A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age
Abstract Introduction Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported dur...
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BMC
2024-11-01
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| Series: | Annals of General Psychiatry |
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| Online Access: | https://doi.org/10.1186/s12991-024-00519-9 |
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| author | Andrea Fagiolini Melissa Paulita Mariano Egbert Biesheuvel Pradeep Purushottamahanti |
| author_facet | Andrea Fagiolini Melissa Paulita Mariano Egbert Biesheuvel Pradeep Purushottamahanti |
| author_sort | Andrea Fagiolini |
| collection | DOAJ |
| description | Abstract Introduction Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported during their reproductive years. This post-hoc pooled analysis evaluated the efficacy of sertraline (one of the most studied medications in women) in women of reproductive age (18–44 years). Methods Data was pooled from nine clinical trials of sertraline that included 1832 subjects with MDD. The analysis set included 1097 women, 651 of those were of reproductive age. Sertraline was compared with placebo for changes in total HAM-D17 and CGI scores measured over time through MMRM analysis. The change from baseline to the end of study (-week 8) was assessed using ANCOVA. Results The changes from baseline in total HAM-D17 and CGI scores were significantly higher for sertraline than for placebo at the end of 8 weeks for all women (LS Mean difference, 95% CI: -1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P < 0.0001, respectively). For women of reproductive age these changes (LS Mean difference, 95% CI: -2.08(-3.52,-0.64), P = 0.0047; -0.44(-0.66,-0.22), P < 0.0001, respectively), were significant from week 2 (HAM-D17) and week 1 (CGI) till the end of study. Limitations Only sertraline and placebo arms were included in the analysis. The dosing varied between studies, and the effect of dose was not addressed. Conclusions Sertraline is an effective option for treatment of MDD in women, including those in the childbearing age. |
| format | Article |
| id | doaj-art-5a01ef6543fd431c8e11ee0e3e62ff3a |
| institution | Kabale University |
| issn | 1744-859X |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Annals of General Psychiatry |
| spelling | doaj-art-5a01ef6543fd431c8e11ee0e3e62ff3a2024-11-10T12:36:17ZengBMCAnnals of General Psychiatry1744-859X2024-11-0123111010.1186/s12991-024-00519-9A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing ageAndrea Fagiolini0Melissa Paulita Mariano1Egbert Biesheuvel2Pradeep Purushottamahanti3Department of Molecular Medicine, University of Siena School of MedicineDepartment of Psychiatry, University of the East Ramon Magsaysay Memorial Medical CentreBiometrics, Viatris IncGlobal Medical Affairs, Viatris IncAbstract Introduction Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported during their reproductive years. This post-hoc pooled analysis evaluated the efficacy of sertraline (one of the most studied medications in women) in women of reproductive age (18–44 years). Methods Data was pooled from nine clinical trials of sertraline that included 1832 subjects with MDD. The analysis set included 1097 women, 651 of those were of reproductive age. Sertraline was compared with placebo for changes in total HAM-D17 and CGI scores measured over time through MMRM analysis. The change from baseline to the end of study (-week 8) was assessed using ANCOVA. Results The changes from baseline in total HAM-D17 and CGI scores were significantly higher for sertraline than for placebo at the end of 8 weeks for all women (LS Mean difference, 95% CI: -1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P < 0.0001, respectively). For women of reproductive age these changes (LS Mean difference, 95% CI: -2.08(-3.52,-0.64), P = 0.0047; -0.44(-0.66,-0.22), P < 0.0001, respectively), were significant from week 2 (HAM-D17) and week 1 (CGI) till the end of study. Limitations Only sertraline and placebo arms were included in the analysis. The dosing varied between studies, and the effect of dose was not addressed. Conclusions Sertraline is an effective option for treatment of MDD in women, including those in the childbearing age.https://doi.org/10.1186/s12991-024-00519-9Major depressive disorderClinical studiesSertralinePost-hoc analysisEfficacyFocus on women and women of childbearing age |
| spellingShingle | Andrea Fagiolini Melissa Paulita Mariano Egbert Biesheuvel Pradeep Purushottamahanti A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age Annals of General Psychiatry Major depressive disorder Clinical studies Sertraline Post-hoc analysis Efficacy Focus on women and women of childbearing age |
| title | A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age |
| title_full | A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age |
| title_fullStr | A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age |
| title_full_unstemmed | A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age |
| title_short | A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age |
| title_sort | pooled analysis of the efficacy of sertraline in women with a focus on those of childbearing age |
| topic | Major depressive disorder Clinical studies Sertraline Post-hoc analysis Efficacy Focus on women and women of childbearing age |
| url | https://doi.org/10.1186/s12991-024-00519-9 |
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