AHI compared to placebo,” Cheng said. “Specifically, SpO² was not significantly different for LEM10 vs. placebo after single dosing, and was statistically significantly different after multiple dosing, favoring LEM10, while AHI was not significantly different for LEM10 vs. placebo after single or multiple doses.”

Cheng added that the data suggest that lemborexant may be a treatment option for patients with insomnia and COPD, including the older population.

“Of note, this is the first dual orexin receptor antagonist to establish respiratory safety in individuals with severe COPD,” she said.

Reference:

Anderson G, et al. Chest. 2022;doi:10.1016/j.chest.2022.08.2138.