Probing the Safety of Medications in the Frail Elderly: Evidence From a Randomized Clinical Trial of Sertraline and Venlafaxine in Depressed Nursing Home Residents
J Clin Psychiatry 2003;64:875-882
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: In nursing home residents and other
frail elderly patients, old age and potential drug-drug and
drug-disease interactions may affect the relative safety and
efficacy of medications. The purpose of this study was to examine
the efficacy and tolerability of venlafaxine and sertraline for
the treatment of depression among nursing home residents.
Method: The study was a 10-week randomized,
double-blind, controlled trial of venlafaxine (doses up to 150
mg/day) versus sertraline (doses up to 100 mg/day) among 52
elderly nursing home residents with a DSM-IV depressive disorder
and, at most, moderate dementia. The primary measure of outcome
was the Hamilton Rating Scale for Depression (HAM-D). Adverse
events were monitored and recorded systematically during the
Results: Twelve subjects were discontinued due
to serious adverse events (SAE), 5 were discontinued due to other
significant side effects, and 2 withdrew consent. Tolerability
estimated by the time to termination was lower for venlafaxine
than sertraline for serious adverse events (log rank statistic =
5.28, p = .022), for serious adverse events or side effects (log
rank statistic = 8.08, p = .005), or for serious adverse events,
side effects, or withdrawal of consent (log rank statistic =
10.04, p = .002). Mean (SD) HAM-D scores at baseline were 20.2
(3.4) for sertraline and 20.3 (3.7) for venlafaxine;
intent-to-treat endpoint HAM-D scores were 12.2 (5.1) and 15.7
(6.2) (F = 3.45; p = .069). There were no differences in
categorical responses for the intent-to-treat sample or
Conclusion: In this frail elderly population,
venlafaxine was less well tolerated and, possibly, less safe than
sertraline without evidence for an increase in efficacy. This
unexpected finding demonstrates the need for systematic research
on the safety of drugs in the frail elderly.