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August 22, 2024 – Elinzanetant, a novel therapeutic agent, has demonstrated substantial efficacy in reducing the frequency and severity of vasomotor symptoms associated with menopause. According to the latest phase 3 trials, the medication significantly improved menopausal symptoms, sleep disturbances, and overall quality of life for women experiencing moderate to severe symptoms.
Study Overview
The findings are based on two randomized, double-blind, placebo-controlled phase 3 trials known as OASIS 1 and OASIS 2. Conducted across 77 sites in the US, Europe, Canada, and Israel, the trials involved 796 postmenopausal women aged 40 to 65 years who were experiencing moderate to severe vasomotor symptoms. Participants were administered either 120 mg of elinzanetant or a placebo once daily for 12 weeks, followed by an additional 14 weeks of elinzanetant.
Key Results
Elinzanetant exhibited a remarkable impact on vasomotor symptoms:
- By week 4, the frequency of vasomotor symptoms was significantly reduced (OASIS 1: -3.3, 95% CI, -4.5 to -2.1; OASIS 2: -3.0, 95% CI, -4.4 to -1.7; P < .001).
- This reduction persisted through week 12 (OASIS 1: -3.2, 95% CI, -4.8 to -1.6; OASIS 2: -3.2, 95% CI, -4.6 to -1.9; P < .001).
In addition to alleviating vasomotor symptoms, elinzanetant significantly improved sleep disturbances, with reductions in the PROMIS Sleep Disturbance–Short Form 8b total T scores (OASIS 1: -5.6, 95% CI, -7.2 to -4.0; OASIS 2: -4.3, 95% CI, -5.8 to -2.9; P < .001). Menopause-related quality of life also saw notable improvements, as evidenced by reductions in the MENQOL total scores (OASIS 1: -0.4, 95% CI, -0.6 to -0.2; OASIS 2: -0.3, 95% CI, -0.5 to -0.1; P = .0059).
Clinical Implications
These results underscore the potential of elinzanetant as a transformative treatment for menopausal symptoms. The study authors highlight the clinical relevance of these findings, noting that vasomotor symptoms can significantly affect overall health, daily activities, sleep, quality of life, and work productivity.
Study Limitations
Despite the promising results, there are some limitations to consider. The trials focused exclusively on postmenopausal individuals, which may limit the generalizability of the findings to other populations. Additionally, the reliance on patient-reported outcomes introduces the possibility of subjective bias. The placebo response observed in these trials is consistent with previous studies on vasomotor symptoms, which could impact result interpretation. Further research is needed to evaluate the long-term safety and efficacy of elinzanetant beyond the 26-week treatment period.
Disclosure
The trials were led by JoAnn V. Pinkerton, MD, MSCP, from the University of Virginia Health, and James A. Simon, MD, MSCP, from George Washington University. The study was published online in JAMA on August 22. Pinkerton received grants from Bayer Pharmaceuticals and consulting fees from Bayer Pharmaceutical, while Simon disclosed grants and personal fees from multiple organizations, including Bayer Healthcare and AbbVie.
For further details, refer to the original publication in JAMA.
