Sertraline treatment of major depression in patients with acute MI or unstable angina.
SADHART (Sertraline Antidepressant Heart Attack Randomized Trial) was a randomized controlled trial that compared sertraline with placebo in patients with major depressive disorder (MDD) who were hospitalized for acute myocardial infarction (MI) or unstable angina. The purpose of the study was to evaluate the safety and efficacy of sertraline to treat MDD after MI. Sertraline had no significant effects on cardiac measures when compared with placebo. Sertraline was associated with improvements in depression symptoms compared with placebo, especially among those with a history of depression.
- N=369 patients with MDD who had been hospitalized for MI or unstable angina (64% male, mean age 57) randomized to receive 24 weeks of:
- Sertraline (n=186)
- Placebo (n=183)
- Setting: 40 outpatient cardiology centers and psychiatry clinics in the United States, Europe, Canada, and Australia, 1997-2001.
- Primary outcome: Change from baseline left ventricular ejection fraction (LVEF) to assess safety.
- Secondary outcomes: surrogate cardiac measures and cardiovascular adverse events. For patients with prior history of MDD, or HAM-D score ≥18, also collected HAM-D and Clinical Global Impression Improvement scale (CGI-I).
- Primary outcome (LVEF) did not differ significantly between patients taking sertraline or placebo. This was even the case in the high-risk strata (baseline ejection fraction <30%).
- Secondary cardiac outcomes did not differ significantly between patients taking sertraline or placebo. These include heart rate, blood pressure, PR interval, QRS duration, QTc interval, and standard deviation of R-R intervals in a 24-hour period.
- Nausea and diarrhea were significantly more common in patients taking sertraline, when compared to placebo.
- In patients with HAM-D score ≥18 plus 2 previous depressive episodes, cardiovascular events were less frequent with sertraline (14.5%) than placebo (22.4%) but this did not reach statistical significance.
- Among all patients, sertraline was associated with significantly superior CGI-I score when compared with placebo (P=0.049), and there were significantly more CGI-I responders (CGI-I score ≤2) when compared with placebo (67% vs 53%, P=0.01). HAM-D score improvement did not reach statistical significance for all patients.
- For patients with a history of MDD, sertraline was associated with significant improvement in CGI-I score, HAM-D score, and number of CGI-I responders, when compared with placebo.
- For patients in the most severe group (2 prior episodes plus HAM-D ≥18), CGI-I response was seen in 78% of those taking sertraline, compared with 45% of those taking placebo (P=0.001).
Glassman AH, O’Connor CM, Califf RM, et al. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002;288(6):701-709.