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Lessons From SADHART, ENRICHD, and Other Trials

From the Department of Medicine, Duke University Medical Center, Durham, North Carolina.

Address correspondence and reprint requests to Karen E. Joynt, MD, DUMC Box 31091, Durham, NC 27708. E-mail: joynt001{at}mc.duke.edu

Depression is highly prevalent in patients with cardiovascular disease and is independently associated with a poor prognosis when present. A very important aspect of continued therapeutic advances in this field will be the ability to show a convincing connection between the treatment of depression in patients with heart disease and a reduction in morbidity and mortality associated with the co-occurrence of these conditions. The recent SADHART (Sertraline AntiDepressant Heart Attack Trial) investigation demonstrated that sertraline is safe and efficacious in depressed patients with ischemic heart disease but was underpowered to detect a mortality difference between sertraline and placebo. The ENRICHD (ENhancing Recovery in Coronary Heart Disease) trial showed that cognitive-behavioral therapy is effective for treating depression but had no impact on cardiovascular morbidity or mortality. There are a number of methodologic complexities associated with research regarding depression and cardiovascular disease, including difficulties in the definition and measurement of depression, complexities in the conduction of large-scale trials, ethical considerations surrounding the use of placebo, and interpretation of trial results. In addition, the lack of certainty regarding the pathophysiologic link between depression and cardiovascular disease means that there is a lack of pharmacotherapy targeted specifically at the dysregulated physiology that might explain the increased morbidity and mortality seen when these two conditions occur together.

Key Words: cardiovascular disease • myocardial infarction • major depressive disorder • antidepressant • research methodology • placebo effect

Abbreviations: BDI = Beck Depression Inventory; CAD = coronary artery disease; CBT = cognitive behavioral therapy; CGI-I = Clinical Global Impression Improvement; CVD = cardiovascular disease; ECG = electrocardiogram; ENRICHD = Enhancing Recovery in Coronary Heart Disease; HAM-D = Hamilton Depression; HR = hazard ratio; HRV = heart rate variability; HRSD = Hamilton Rating Scale for Depression; MI = myocardial infarction; MIND-IT = Myocardial Infarction and Depression Intervention Trial; NHLBI = National Heart Lung and Blood Institute; SADHART = Sertraline Anti-Depressant Heart Attack Randomized Trial; SSRI = selective serotonin reuptake inhibitor.

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