title: Safety and tolerability of duloxetine in elderly patients with major depressive disorder:  a pooled analysis of two placebo-controlled studies.
abstract: 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.
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA. oakes_tina_marie_myers@lilly.com
authors.forename: Tina M
authors.initials: TM
authors.lastname: Oakes
authors.forename: Cornelius
authors.initials: C
authors.lastname: Katona
authors.forename: Peng
authors.initials: P
authors.lastname: Liu
authors.forename: Michael
authors.initials: M
authors.lastname: Robinson
authors.forename: Joel
authors.initials: J
authors.lastname: Raskin
authors.forename: John H
authors.initials: JH
authors.lastname: Greist
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes