User login
Elinzanetant Reduces Menopausal Symptoms
TOPLINE:
. The drug also improved sleep disturbances and menopause-related quality of life, with a favorable safety profile.
METHODOLOGY:
- Researchers conducted two randomized, double-blind, placebo-controlled phase 3 trials (OASIS 1 and 2) across 77 sites in the United States, Europe, Canada, and Israel.
- A total of 796 postmenopausal participants aged 40-65 years experiencing moderate to severe vasomotor symptoms were included.
- Participants received either 120 mg of elinzanetant or a placebo once daily for 12 weeks, followed by elinzanetant for an additional 14 weeks.
- Primary outcomes measured were changes in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12, using an electronic hot flash daily diary.
- Secondary outcomes included changes in sleep disturbances and menopause-related quality of life, assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b (PROMIS SD SF 8b) and Menopause-Specific Quality of Life (MENQOL) questionnaires.
TAKEAWAY:
- Elinzanetant significantly reduced the frequency of vasomotor symptoms by week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1]; OASIS 2: −3.0 [95% CI, −4.4 to −1.7]; P < .001).
- By week 12, elinzanetant further reduced vasomotor symptom frequency (OASIS 1: −3.2 [95% CI, −4.8 to −1.6]; OASIS 2: −3.2 [95% CI, −4.6 to −1.9]; P < .001).
- Elinzanetant improved sleep disturbances, with significant reductions in PROMIS SD-SF 8b total T scores at week 12 (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 improved significantly with elinzanetant, as indicated by reductions in MENQOL total scores at week 12 (OASIS 1: −0.4 [95% CI, −0.6 to −0.2]; OASIS 2: − 0.3 [95% CI, −0.5 to − 0.1]; P = .0059).
IN PRACTICE:
“These results have clinically relevant implications because vasomotor symptoms often pose significant impacts on menopausal individual’s overall health, everyday activities, sleep, quality of life, and work productivity,” wrote the study authors.
SOURCE:
The studies were led by JoAnn V. Pinkerton, MD, MSCP, University of Virginia Health in Charlottesville, and James A. Simon, MD, MSCP, George Washington University in Washington, DC. The results were published online in JAMA.
LIMITATIONS:
The OASIS 1 and 2 trials included only postmenopausal individuals, which may limit the generalizability of the findings to other populations. The study relied on patient-reported outcomes, which can be influenced by subjective perception and may introduce bias. The placebo response observed in the trials is consistent with that seen in other vasomotor symptom studies, potentially affecting the interpretation of the results. Further research is needed to assess the long-term safety and efficacy of elinzanetant beyond the 26-week treatment period.
DISCLOSURES:
Dr. Pinkerton received grants from Bayer Pharmaceuticals to the University of Virginia and consulting fees from Bayer Pharmaceutical. Dr. Simon reported grants from Bayer Healthcare, AbbVie, Daré Bioscience, Mylan, and Myovant/Sumitomo and personal fees from Astellas Pharma, Ascend Therapeutics, California Institute of Integral Studies, Femasys, Khyra, Madorra, Mayne Pharma, Pfizer, Pharmavite, Scynexis Inc, Vella Bioscience, and Bayer. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
. The drug also improved sleep disturbances and menopause-related quality of life, with a favorable safety profile.
METHODOLOGY:
- Researchers conducted two randomized, double-blind, placebo-controlled phase 3 trials (OASIS 1 and 2) across 77 sites in the United States, Europe, Canada, and Israel.
- A total of 796 postmenopausal participants aged 40-65 years experiencing moderate to severe vasomotor symptoms were included.
- Participants received either 120 mg of elinzanetant or a placebo once daily for 12 weeks, followed by elinzanetant for an additional 14 weeks.
- Primary outcomes measured were changes in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12, using an electronic hot flash daily diary.
- Secondary outcomes included changes in sleep disturbances and menopause-related quality of life, assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b (PROMIS SD SF 8b) and Menopause-Specific Quality of Life (MENQOL) questionnaires.
TAKEAWAY:
- Elinzanetant significantly reduced the frequency of vasomotor symptoms by week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1]; OASIS 2: −3.0 [95% CI, −4.4 to −1.7]; P < .001).
- By week 12, elinzanetant further reduced vasomotor symptom frequency (OASIS 1: −3.2 [95% CI, −4.8 to −1.6]; OASIS 2: −3.2 [95% CI, −4.6 to −1.9]; P < .001).
- Elinzanetant improved sleep disturbances, with significant reductions in PROMIS SD-SF 8b total T scores at week 12 (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 improved significantly with elinzanetant, as indicated by reductions in MENQOL total scores at week 12 (OASIS 1: −0.4 [95% CI, −0.6 to −0.2]; OASIS 2: − 0.3 [95% CI, −0.5 to − 0.1]; P = .0059).
IN PRACTICE:
“These results have clinically relevant implications because vasomotor symptoms often pose significant impacts on menopausal individual’s overall health, everyday activities, sleep, quality of life, and work productivity,” wrote the study authors.
SOURCE:
The studies were led by JoAnn V. Pinkerton, MD, MSCP, University of Virginia Health in Charlottesville, and James A. Simon, MD, MSCP, George Washington University in Washington, DC. The results were published online in JAMA.
LIMITATIONS:
The OASIS 1 and 2 trials included only postmenopausal individuals, which may limit the generalizability of the findings to other populations. The study relied on patient-reported outcomes, which can be influenced by subjective perception and may introduce bias. The placebo response observed in the trials is consistent with that seen in other vasomotor symptom studies, potentially affecting the interpretation of the results. Further research is needed to assess the long-term safety and efficacy of elinzanetant beyond the 26-week treatment period.
DISCLOSURES:
Dr. Pinkerton received grants from Bayer Pharmaceuticals to the University of Virginia and consulting fees from Bayer Pharmaceutical. Dr. Simon reported grants from Bayer Healthcare, AbbVie, Daré Bioscience, Mylan, and Myovant/Sumitomo and personal fees from Astellas Pharma, Ascend Therapeutics, California Institute of Integral Studies, Femasys, Khyra, Madorra, Mayne Pharma, Pfizer, Pharmavite, Scynexis Inc, Vella Bioscience, and Bayer. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
. The drug also improved sleep disturbances and menopause-related quality of life, with a favorable safety profile.
METHODOLOGY:
- Researchers conducted two randomized, double-blind, placebo-controlled phase 3 trials (OASIS 1 and 2) across 77 sites in the United States, Europe, Canada, and Israel.
- A total of 796 postmenopausal participants aged 40-65 years experiencing moderate to severe vasomotor symptoms were included.
- Participants received either 120 mg of elinzanetant or a placebo once daily for 12 weeks, followed by elinzanetant for an additional 14 weeks.
- Primary outcomes measured were changes in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12, using an electronic hot flash daily diary.
- Secondary outcomes included changes in sleep disturbances and menopause-related quality of life, assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b (PROMIS SD SF 8b) and Menopause-Specific Quality of Life (MENQOL) questionnaires.
TAKEAWAY:
- Elinzanetant significantly reduced the frequency of vasomotor symptoms by week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1]; OASIS 2: −3.0 [95% CI, −4.4 to −1.7]; P < .001).
- By week 12, elinzanetant further reduced vasomotor symptom frequency (OASIS 1: −3.2 [95% CI, −4.8 to −1.6]; OASIS 2: −3.2 [95% CI, −4.6 to −1.9]; P < .001).
- Elinzanetant improved sleep disturbances, with significant reductions in PROMIS SD-SF 8b total T scores at week 12 (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 improved significantly with elinzanetant, as indicated by reductions in MENQOL total scores at week 12 (OASIS 1: −0.4 [95% CI, −0.6 to −0.2]; OASIS 2: − 0.3 [95% CI, −0.5 to − 0.1]; P = .0059).
IN PRACTICE:
“These results have clinically relevant implications because vasomotor symptoms often pose significant impacts on menopausal individual’s overall health, everyday activities, sleep, quality of life, and work productivity,” wrote the study authors.
SOURCE:
The studies were led by JoAnn V. Pinkerton, MD, MSCP, University of Virginia Health in Charlottesville, and James A. Simon, MD, MSCP, George Washington University in Washington, DC. The results were published online in JAMA.
LIMITATIONS:
The OASIS 1 and 2 trials included only postmenopausal individuals, which may limit the generalizability of the findings to other populations. The study relied on patient-reported outcomes, which can be influenced by subjective perception and may introduce bias. The placebo response observed in the trials is consistent with that seen in other vasomotor symptom studies, potentially affecting the interpretation of the results. Further research is needed to assess the long-term safety and efficacy of elinzanetant beyond the 26-week treatment period.
DISCLOSURES:
Dr. Pinkerton received grants from Bayer Pharmaceuticals to the University of Virginia and consulting fees from Bayer Pharmaceutical. Dr. Simon reported grants from Bayer Healthcare, AbbVie, Daré Bioscience, Mylan, and Myovant/Sumitomo and personal fees from Astellas Pharma, Ascend Therapeutics, California Institute of Integral Studies, Femasys, Khyra, Madorra, Mayne Pharma, Pfizer, Pharmavite, Scynexis Inc, Vella Bioscience, and Bayer. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.