Abstract Introduction Sleep disturbances are common among menopausal women with vasomotor symptoms (VMS). Elinzanetant has previously demonstrated patient-reported outcome (PRO) improvements in sleep disturbances in the OASIS studies. The Phase II NIRVANA trial further evaluated elinzanetant’s effect on sleep parameters using objectively-measured polysomnography (PSG), in addition to PROs. This abstract reports effect on PSG-measured wakefulness after sleep onset (WASO) at weeks 4 and 12. Methods NIRVANA included 110 menopausal women with PSG-measured WASO ≥30 minutes and ≥20 moderate-to-severe VMS/week, randomized to elinzanetant 120mg (n=55) or placebo (n=55) once daily for 12 weeks. In-lab PSG assessments occurred at baseline, week 4, and week 12 (two consecutive nights/time point). Primary and secondary endpoints were changes from baseline in WASO at weeks 4 and 12, respectively, analyzed using mixed model with repeated measures. A prespecified analysis with log transformation was applied; least squares geometric mean ratios (LSGMR) are reported. Post hoc random coefficient model was applied to all individual night data to assess overall treatment effect and account for night-to-night variability. Results Baseline median WASO was 72.0 minutes (quartile Q1, Q3: 48.0, 90.3) for elinzanetant and 76.8 minutes (Q1, Q3: 54.0, 102.5) for placebo. At week 4, LSGMR to baseline was 0.68 (unadjusted 90% confidence interval CI: 0.59, 0.77) for elinzanetant and 0.94 (0.82, 1.08) for placebo, representing a 28% (unadjusted 90% CI: 13%, 41%) greater reduction with elinzanetant. At week 12, LSGMRs were 0.67 (0.57, 0.79) for elinzanetant and 0.76 (0.65, 0.90) for placebo, representing a 12% (-11%, 30%) greater reduction with elinzanetant. Night-to-night variability was notable, with WASO differing by 60 minutes in 15% of consecutive nights. The random coefficient model showed an 18% (unadjusted 95% CI: 5%, 30%) greater WASO reduction with elinzanetant vs. placebo, equating to an absolute reduction of ~13 minutes across the 12-week treatment period (assuming a baseline of 75 minutes). Conclusion Elinzanetant had a numerically greater reduction in WASO vs. placebo, an effect more pronounced at week 4. The modest but relevant improvement supports the effect of elinzanetant on menopause-related sleep disturbances, consistent with PROs from the OASIS trials. Support (if any) Sponsored by Bayer. Medical writing assistance (Highfield, Oxford, UK) funded by Bayer.
Baker et al. (Fri,) studied this question.