Artur Menegaz de Almeida, Paloma Oliveira, Lucca Lopes, Marianna Leite, Victória Morbach, Francinny Alves Kelly, Ítalo Barros, Francisco Cezar Aquino de Moraes, Alexandra Prevedello
{"title":"非唑啉奈坦和依兰那坦治疗出现血管舒缩症状的绝经期妇女：系统回顾和荟萃分析。","authors":"Artur Menegaz de Almeida, Paloma Oliveira, Lucca Lopes, Marianna Leite, Victória Morbach, Francinny Alves Kelly, Ítalo Barros, Francisco Cezar Aquino de Moraes, Alexandra Prevedello","doi":"10.1097/AOG.0000000000005812","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To assess the efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in menopausal women.</p><p><strong>Data sources: </strong>MEDLINE, EMBASE, and Cochrane databases were systematically searched until August 22, 2024. Because the Cochrane Library included all the identified randomized controlled trials (RCTs), it was unnecessary to search ClinicalTrials.gov . The following words made up the search strategy, which was applied to the three databases: fezolinetant, elinzanetant, vasomotor symptoms, and menopause.</p><p><strong>Methods of study selection: </strong>Only RCTs comparing fezolinetant and elinzanetant with placebo for vasomotor symptoms in menopausal women were included.</p><p><strong>Tabulation, integration, and results: </strong>We extracted the number of patients, mean age, body mass index (BMI), and number of patients who underwent oophorectomy. Data were examined with the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed with I2 statistics. R 4.3.2 was used for statistical analysis. Seven RCTs with 4,087 patients were included in the analysis. Fezolinetant and elinzanetant were associated with diminished vasomotor symptom frequency: fezolinetant 30 mg (mean difference 2.16, 95% CI, 1.54-2.79, I2 =0%), fezolinetant 45 mg (mean difference 2.54, 95% CI, 1.86-3.21, I2 =0%), and elinzanetant 120 mg (mean difference 2.99, 95% CI, 1.74-4.23, I2 =0%). Both drugs also showed a decrease in vasomotor symptom severity: fezolinetant 30 mg (mean difference 0.20, 95% CI, 0.09-0.33, I2 =0%), fezolinetant 45 mg (mean difference 0.24, 95% CI, 0.13-0.34, I2 =0%), and elinzanetant 120 mg (mean difference 0.36, 95% CI, 0.26-0.46, I2 =0%). Elinzanetant 120 mg showed a significant improvement in sleep quality (mean difference 4.65, 95% CI, 3.73-5.56, I2 =0%). Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39-0.82, I2 =19%) and headache (2.54% vs 8.0%, RR 0.32, 95% CI, 0.16-0.64, I2 =0%).</p><p><strong>Conclusion: </strong>In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor symptoms. Elinzanetant provided a larger effect size in vasomotor symptom frequency and severity reduction and greatly improved sleep quality compared with fezolinetant.</p><p><strong>Systematic review registration: </strong>PROSPERO, CRD42023469952.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":" ","pages":"253-261"},"PeriodicalIF":5.7000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Fezolinetant and Elinzanetant Therapy for Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-analysis.\",\"authors\":\"Artur Menegaz de Almeida, Paloma Oliveira, Lucca Lopes, Marianna Leite, Victória Morbach, Francinny Alves Kelly, Ítalo Barros, Francisco Cezar Aquino de Moraes, Alexandra Prevedello\",\"doi\":\"10.1097/AOG.0000000000005812\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To assess the efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in menopausal women.</p><p><strong>Data sources: </strong>MEDLINE, EMBASE, and Cochrane databases were systematically searched until August 22, 2024. Because the Cochrane Library included all the identified randomized controlled trials (RCTs), it was unnecessary to search ClinicalTrials.gov . The following words made up the search strategy, which was applied to the three databases: fezolinetant, elinzanetant, vasomotor symptoms, and menopause.</p><p><strong>Methods of study selection: </strong>Only RCTs comparing fezolinetant and elinzanetant with placebo for vasomotor symptoms in menopausal women were included.</p><p><strong>Tabulation, integration, and results: </strong>We extracted the number of patients, mean age, body mass index (BMI), and number of patients who underwent oophorectomy. Data were examined with the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed with I2 statistics. R 4.3.2 was used for statistical analysis. Seven RCTs with 4,087 patients were included in the analysis. Fezolinetant and elinzanetant were associated with diminished vasomotor symptom frequency: fezolinetant 30 mg (mean difference 2.16, 95% CI, 1.54-2.79, I2 =0%), fezolinetant 45 mg (mean difference 2.54, 95% CI, 1.86-3.21, I2 =0%), and elinzanetant 120 mg (mean difference 2.99, 95% CI, 1.74-4.23, I2 =0%). Both drugs also showed a decrease in vasomotor symptom severity: fezolinetant 30 mg (mean difference 0.20, 95% CI, 0.09-0.33, I2 =0%), fezolinetant 45 mg (mean difference 0.24, 95% CI, 0.13-0.34, I2 =0%), and elinzanetant 120 mg (mean difference 0.36, 95% CI, 0.26-0.46, I2 =0%). Elinzanetant 120 mg showed a significant improvement in sleep quality (mean difference 4.65, 95% CI, 3.73-5.56, I2 =0%). Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39-0.82, I2 =19%) and headache (2.54% vs 8.0%, RR 0.32, 95% CI, 0.16-0.64, I2 =0%).</p><p><strong>Conclusion: </strong>In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor symptoms. 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Fezolinetant and Elinzanetant Therapy for Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-analysis.
Objective: To assess the efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in menopausal women.
Data sources: MEDLINE, EMBASE, and Cochrane databases were systematically searched until August 22, 2024. Because the Cochrane Library included all the identified randomized controlled trials (RCTs), it was unnecessary to search ClinicalTrials.gov . The following words made up the search strategy, which was applied to the three databases: fezolinetant, elinzanetant, vasomotor symptoms, and menopause.
Methods of study selection: Only RCTs comparing fezolinetant and elinzanetant with placebo for vasomotor symptoms in menopausal women were included.
Tabulation, integration, and results: We extracted the number of patients, mean age, body mass index (BMI), and number of patients who underwent oophorectomy. Data were examined with the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed with I2 statistics. R 4.3.2 was used for statistical analysis. Seven RCTs with 4,087 patients were included in the analysis. Fezolinetant and elinzanetant were associated with diminished vasomotor symptom frequency: fezolinetant 30 mg (mean difference 2.16, 95% CI, 1.54-2.79, I2 =0%), fezolinetant 45 mg (mean difference 2.54, 95% CI, 1.86-3.21, I2 =0%), and elinzanetant 120 mg (mean difference 2.99, 95% CI, 1.74-4.23, I2 =0%). Both drugs also showed a decrease in vasomotor symptom severity: fezolinetant 30 mg (mean difference 0.20, 95% CI, 0.09-0.33, I2 =0%), fezolinetant 45 mg (mean difference 0.24, 95% CI, 0.13-0.34, I2 =0%), and elinzanetant 120 mg (mean difference 0.36, 95% CI, 0.26-0.46, I2 =0%). Elinzanetant 120 mg showed a significant improvement in sleep quality (mean difference 4.65, 95% CI, 3.73-5.56, I2 =0%). Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39-0.82, I2 =19%) and headache (2.54% vs 8.0%, RR 0.32, 95% CI, 0.16-0.64, I2 =0%).
Conclusion: In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor symptoms. Elinzanetant provided a larger effect size in vasomotor symptom frequency and severity reduction and greatly improved sleep quality compared with fezolinetant.
期刊介绍：
"Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics.
"Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.
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