title: Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To assess fall events in older depressed patients during treatment with duloxetine.
  
  
  METHODS
  Post hoc analysis of solicited fall events collected at each study visit using a questionnaire during a 24-week, multicenter, randomized, placebo-controlled, double-blind, phase 4 trial (November 2006 to November 2009). Older outpatients (≥ 65 years) with major depressive disorder (DSM-IV criteria) were randomly assigned to duloxetine 60 mg/d (n = 249) or placebo (n = 121) for the 12-week acute phase, after which the duloxetine dose could be increased to 120 mg/d and nonresponding placebo patients could be switched to duloxetine 60 mg/d. Between-treatment differences in percentages of patients with fall events were compared by Fisher exact test. Exposure-adjusted incidence rates (EAIRs) of falls per patient-year were also estimated.
  
  
  RESULTS
  In the acute phase, 17.3% of patients treated with duloxetine 60 mg versus 11.6% treated with placebo (P = .170) experienced a fall event. Over 24 weeks, the percentage of patients with a fall while taking duloxetine 60 mg versus placebo was 24.0% versus 15.7% (P = .078), and the percentage was significantly higher in patients taking duloxetine regardless of dose (25.3%) than with placebo (15.7%, P = .045). Between-treatment differences in EAIRs over 12 weeks (0.26; 95% CI, -0.20 to 0.72) and over 24 weeks (0.27; 95% CI, -0.10 to 0.65) were not significant.
  
  
  CONCLUSIONS
  Direct assessment of fall events greatly increases the number of falls reported by patients. Although the EAIR of falls per patient-year associated with duloxetine was not significant in this trial, clinicians should remain vigilant about the possibility of falls in older patients with duloxetine or any antidepressant treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00406848.
authors.affiliation: Department of Psychiatry, University of California, San Francisco, California, USA.
authors.forename: J Craig
authors.initials: JC
authors.lastname: Nelson
authors.forename: Tina M M
authors.initials: TM
authors.lastname: Oakes
authors.forename: Peng
authors.initials: P
authors.lastname: Liu
authors.forename: Jonna
authors.initials: J
authors.lastname: Ahl
authors.forename: Mark E
authors.initials: ME
authors.lastname: Bangs
authors.forename: Joel
authors.initials: J
authors.lastname: Raskin
authors.forename: David G
authors.initials: DG
authors.lastname: Perahia
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Robinson