Effect of escitalopram on all-cause mortality and hospitalization in patients with heart failure and depression: the MOOD-HF randomized clinical trial
<h3>Importance</h3><p>Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown.</p><h3>Objective</h3><p>To d...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
June 28, 2016
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| In: |
The journal of the American Medical Association
Year: 2016, Jahrgang: 315, Heft: 24, Pages: 2683-2693 |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2016.7635 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1001/jama.2016.7635 Verlag, lizenzpflichtig, Volltext: https://jamanetwork.com/journals/jama/fullarticle/2530538 
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| Verfasserangaben: | Christiane E. Angermann, MD; Götz Gelbrich, PhD; Stefan Störk, MD, PhD; Hilka Gunold, MD; Frank Edelmann, MD; RolfWachter, MD; Heribert Schunkert, MD; Tobias Graf, MD; Ingrid Kindermann, MD; Markus Haass, MD; Stephan Blankenberg, MD; Sabine Pankuweit, MD; Christiane Prettin, PhD; Martin Gottwik, MD; Michael Böhm, MD; Hermann Faller,MD, PhD; Jürgen Deckert, MD; Georg Ertl, MD; for the MOOD-HF Study Investigators and Committee Members |
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| 245 | 1 | 0 | |a Effect of escitalopram on all-cause mortality and hospitalization in patients with heart failure and depression |b the MOOD-HF randomized clinical trial |c Christiane E. Angermann, MD; Götz Gelbrich, PhD; Stefan Störk, MD, PhD; Hilka Gunold, MD; Frank Edelmann, MD; RolfWachter, MD; Heribert Schunkert, MD; Tobias Graf, MD; Ingrid Kindermann, MD; Markus Haass, MD; Stephan Blankenberg, MD; Sabine Pankuweit, MD; Christiane Prettin, PhD; Martin Gottwik, MD; Michael Böhm, MD; Hermann Faller,MD, PhD; Jürgen Deckert, MD; Georg Ertl, MD; for the MOOD-HF Study Investigators and Committee Members |
| 264 | 1 | |c June 28, 2016 | |
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| 520 | |a <h3>Importance</h3><p>Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown.</p><h3>Objective</h3><p>To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression.</p><h3>Design, Setting, and Participants</h3><p>The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) study was a double-blind, placebo-controlled randomized clinical trial conducted at 16 tertiary medical centers in Germany. Between March 2009 and February 2014, patients at outpatient clinics with New York Heart Association class II-IV heart failure and reduced left ventricular ejection fraction (<45%) were screened for depression using the 9-item Patient Health Questionnaire. Patients with suspected depression were then invited to undergo a Structured Clinical Interview based on the<i>Diagnostic and Statistical Manual of Mental Disorders</i>(Fourth Edition) to establish the diagnosis.</p><h3>Interventions</h3><p>Patients were randomized 1:1 to receive escitalopram (10-20 mg) or matching placebo in addition to optimal heart failure therapy. Study duration was 24 months.</p><h3>Main Outcomes and Measures</h3><p>The composite primary outcome was time to all-cause death or hospitalization. Prespecified secondary outcomes included safety and depression severity at 12 weeks of treatment (including the titration period), which were determined using the 10-item Montgomery-Åsberg Depression Rating Scale (total possible score, 0 to 60; higher scores indicate more severe depression).</p><h3>Results</h3><p>A total of 372 patients (mean age, 62 years; 24% female) were randomized and had taken at least 1 dose of study medication when the data and safety monitoring committee recommended the trial be stopped early. During a median participation time of 18.4 months (n = 185) for the escitalopram group and 18.7 months (n = 187) for the placebo group, the primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99 [95% CI, 0.76 to 1.27];<i>P</i> = .92). The mean Montgomery-Åsberg Depression Rating Scale sum score changed from 20.2 at baseline to 11.2 at 12 weeks in the escitalopram group and from 21.4 to 12.5 in the placebo group (between-group difference, −0.9 [95% CI,−2.6 to 0.7];<i>P</i> = .26). Safety parameters were comparable between groups.</p><h3>Conclusions and Relevance</h3><p>In patients with chronic heart failure with reduced ejection fraction and depression, 18 months of treatment with escitalopram compared with placebo did not significantly reduce all-cause mortality or hospitalization, and there was no significant improvement in depression. These findings do not support the use of escitalopram in patients with chronic systolic heart failure and depression.</p><h3>Trial Registration</h3><p>isrctn.com Identifier:ISRCTN33128015</p> | ||
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| 700 | 1 | |a Störk, Stefan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gunold, Hilka |e VerfasserIn |4 aut | |
| 700 | 1 | |a Edelmann, Frank |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wachter, Rolf |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schunkert, Heribert |e VerfasserIn |4 aut | |
| 700 | 1 | |a Graf, Tobias |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kindermann, Ingrid |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Blankenberg, Stephan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Pankuweit, Sabine |e VerfasserIn |4 aut | |
| 700 | 1 | |a Prettin, Christiane |e VerfasserIn |4 aut | |
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