Introduction
This post hoc analysis investigated quality of life (QoL) by menopausal status in the STEP and OASIS 4 trials.
Methods
Female participants (pts) with body mass index ≥30 kg/m2, or ≥27 kg/m2 with ≥1 obesity-related complications who received once-weekly subcutaneous semaglutide 2.4 mg for 68 weeks (wk) in STEP 1, 3, 4, and 9, or once-daily oral semaglutide 25 mg for 64 wk in OASIS 4, were stratified by menopausal status. Changes from baseline (BL) were assessed for Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT; STEP 1, OASIS 4), Short Form-36v2 Health Survey acute version (SF-36v2; STEP 1, 3, 4), International Consultation of Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF; STEP 1), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; STEP 9). Safety was also assessed.
Results
Analysis included pre-menopause (n=785), peri-menopause (n=373), post-menopause, (n=768) from the STEP trials and n=68; n=33; and n=50, respectively, from OASIS 4. In STEP 1, mean IWQOL-Lite-CT Physical Function composite scores improved across all groups (pre- +15.6 [BL 68.1], peri- +15.9 [63.5], post- +15.8 [61.5]); OASIS 4 (pre- +16.0 [BL 58.2], peri- +21.8 [54.2], post- +17.6 [55.7]). In STEP 1, 3, and 4, SF-36v2 Physical Component Summary scores improved (pre- +3.0 [BL 52.3]; peri- +2.5 [51.6]; post- +2.6 [50.4]). In STEP 1, the proportion of pts reporting ≤1 urinary incontinence episode/wk at wk 68 was lowest in the post-menopause group (35.6% vs pre- 41.5%, peri- 40.9%). In STEP 9, more pts in the post-menopause group achieved ≤−37.3 from BL in WOMAC pain score (69.5%) (pre- 50.0%; peri- 53.6%). The safety of semaglutide was consistent across groups; most adverse events were gastrointestinal.
Conclusion
Semaglutide was associated with clinically meaningful improvements in weight-related QoL, regardless of menopausal status, in women with overweight/obesity in the STEP and OASIS 4 trials.