Cardiovascular safety of one-year escitalopram therapy in clinically nondepressed patients with acute coronary syndrome: results from the DEpression in patients with Coronary ARtery Disease (DECARD) trial.

BACKGROUND:Selective serotonin reuptake inhibitors are commonly used for treatment of depression in patients with cardiac diseases. However, evidence of cardiovascular (CV) safety from randomized trials is based on studies of no longer than 6-month duration. We examined the CV safety of 1-year treatment with Selective serotonin reuptake inhibitor escitalopram compared with placebo in patients with recent acute coronary syndrome (ACS). METHODS:The DECARD (DEpression in patients with Coronary ARtery Disease) trial assessed the prophylactic effect of escitalopram on depression after ACS. Two hundred forty patients were randomized to escitalopram 10-mg daily or matching placebo for 1 year. Serial measures of CV safety including clinical and biochemical parameters, 24-hour electrocardiogram monitor, resting electrocardiogram, and echocardiographic assessment were obtained. RESULTS:Escitalopram and placebo groups were comparable at baseline with regard to age, gender, sociodemography, depression score, risk factor profile, severity of heart disease, and medications. Dropout rates defined as withdrawal for any reason or lost to follow-up during the 12-month study period was 27.2% in the escitalopram group and 23.4% in the placebo group (NS). There were no statistically significant differences between intervention groups in any of CV safety measures including the incidence of ventricular arrhythmia and episodes of ST-segment depression, length of QTc, and systolic and diastolic echocardiographic measures at the 12-month follow-up between groups. After 12 months, 16 and 13 major adverse events (death, recurrent ACS, or acute revascularization) were recorded in the escitalopram and placebo group, respectively (NS). CONCLUSIONS:One-year escitalopram treatment was safe and well tolerated in patients with recent ACS.