Safety and tolerability of duloxetine in elderly patients with major depressive
disorder: a pooled analysis of two placebo-controlled studies.
Author(s): Oakes TM(1), Katona C, Liu P, Robinson M, Raskin J, Greist JH.
Affiliation(s): Author information:
(1)Eli Lilly and Company, Indianapolis, Indiana, USA.
oakes_tina_marie_myers@lilly.com
Publication date & source: 2013, Int Clin Psychopharmacol. , 28(1):1-11
The objective of this study was to examine the safety and tolerability of
duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, in a
large cohort of elderly patients with major depressive disorder. Data were pooled
from 8-week and 12-week, double-blind, randomized, placebo-controlled trials of
duloxetine 60 mg/day (duloxetine=456; placebo=225). Discontinuation rates because
of adverse events, treatment-emergent adverse events, abnormal changes in vital
signs and weight, and changes in laboratory analytes were compared between
treatments using a Cochran-Mantel-Haenszel test. Changes in laboratory analytes
were analyzed using an analysis of variance model. Adverse event-related
discontinuation rates were not significantly different between duloxetine and
placebo (10.7 vs. 7.1%; P=0.13). Treatment-emergent adverse events for duloxetine
of at least 5% and twice the rate of placebo were dry mouth, constipation,
nausea, diarrhea, dizziness, and fatigue. Abnormal changes in vital signs and
weight were not significantly different at any time between duloxetine and
placebo. The mean changes in platelet count, alkaline phosphatase, potassium,
random glucose, uric acid, and cholesterol were significantly different between
duloxetine and placebo (P<0.05), but none of these differences were considered
clinically relevant. The incidence of abnormal low sodium levels was not
significantly different between treatments. These safety results may better
inform clinicians providing individualized care to elderly patients with major
depressive disorder.
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