6/29/23, 11:41 PM SADHART Pathway Feedback Search Clinical Topics Home Studies SADHART SADHART Disease Disease Disease Major depressive disorder Non-ST-elevation myocardial inf ST-elevat Trial question What is the role of sertraline treatment in patients with acute myocardial infarction or unstable angina? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 369 64.0% male 369 patients (133 female, 236 male) Inclusion criteria: patients with acute myocardial infarction 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) https://web.pathway.md/studies/rec5znFJkMGBI5yjm 1/2 6/29/23, 11:41 PM SADHART Pathway Primary outcome Left ventricular ejection fraction at week 16 13.0 % 13 11 9.8 % 6.5 % 3.3 % No significant difference 0.0 % Sertraline Placebo No significant difference in LVEF at week 16 (11% vs. 13%; RR 0.85, 95% CI 0 to 1.7) Secondary outcomes 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 myocardial infarction 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. Open reference URL https://web.pathway.md/studies/rec5znFJkMGBI5yjm 2/2