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Randomized Controlled Trial
. 2007 Aug;61(8):1283-93.
doi: 10.1111/j.1742-1241.2007.01476.x. Epub 2007 Jun 22.

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

T N Wise  1 , C G Wiltse, D V Iosifescu, M Sheridan, J Y Xu, J Raskin
Affiliations
Randomized Controlled Trial

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

T N Wise et al. Int J Clin Pract. 2007 Aug.

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.

Trial registration: ClinicalTrials.gov NCT00062673.

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Figures

Figure 1
Figure 1
Effects of duloxetine compared with placebo on composite cognitive score: mean change analysis in all randomised patients and in baseline comorbidity subgroups
Figure 2
Figure 2
(A) Effects of duloxetine compared with placebo on GDS total score: mean change analysis in all randomised patients and in baseline comorbidity subgroups. (B) Effects of duloxetine compared with placebo on HAMD17 total score: mean change analysis in all randomised patients and in baseline comorbidity subgroups
Figure 3
Figure 3
Effects of duloxetine compared with placebo on SF-36 Physical Component Summary: mean change analysis in all randomised patients and in baseline comorbidity subgroups
See this image and copyright information in PMC

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