(150) Efficacy of elinzanetant in previous or never users of HT: pooled analysis

Background: : The Phase 3 OASIS-1 and -2 studies evaluated the effects of elinzanetant (EZN) on vasomotor symptoms (VMS) and sleep disturbances in menopausal women.

Objective: : Pooled post hoc analysis from these studies comparing the effects of EZN on VMS and sleep disturbances in menopausal women who were either previous (pHT) or never (nHT) users of menopausal hormone therapy.

Methods: : The trials included naturally/surgically postmenopausal women aged 40–65 years with ≥50 moderate-to-severe VMS/week who were randomized 1:1 to receive EZN 120 mg for 26 weeks or placebo for 12 weeks, followed by EZN for 14 weeks.
Participants completed a hot flash daily diary recording VMS frequency and severity (categorized as: mild: sensation of heat without sweating; moderate: sensation of heat with sweating but able to continue activity; or severe: sensation of heat with sweating causing cessation of daily activity). Mean frequency and severity of VMS for each week was calculated using available data during that week and averaged to a mean daily frequency/daily severity, with baseline calculated from the 14 days before start of treatment.
Sleep disturbance was assessed using Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b); item scores were summed to give total raw scores then converted to total T-scores (higher scores indicate greater sleep disturbance).
Outcomes were assessed at baseline and weeks 1, 4, 8, and 12, stratified by pHT and nHT.

Results: : Overall, 226 women were pHT and 546 women were nHT.
Baseline mean (standard deviation) VMS frequency ranged from 13.90 (7.57) to 15.44 (10.74) across groups receiving either EZN or placebo. At week 12, EZN reduced mean VMS frequency to 4.20 (4.07) in pHT and 4.68 (6.00) in nHT compared with placebo reductions to 8.50 (7.33) and 9.17 (14.52), respectively.
VMS severity ratings ranged from 2.52 (0.24) to 2.56 (0.24) at baseline. At week 12, EZN reduced VMS severity ratings to 1.66 (0.82) in pHT and 1.54 (0.83) in nHT compared with placebo reductions to 2.00 (0.65) and 1.90 (0.69), respectively.
Baseline PROMIS SD SF 8b total T-scores ranged from 60.05 (6.99) to 61.64 (6.63). At week 12, EZN reduced scores to 49.41 (9.20) in pHT and 51.16 (7.90) in nHT compared with placebo reductions to 56.20 (8.11) and 54.51 (8.32), respectively.

Conclusions: : EZN reduced VMS frequency and severity and improved sleep disturbances compared with placebo to a similar extent in both pHT and nHT, supporting its suitability for menopausal symptom management irrespective of prior hormone therapy use.

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