Selective serotonin reuptake inhibitors were not associated with a significant difference in serious cardiovascular adverse events compared with placebo (OR 0.69; 95% CI 0.39-1.21).
Systematic Review
Do SSRIs increase or decrease the risk of cardiovascular adverse events in high-risk patients compared to placebo or TCAs?
This systematic review found no clear evidence that SSRIs increase or decrease cardiovascular adverse events compared to placebo in high-risk patients, though they may have fewer nonserious events than TCAs, highlighting the need for better adverse event reporting in trials.
Odds Ratio: 0.69 (95% CI 0.39–1.21)
OBJECTIVE: To examine whether selective serotonin reuptake inhibitor (SSRI) antidepressants were associated with an increased or decreased risk of cardiovascular adverse events (AEs). METHODS: We conducted a systematic review of randomized controlled trials published between 1967 and May 2005 that treated patients with cardiac disease, diabetes mellitus, stroke, geriatric age, nicotine dependence, alcoholism, HIV infection, and obesity. We defined serious AEs as death due to a cardiovascular cause, heart failure, stroke, transient ischemic attack, and myocardial infarction. Nonserious AEs were defined as palpitations, chest pain, angina, arrhythmia, hypertension, hypotension-syncope, and unspecified cardiovascular or neurologic events. Adverse event rates were calculated in 4 groups: SSRIs, tricyclic antidepressants (TCAs), other active therapies, and placebo. RESULTS: Stroke and cardiac patients were the highest-risk groups for cardiovascular AEs. We were unable to detect differences in odds between SSRI and placebo for both serious (odds ratio OR 0.69; 95% confidence interval CI, 0.39 to 1.21) and nonserious (OR 1.18; 95% CI, 0.90 to 1.57) cardiovascular AEs. There was a significant decrease in the odds of nonserious cardiovascular AEs (OR 0.46; 95% CI, 0.24 to 0.86, P = 0.02) for patients receiving SSRIs, compared with TCAs. Over one-half of the selected trials did not report the presence or absence of cardiovascular events. CONCLUSIONS: This systematic review of antidepressant trials in high-risk patients did not determine whether SSRIs are associated with a greater or lesser risk of cardiovascular AEs. Reasons for this conclusion include the rarity of serious AEs, the lack of large trials in these patients, and a lack of adequate reporting of AEs in published trials. Further trials assessing the risk of cardiovascular AEs and better trial reporting are needed.
Swenson et al. (2006) conducted a systematic review in High-risk patients (cardiac disease, diabetes, stroke, geriatric, etc.). Selective serotonin reuptake inhibitors (SSRIs) vs. Placebo was evaluated on Serious cardiovascular adverse events (death due to a cardiovascular cause, heart failure, stroke, transient ischemic attack, and myocardial infarction) (OR 0.69, 95% CI 0.39 to 1.21). Selective serotonin reuptake inhibitors were not associated with a significant difference in serious cardiovascular adverse events compared with placebo (OR 0.69; 95% CI 0.39-1.21).