PJ Online | News: Sertraline safe for depression post-MI
The Pharmaceutical Journal
Sertraline safe for depression post-MI
SERTRALINE (Lustral) is a safe and effective treatment for recurrent depression in patients with recent myocardial infarction (MI) or unstable angina, say American researchers.
Studies have shown that depression is an independent risk factor for cardiovascular mortality. However, Dr Alexander Glassman, of New York State Psychiatric Institute, and colleagues comment that most patients with a recent MI or unstable angina and co-morbid depression do not receive antidepressant treatment.
They randomly assigned 369 patients with major depressive disorder who had been admitted to hospital for acute MI or unstable angina to receive either sertraline or placebo for 24 weeks. Treatment was initiated as one tablet (50mg sertraline) per week but could be increased gradually to a maximum of four tablets after 12 weeks of treatment based on clinical response.
The researchers say that sertraline was indistinguishable from placebo across a range of measures of cardiovascular safety. They found that treatment was not associated with any change in left ventricular ejection volume, blood pressure, heart rate or arrhythmias and they saw no changes in electrocardiogram parameters.
"Furthermore, though not statistically significant, the incidence of severe cardiac events was numerically lower among patients receiving sertraline than among those receiving placebo," they say. They conclude that even a modest reduction in risk would have significant public health consequences.
The antidepressant effect of sertraline was measured as a secondary outcome in the study. Overall, sertraline was superior to placebo when symptoms of depression were assessed using the Clinical Global Impression, Improvement (CGI-I) scale. For two predefined subsets of patients ? those with at least one prior episode of depression and those with severe depression ? sertraline was shown to be better than placebo when symptoms were measured using both the CGI-I and Hamilton Depression scales (JAMA 2002;288:701).
In an accompanying editorial, Dr Robert Carney, Washington University School of Medicine, Missouri, and Dr Allan Jaffe, Mayo Clinic, Rochester, Minnesota, comment that the study "provides the first real evidence" that at least one of the selective serotonin reuptake inhibitor antidepressants is safe for use after an acute MI or an episode of unstable angina (ibid, p750).
"There is now an alternative to ignoring a co-morbid psychiatric disorder that often has devastating consequences for these patients." However, they point out that the results cannot be generalised to all post-MI patients and that the safety of sertraline in the early post-MI period is unclear. In addition, the study was too small to identify some drug-drug interactions or adverse events and, because sertraline was the only antidepressant tested in the trial, the results cannot be generalised to all SSRI antidepressants.
"Nevertheless, despite these qualifiers and caveats, clinicians now have a reason for cautious optimism when deciding whether it is safe to treat depression in patients with a recent MI or unstable angina," they say.
Citation: The Pharmaceutical Journal URI: 20007511
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