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

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Abstract
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. 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. 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. Dr Wise and Dr Iosifescu have served in consultant/advisory roles for this clinical trial. Dr Iosifescu has received honoraria from Eli Lilly and Company. Neither author has received financial support from Eli Lilly and Company in the form of research funding in the past 2 years. Dr Sheridan has no financial relationship with Eli Lilly and Company. At the time this study was completed, Dr Raskin, Dr Wiltse and Dr Xu were employees of and owned stock in Eli Lilly and Company. What's known Analyses of primary efficacy data from this elderly study have shown that duloxetine 60 mg/day improved cognitive function. Duloxetine 60 mg/day also produced significant improvements vs. placebo in the Geriatric Depression Scale and HAMD17 total scores, as well as some pain measures. What's new The present report investigates the impact of medical comorbidity on the efficacy of duloxetine in the treatment of depression, improvement of cognition, as well as quality of life and its tolerability in elderly patients with major depressive disorder.