Safety and Tolerability of Duloxetine at 60 mg Once Daily in Elderly Patients With Major Depressive Disorder

Raskin, J. and Wiltse, C.G. and Dinkel, J.J. and Walker, D.J. and Desaiah, D. and Katona, Cornelius (2008) Safety and Tolerability of Duloxetine at 60 mg Once Daily in Elderly Patients With Major Depressive Disorder. Journal of Clinical Psychopharmacology, 28 (1). pp. 32-38. ISSN 0271-0749. (The full text of this publication is not available from this repository)

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Official URL
http://dx.doi.org/10.1097/jcp.0b013e318160738e

Abstract

Objective: To compare the safety and tolerability profile of duloxetine versus placebo in elderly (>=65 years) patients with major depressive disorder (MDD). Methods: Patients were randomized (2:1) to duloxetine 60 mg/d (once daily) (n = 207) or placebo (n = 104) for 8 weeks. Safety and tolerability measures were analyzed in the total cohort of patients, as well as in subgroups defined by age and preexisting hypertension. Results: Patients had a median age of 72 years (65-90 years). No deaths occurred in the study. Discontinuation rates due to adverse events were similar for duloxetine and placebo (9.7% vs 8.7%). Treatment-emergent dry mouth, nausea, and diarrhea occurred significantly (P <= 0.05) more frequently with duloxetine compared with placebo. Changes in supine and standing blood pressure (BP) and pulse and in corrected QT (QTc) interval were not significantly different between duloxetine and placebo, except for change in orthostatic systolic BP (-2.45 vs 0.93 mm Hg; P = .017). Incidences of sustained elevation in BP and treatment-emergent orthostatic hypotension were similar for duloxetine compared with placebo (0.5% vs 1.0% and 15.6% vs 20.5%, respectively). The duloxetine group showed significant weight loss compared with the placebo group (-0.73 kg vs -0.13 kg; P = 0.009). Of 5 hepatic analytes, the only significant difference was an increase in alkaline phosphatase in duloxetine compared with placebo (P = 0.017); this difference was not considered clinically relevant. The incidence of 1 or more discontinuation-emergent adverse events was not significantly different between the duloxetine and placebo groups (17.3% vs 11.3%). Conclusions: This study suggests that duloxetine is safe and well tolerated in elderly patients with major depressive disorder.

Item Type: Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculties > Science Technology and Medical Studies > Kent Institute of Medicine and Health Sciences (KIMHS)
Depositing User: M.P. Stone
Date Deposited: 27 Mar 2009 17:33
Last Modified: 27 May 2014 15:57
Resource URI: http://kar.kent.ac.uk/id/eprint/12253 (The current URI for this page, for reference purposes)
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