title: Treatment with duloxetine in adults and the incidence of cardiovascular events.
abstract: BACKGROUND
  Cardiovascular events are inconclusively associated with duloxetine use in clinical trials and spontaneous reports. This analysis of cardiovascular events in relation to duloxetine use within a large health insurance database provides further data on the association.
  
  
  METHODS
  This cohort study was conducted within a population with commercial health insurance. Adults with depression who initiated duloxetine were matched to separate cohorts of initiators of venlafaxine, selective serotonin reuptake inhibitors (SSRIs), and tricyclic antidepressants (TCAs), along with untreated patients with depression, and enrollees without depression. The cohorts were followed for cardiovascular events (acute myocardial infarction, sudden death, hypertensive crisis, arrhythmia, and coronary revascularization), which were identified through health insurance claims and confirmed upon review of underlying medical records. Proportional hazards and Poisson regression models were used for comparisons.
  
  
  RESULTS
  There were approximately 64,000 person-years of follow-up among all cohorts (including 17,386 person-years among 21,457 duloxetine initiators), yielding 279 cardiovascular events. Relative to duloxetine initiators, those without depression had lower rates of combined events (incidence rate ratio [IRR], 0.51; 95% confidence interval [CI], 0.32-0.81) and coronary revascularizations (IRR, 0.51; 95% CI 0.29-0.89). The IR of each of the cardiovascular outcomes did not differ across the other cohorts, even accounting for time since last duloxetine dispensing.
  
  
  CONCLUSIONS
  The incidence of cardiovascular events did not differ among duloxetine initiators relative to other antidepressant comparators or those with untreated depression but was higher than those without depression, suggesting that depression itself (or associated morbidities) may affect the risk of cardiovascular events.
authors.affiliation: Amgen, Thousand Oaks, CA, USA.
authors.forename: Fei
authors.initials: F
authors.lastname: Xue
authors.forename: Indiana
authors.initials: I
authors.lastname: Strombom
authors.forename: Bruce
authors.initials: B
authors.lastname: Turnbull
authors.forename: Shao
authors.initials: S
authors.lastname: Zhu
authors.forename: John
authors.initials: J
authors.lastname: Seeger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D016022:Case-Control Studies; D002423:Cause of Death; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use; D003866:Depressive Disorder / Q000188:drug therapy* / Q000401:mortality; D000068736:Duloxetine Hydrochloride; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007345:Insurance Claim Review; D008297:Male; D057216:Propensity Score; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013876:Thiophenes / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States; D000069470:Venlafaxine Hydrochloride; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D000929:Antidepressive Agents, Tricyclic; D003511:Cyclohexanols; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes; D000069470:Venlafaxine Hydrochloride