SADHART
Trial question
What is the role of sertraline treatment in patients with acute MI or unstable angina?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 369
369 patients (133 female, 236 male).
Inclusion criteria: patients with acute MI or unstable angina and free of other life-threatening medical conditions who have major depressive disorder.
Key exclusion criteria: uncontrolled hypertension, MI or unstable angina of nonatherosclerotic etiology, alcohol or substance abuse or dependence in past 6 months, history of psychosis, bipolar disorder, organic brain syndrome, or dementia.
Interventions
N=186 sertraline (in flexible dosages of 50 to 200 mg/d for 24 weeks).
N=183 placebo (matching placebo for 24 weeks).
Primary outcome
Left ventricular ejection fraction at week 16
11%
13%
13.0 %
9.8 %
6.5 %
3.3 %
0.0 %
Sertraline
Placebo
No significant
difference ↔
No significant difference in LVEF at week 16 (11% vs. 13%; RR 0.85, 95% CI 0 to 1.7).
Secondary outcomes
Significant increase in CGI-I in group with at least 1 prior episode of depression (72% vs. 51%; RR 1.41, 95% CI 0.48 to 2.34).
No significant difference in death and urgent cardiovascular rehospitalizations (17.2% vs. 22.4%; RR 0.77, 95% CI 0.51 to 1.16).
No significant difference in the rate of death during the 24-week course (1.1% vs. 2.7%; RR 0.39, 95% CI 0.08 to 1.39).
Safety outcomes
No significant difference in treatment-emergent increase in ventricular premature complex runs or other cardiac measures.
Significant differences in nausea (19.9% vs. 10.9%), diarrhea (18.8% vs. 7.7%).
Conclusion
In patients with acute MI or unstable angina and free of other life-threatening medical conditions who have major depressive disorder, sertraline was not superior to placebo with respect to LVEF at week 16.
Reference
Glassman AH, O'Connor CM, Califf RM et al. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002 Aug 14;288(6):701-9.
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