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In patients with cardiovascular diseases, depression is substantially more prevalent than in the general population. Epidemiological evidence has shown a robust relationship between depression and adverse outcomes in patients with heart failure (HF), including death, hospitalization, and worse health status. The benefits of pharmacotherapy for depression in HF patients are unproven, however. In the randomized, 12-week SADHART-CH trial, the selective serotonin reuptake inhibitor (SSRI) sertraline did not improve depression symptoms or clinical status in HF patients (NEJM JW Cardiol Nov 2010 and J Am Coll Cardiol 2010; 56:692). Now, researchers in the German, partially industry-supported, multisite MOOD-HF trial assessed longer-term effects of the SSRI escitalopram.
Of 2872 patients with confirmed symptomatic systolic HF, left ventricular ejection fraction <45%, and depressive symptoms, 372 patients (mean age, 62; 25% women) met DSM-IV criteria for major depression and were randomized to escitalopram (starting at 5 mg/day, titrated to ≤20 mg/day over 6 weeks as tolerated) or placebo.
All patients received increasing doses of HF therapies, as tolerated, and counseling and empowerment exercises. The Data Safety Monitoring Board terminated the study early for futility (median participation time, approximately 18.5 months).
The primary outcome, death or hospitalization, did not differ between the escitalopram and placebo groups (63% and 64%). At 12 weeks, health status and depression symptoms improved similarly in the two groups. Safety events did not differ between groups except for worsening depression, which occurred more commonly with placebo. Discontinuation of therapy at 12 weeks was significantly more frequent with escitalopram than with placebo (15% vs. 7%).
Angermann CE et al. Effect of escitalopram on all-cause mortality and hospitalization in patients with heart failure and depression: The MOOD-HF randomized clinical trial. JAMA 2016 Jun 28; 315:2683. (http://dx.doi.org/10.1001/jama.2016.7635)
Comment
As with SADHART-CH, MOOD-HF raises questions about the usefulness of SSRIs in depressed patients with HF, even for treating depressive symptoms. Although practitioners may continue to be tempted to use SSRIs, it is important to acknowledge that we're principally treating ourselves; the patient isn't likely to benefit.