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    EFFECTIVENESS AND SAFETY OF THE TETRAVALENT TAK-003 DENGUE VACCINE: A SYSTEMATIC REVIEW
    (2024)
    Ramos-rojas José
    ;
    Bengolea, Agustin
    ;
    Scigliano, Clara
    ;
    Rada, Gabriel  
    ;
    Catalano Hugo N.
      1
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    Efficacy and Tolerability of Combination Treatments for Major Depression: Antidepressants plus Second-Generation Antipsychotics vs. Esketamine vs. Lithium
    (2021)
    Gustavo H. Vázquez
    ;
    Anees Bahji
    ;
    UNDURRAGA FOURCADE, JUAN PABLO  
    ;
    Leonardo Tondo
    ;
    Ross J. Baldessarini
    <jats:sec><jats:title>Background:</jats:title><jats:p> Successful treatment of major depressive disorder (MDD) can be challenging, and failures ("treatment-resistant depression" [TRD]) are frequent. Steps to address TRD include increasing antidepressant dose, combining antidepressants, adding adjunctive agents, or using nonpharmacological treatments. Their relative efficacy and tolerability remain inadequately tested. In particular, the value and safety of increasingly employed second-generation antipsychotics (SGAs) and new esketamine, compared to lithium as antidepressant adjuncts remain unclear. </jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p> We reviewed randomized, placebo-controlled trials and used random-effects meta-analysis to compare odds ratio (OR) versus placebo, as well as numbers-needed-to-treat (NNT) and to-harm (NNH), for adding SGAs, esketamine, or lithium to antidepressants for major depressive episodes. </jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p> Analyses involved 49 drug-placebo pairs. By NNT, SGAs were more effective than placebo (NNT = 11 [CI: 9–15]); esketamine (7 [5–10]) and lithium (5 [4–10]) were even more effective. Individually, aripiprazole, olanzapine+fluoxetine, risperidone, and ziprasidone all were more effective (all NNT &lt; 10) than quetiapine (NNT = 13), brexpiprazole (16), or cariprazine (16), with overlapping NNT CIs. Risk of adverse effects, as NNH for most-frequently reported effects, among SGAs versus placebo was 5 [4–6] overall, and highest with quetiapine (NNH = 3), lowest with brexpiprazole (19), 5 (4–6) for esketamine, and 9 (5–106) with lithium. The risk/benefit ratio (NNH/NNT) was 1.80 (1.25–10.60) for lithium and much less favorable for esketamine (0.71 [0.60–0.80]) or SGAs (0.45 [0.17–0.77]). </jats:p></jats:sec><jats:sec><jats:title>Conclusions:</jats:title><jats:p> Several modern antipsychotics and esketamine appeared to be useful adjuncts to antidepressants for acute major depressive episodes, but lithium was somewhat more effective and better tolerated. </jats:p></jats:sec><jats:sec><jats:title>Limitations:</jats:title><jats:p> Most trials of adding lithium involved older, mainly tricyclic, antidepressants, and the dosing of adjunctive treatments were not optimized. </jats:p></jats:sec>
      30Scopus© Citations 66
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    Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants
    (2020)
    Eric A F Simões
    ;
    Eduardo Forleo-Neto
    ;
    Gregory P Geba
    ;
    Mohamed Kamal
    ;
    Feng Yang
    <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Respiratory syncytial virus (RSV) is a major cause of childhood medically attended respiratory infection (MARI).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>We conducted a randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2 doses of suptavumab, a human monoclonal antibody that can bind and block a conserved epitope on RSV A and B subtypes, for the prevention of RSV MARI. The primary endpoint was proportion of subjects with RSV-confirmed hospitalizations or outpatient lower respiratory tract infection (LRTI).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>There were no significant differences between primary endpoint rates (8.1%, placebo; 7.7%, 1-dose; 9.3%, 2-dose). Suptavumab prevented RSV A infections (relative risks, .38; 95% confidence interval [CI], .14–1.05 in the 1-dose group and .39 [95% CI, .14–1.07] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .0499), while increasing the rate of RSV B infections (relative risk 1.36 [95% CI, .73–2.56] in the 1-dose group and 1.69 [95% CI, .92–3.08] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .12). Sequenced RSV isolates demonstrated no suptavumab epitope changes in RSV A isolates, while all RSV B isolates had 2–amino acid substitution in the suptavumab epitope that led to loss of neutralization activity. Treatment emergent adverse events were balanced across treatment groups.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Suptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT02325791.</jats:p> </jats:sec>
    Scopus© Citations 72  1
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    Adapting to Adversity: Effects of COVID-19 on Parenting in Chile
    (2022)
    PÉREZ EWERT, JANET CAROLA  
    ;
    ALDONEY RAMIREZ, DANIELA  
    ;
    VIVANCO CARLEVARI, ANASTASSIA BELEN  
    ;
    COO CALCAGNI, SOLEDAD  
    ;
    Eugenio J. Guzmán
    <jats:p>The pandemic outbreak in March 2020 and its associated sanitary regulations and restrictions triggered an abrupt and significant change for society in general and for families’ organization in particular. In Chile, the Santiago Metropolitan District was under a strict lockdown that involved the closure of the entire educational system. From a systemic-family stress perspective, the impact of these changes might have consequences not only for each individual family member, but for the parental dynamic and, consequently, for children’s well-being. This paper presents the results of a follow-up study showing changes in self-reported parental depression and the perceived home organization of mothers and fathers assessed at three different moments: before the pandemic, at the initial outbreak, and after 1 month of strict lockdown. Relevant moderators were explored using linear mixed models to understand the within-subject changes in mothers’ and fathers’ self-reports across the different assessment times. Financial strain, personality traits of self-criticism and dependency, previous parent–child quality interaction, recent major stressful events, and number of children are highlighted as relevant factors that moderate changes in home chaos and parental mental health perception. Significant risks and protective factors are described for fathers and mothers. The use of pre-pandemic measures as baseline levels enabled the identification of personal and family characteristics that were related to better outcomes. The results help increase our understanding of the sanitary regulations’ impacts on the family system and identify vulnerability indicators that should be considered.</jats:p>
      1Scopus© Citations 4  1
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    Declining efficacy in controlled trials of antidepressants: effects of placebo dropout
    (2014)
    Stein Schalkwijk
    ;
    Juan Undurraga  
    ;
    Leonardo Tondo
    ;
    Ross J. Baldessarini
      20Scopus© Citations 32
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    Endoscopic full-thickness resection of esophagogastric junction gastrointestinal stromal tumor assisted by laparoscopy after neoadjuvant therapy
    (2016)
    ANDRÉS FRANCISCO NAVARRETE MOLINA
    ;
    Dulce Momblan
    ;
    Gloria Fernandez-Esparrach
    ;
    Salvadora Delgado
    ;
    Marta Jimenez
      5Scopus© Citations 2
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      9  1Scopus© Citations 3