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SADHART-CHF: Sertraline safe but provided no benefits for patients with HF, depression vs. placebo
Goodlin S. J Am Coll Cardiol. 2010;56:700-701.
O’Connor C. J Am Coll Cardiol. 2010;56:692-699.
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Sertraline vs. placebo was safe in patients with HF and depression, but did not provide greater reduction in depression or improved CV status, study results suggested.
The Sertraline Against Depression and Heart Disease in Chronic Heart Failure (SADHART-CHF) trial was a randomized, double blind, placebo-controlled trial, which compared 50 to 200 mg/day of sertraline vs. matching placebo for 12 weeks. Patients (n=469) were at least 45 years of age and had HF (left ventricular ejection fraction ≤45%, NYHA Class II-IV) and clinical depression (DSM-IV criteria for current major depressive disorder). Primary endpoints were change at 12 weeks in depression severity determined by the Hamilton Depression Rating Scale total score and composite CV status.
According to study results, the mean ± SE change from baseline to 12 weeks for the sertraline patients (n=234) was–7.1 ± 0.5, and for those in the placebo arm (n=235), it was –6.8 ± 0.5 (mean change between groups, 0.4; 95% CI,–1.7 to 0.92). Additional statistics in the sertraline group indicated that the percentage of patients with a composite CV score that worsened was 29.9%, improved was 40.6% and unchanged was 29.5%; in the placebo group, the percentages were 31.1% for those with worsened scores, 43.8% for those whose scores improved and 25.1% for those whose scores did not change.
“Sertraline did not adversely affect CV outcomes in this population, and it may be an appropriate therapeutic strategy in patients who remain depressed despite nonpharmacologic interventions and who otherwise have an indication for sertraline,” researchers concluded.
In an accompanying editorial, Sarah J. Goodlin, MD, with Patient-Centered Education and Research, Salt Lake City, summarized the key findings from the trial.
“The SADHART-CHF trial tells us that discontinuation or adverse event rates were a bit higher with low-dose sertraline than with placebo, that low to moderate doses of sertraline are not associated with increased HF decompensation or death, and that supportive nursing interventions seem as effective as low-dose sertraline for HF patients with moderate depressive symptoms,” she said. “Further research is needed to tell us whether higher doses of sertraline or other antidepressants are both safe and effective.”
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