September 23, 2008 – Results of the SADHART (Safety and Efficacy of Sertraline for Depression in Patients with CHF) clinical trial were presented yesterday at the 12th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Toronto, presenting evidence of how treatment can improve depression and morbidity in heart failure.
Christopher O'Connor, M.D., (professor of medicine and director, Duke Heart Center, Duke University) highlighted the results of treating patients who suffer from heart failure and depression with the drug Sertraline, which is a selective serotonin-reuptake inhibitor (SSRI) anti-depressant with psycho-supportive therapy. It was used to evaluate the effectiveness in improving mood disorders, and the results also showed a decrease in mortality with heart failure patients.
"For years, the only anti-depressive treatments were in the form of tricyclics, which were associated with instances of sudden death and arrhythmias in patients being treated for both chronic heart failure and mood disorders," said Barry Greenberg, M.D., HFSA president, and professor of medicine, and director, Advanced Heart Failure Treatment Program, University of California, San Diego. "Finding a safe and effective means to treat depression and lower the fatality rates in heart failure patients would mark a major advancement for the medical community, and bring relief and a renewed hope for cardiology patients."
Dr. O'Connor explained that the trial was designed to test the hypothesis that heart failure patients treated with Sertraline plus psycho-supportive therapy will have an improvement in symptoms of depression and a lower rate of mortality and cardiovascular events as compared to psycho-supportive therapy alone. This larger trial was in response to a similar trial, which had showed promising results that Sertraline not only proved to be safe and effective, but tended to reduce morbidity and mortality and improve depression in heart failure patients. This larger trial SADHART was a randomized, double-blind, placebo-controlled study that investigated the use of Sertraline as an effective way to treat patients who presented as having a major depressive disorder (MDD) and a diagnosis of heart failure. The trial, sponsored by the National Institute of Mental Health, studied a population of 500 men and women 45 years of age or older who were randomized to Sertraline or placebo group for a 12-week acute treatment phase. All patients were followed for six months. Quality of life and physiologic parameters, as well as pro-inflammatory and HF biomarkers were also obtained.
"Sertraline has a very favorable pharmacological profile, in terms of adverse reactions with other drugs, which is crucial because heart failure patients often take up to 12 different medications. Our study aims to test whether depression, which has been an ongoing topic of research since the 1920s, can be greatly reduced through the use of SSRI's like Sertraline or by psycho-supportive therapy," said Dr. O'Connor, who added that patients with heart failure and depression are twice as likely to die from cardiac complications than patients who suffer from heart failure. "We hope that this presentation demonstrates the importance of identifying and treating depression in heart failure patients must continually be examined. We hope to soon conduct similar trials to SADHART, but with a long-term period of follow-up in similar study populations."
For more information: www.hfsa.org/, www.abouthf.org/