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On April 18, 2025, we reported on pooled data from the phase 3 OASIS-1 and OASIS-2 clinical trials presented at the 2025 Academy of Managed Care Pharmacy Annual Meeting that aimed to determine the effectiveness of elinzanetant in prespecified body mass index (BMI) and smoking history subgroups.
The study
Participants in both the elinzanetant and placebo groups were evaluated by BMI, with 4 classifications, measured in kg/m2: BMI of less than 18.5 (n = 5 and n = 2, respectively), BMI of 18.5 to 25 (n = 124 and n = 118, respectively), BMI of 25 to 30 (n = 142 and n = 143, respectively), and BMI of 30 or higher (n = 128 and n = 134, respectively). They were also classified into 3 smoking history groups: never (n = 267 and n = 250, respectively), former (n = 67 and n = 66, respectively), and current (n = 65 and n = 81, respectively).
The findings
Overall, elinzanetant consistently reduced daily hot flash frequency across BMI categories and smoking statuses at 12 weeks. Women with a BMI of 30 or higher experienced a mean (SD) VMS reduction of 9.7 (11.5) episodes per day with elinzanetant vs a reduction of 5.2 (11.5) with placebo. Those with a BMI of 18.5 to 25 experienced reductions of 8.8 (7.1) VMS episodes per day with elinzanetant vs 6.5 (6.3) with placebo, and the group with a BMI of 25 to 30 experienced reductions of 9.5 (6.8) vs 7.4 (9.2), respectively.
In the smoking status subgroups, the most significant benefit was seen among current smokers, who experienced a reduction of 11.2 (12.2) VMS episodes with elinzanetant vs a reduction of 7.4 (9.2) with placebo. VMS episodes were reduced by 7.8 (6.4) vs 5.4 (6.2) per day among former smokers treated with elinzanetant and placebo, respectively, and never smokers experienced reductions of 9.3 (8.1) vs 6.4 (10.1), respectively.
Authors' comments
"[Elinzanetant] demonstrated greater numerical reductions than [placebo] in moderate-to-severe VMS frequency in postmenopausal women across all BMI and smoking history subgroups."
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