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Assessment of Falls in Older Patients Treated With Duloxetine: A Secondary Analysis of a 24-Week Randomized, Placebo-Controlled Trial

J. Craig Nelson, MD; Tina M. M. Oakes, PhD; Peng Liu, PhD; Jonna Ahl, PhD; Mark E. Bangs, MD; Joel Raskin, MD; David G. Perahia, MD; and Michael J. Robinson, MD

ABSTRACT

Objective: To assess fall events in older depressed patients during treatment with duloxetine.

Method: 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.

Trial Registration: ClinicalTrials.gov identifier NCT00406848

Prim Care Companion CNS Disord 2013;15(1):doi:10.4088/PCC.12m01419

Submitted: May 30, 2012; accepted September 17, 2012.

Published online: January 3, 2013.

Corresponding author: Tina M. M. Oakes, PhD, Eli Lilly and Company, Drop Code 1542, Indianapolis, IN 46285 (oakes_tina_marie_myers@lilly.com).