Sertraline Safe, Effective in Patients With Recent MI, Angina

Laurie Barclay, MD

August 13, 2002

Aug. 14, 2002 — Sertraline was safe and effective for treating major depression in patients with recent myocardial infarction (MI) or unstable angina, according to results of a randomized, double-blind trial published in the August 14 issue of The Journal of the American Medical Association.

"More than a million individuals in the U.S. experience acute coronary syndrome (ACS) each year and approximately 20% percent of these persons will also experience major depression, which imparts a three-fold increase in the risk of morbidity and mortality," write Alexander H. Glassman, MD, of the New York State Psychiatric Institute, and colleagues. "Even a modest reduction in risk, given the prevalence of these two conditions, would have significant public health consequences."

This trial, conducted in 40 outpatient cardiology centers and psychiatry clinics in the U.S., Europe, Canada, and Australia, enrolled 369 patients with major depressive disorder. Average age was 57.1 years, 64% were male, 74% had a recent MI, and 26% had unstable angina. Enrollment began in April 1997, and follow-up ended in April 2001. After a two-week, single-blind placebo period, patients were randomized to 24 weeks of treatment with sertraline in flexible dosages of 50 to 200 mg per day or placebo.

"We found no evidence of harm: sertraline was indistinguishable from placebo across all surrogate measures of cardiovascular safety," the authors write. Sertraline treatment was not associated with any change in left ventricular ejection fraction, blood pressure, heart rate, or runs of ventricular premature complex. The trend was for fewer severe cardiac events in patients receiving sertraline than in those receiving placebo (14.5% vs. 22.4%), although this difference was not statistically significant. In patient subgroups with at least one prior episode of depression, and in those with more severe major depressive disorder, antidepressant response as reflected in Hamilton Depression and Clinical Global Impression of Improvement scores was significantly better in patients receiving sertraline than in those receiving placebo.

"Depression that recurs or persists in ACS should be identified and treated because it is a serious illness that is both painful to patients and impedes their medical care," the authors write.

Pfizer, Inc. helped support this study and has financial arrangements with two of its authors.

In an accompanying editorial, Robert M. Carney, PhD, of Washington University School of Medicine in St. Louis, Missouri, and Allan S. Jaffe, MD, of Mayo Clinic in Rochester, Minnesota, describe this study as "not without flaws," but "truly an important trial...a major step forward in the care of depressed patients with coronary heart disease."

They recommend that future trials of antidepressant treatment after ACS enroll only patients who have depression that is unlikely to remit without treatment. At present, it is still unknown whether the risk of cardiac mortality and morbidity can be reduced by treating depression, but treating depression improves both quality of life and overall functioning.

"There is now an alternative to ignoring a comorbid psychiatric disorder that often has devastating consequences for these patients," they write. "We hope that the results of this important study will encourage physicians to recognize and appropriately treat depression in patients with heart disease."

JAMA. 2002;288(6):701-709, 750-751

Reviewed by Gary D. Vogin, MD

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