The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity

Thomas Wise, C. G. Wiltse, D. V. Iosifescu, M. Sheridan, J. Y. Xu, J. Raskin

Research output: Contribution to journalArticle

Abstract

Aim and methods: The impact of medical comorbidity on the efficacy and tolerability of duloxetine in elderly patients with major depressive disorder (MDD) was investigated in this study. Data were obtained from a multicentre, randomised, double-blind, placebo-controlled study in 311 patients with MDD aged 65-89. The primary outcome measure was a prespecified composite cognitive score based on four cognitive tests: (i) Verbal Learning and Recall Test; (ii) Symbol Digit Substitution Test; (iii) 2-Digit Cancellation Test and (iv) Letter-Number Sequencing Test. Secondary measures included the Geriatric Depression Scale (GDS), 17-Item Hamilton Depression Scale (HAMD17), Clinical Global Impression-Severity (CGI-S) Scale, Visual Analogue Scale (VAS) for pain and 36-Item Short Form Health Survey (SF-36). Tolerability measures included adverse events reported as the reason for discontinuation and treatment-emergent adverse events (TEAEs). The consistency of the effect of duloxetine vs. placebo comparing patients with and without medical comorbidity (vascular disease, diabetes, arthritis or any of these) was investigated. Results: Overall, duloxetine 60 mg/day demonstrated significantly greater improvement compared with placebo for the composite cognitive score, GDS and HAMD17 total scores, CGI-Severity, HAMD17 response and remission rates, and some of the SF-36 and VAS measures. There were few significant treatment-by- comorbidity subgroup interactions for these efficacy variables, or for adverse events reported as the reason for discontinuation and common TEAEs. Conclusions: The present analyses suggested that the efficacy of duloxetine on cognition and depression in elderly patients, and its tolerability, were not largely affected by the comorbidity status. These results further support the use of duloxetine in elderly patients with MDD.

Original languageEnglish (US)
Pages (from-to)1283-1293
Number of pages11
JournalInternational Journal of Clinical Practice
Volume61
Issue number8
DOIs
StatePublished - Aug 1 2007
Externally publishedYes

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Comorbidity
Major Depressive Disorder
Safety
Depression
Placebos
Geriatrics
Verbal Learning
Pain Measurement
Health Surveys
Visual Analog Scale
Vascular Diseases
Cognition
Arthritis
Therapeutics
Outcome Assessment (Health Care)
Duloxetine Hydrochloride

ASJC Scopus subject areas

  • Medicine(all)

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The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. / Wise, Thomas; Wiltse, C. G.; Iosifescu, D. V.; Sheridan, M.; Xu, J. Y.; Raskin, J.

In: International Journal of Clinical Practice, Vol. 61, No. 8, 01.08.2007, p. 1283-1293.

Research output: Contribution to journalArticle

Wise, Thomas ; Wiltse, C. G. ; Iosifescu, D. V. ; Sheridan, M. ; Xu, J. Y. ; Raskin, J. / The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. In: International Journal of Clinical Practice. 2007 ; Vol. 61, No. 8. pp. 1283-1293.
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