Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure

Abstract

Objective The objective was to test the hypothesis that heart failure (HF) patients treated with sertraline will have lower depression scores and fewer cardiovascular events compared to placebo. Background Depression is common among HF patients. It is associated with increased hospitalization and mortality. Methods SADHART-CHF was a randomized, double-blind, placebo-controlled trial of sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse facilitated support. Eligible patients were age ≥45 years with HF (LVEF ≤45%, NYHA class II-IV) and clinical depression (DSM-IV criteria for current major depressive disorder). Significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were exclusions. Primary endpoints were change in depression severity (Hamilton Depression Rating Scale [HDRS] total score) and composite cardiovascular status at12-weeks. Results 469 patients were randomized (N=234 sertraline, N=235 placebo). The mean ± SE change from baseline to 12-weeks in the HDRS total score was -7.1 ± 0.5 (sertraline) and -6.8 ± 0.5 (placebo) (P<.001 from baseline, P=.89 between groups, mean change between groups -0.4, 95% CI -1.7, 0.92). The proportion whose composite cardiovascular score worsened, improved, or was unchanged was 29.9%, 40.6%, and 29.5% in the sertraline group and 31.1%, 43.8%, and 25.1% in the placebo group (P=0.78). Discussion Sertraline was safe in patients with significant HF. However, treatment with sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression.

The Incidence, Clinical Significance, and Treatment Effects of Depression in Cardiac Resynchronization Therapy Recipients

“…Management of depression is difficult, complex, long-lasting, and burdened with a high rate of failure both in the general population and in CHF patients [18]. Because of the potential toxicity of tricyclic antidepressive drugs in CHF patients, therapeutic options for this population are limited mainly to selective serotonin reuptake inhibitors.…”

Depression and anxiety in cardiovascular disease

“…Most of the other studies did not find a significant influence of the use of SSRI on the overall mortality [14,[39][40][41][42][43][44], and some demonstrated that SSRIs significantly reduced the risk of death [45,46]. Diez-Quevedo et al [39] did not find an association between the use of antidepressants and increased mortality (HR = 0.89; 95% CI: 0.71-1.13).…”

“…O'Connor et al [40] showed that sertraline can be safely used in patients with advanced HF. However, the authors found that its use did not alleviate the severity of depression and did not improve the CVD in patients with HF and concomitant depression.…”

Psychological Aspects of Cardiac Care and Rehabilitation: Time to Wake Up to Sleep?

“…Although antidepressant medications (typically SSRIs), have been shown to improve depression in patients with CHD, particularly in patients with relapsing or severe depression [21], a stable finding across trials appears to be that there is little, if any, evidence that pharmacotherapy improves cardiac endpoints in depressed patients with CHD [99,21], and in patients with heart failure antidepressant medication has not been demonstrated to increase survival or significantly reduce depression [100].…”