Abstract
BackgroundLate-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who participated in a large, multinational, open-label study.MethodsPatients meeting DSM-IV criteria for MDD received duloxetine 80 mg/d (40 mg twice daily (BID)) to 120 mg/d (60 mg BID) for up to 52 weeks. Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, the 17-item Hamilton Rating Scale for Depression (HAMD17), the Beck Depression Inventory-II (BDI-II), the Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS). Safety and tolerability were evaluated using discontinuation rates, spontaneously reported adverse events, and changes in vital signs, ECG, and laboratory analytes.ResultsMean changes in HAMD17 total score at Weeks 6, 28, and 52 were -13.0, -17.4 and -17.5 (all p-values <.001). Significant improvement (p < .001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study. Observed case response rates at Weeks 6, 28, and 52 were 62.9%, 84.9%, and 89.4%, respectively, while the corresponding rates of remission were 41.4%, 69.8%, and 72.3%. Adverse events led to discontinuation in 27 (26.7%) patients. Treatment-emergent adverse events reported by >10% of patients included dizziness, nausea, constipation, somnolence, insomnia, dry mouth, and diarrhea. Most events occurred early in the study. Mean changes at endpoint in blood pressure and body weight were less than 2.0 mm Hg, and -0.1 kg, respectively.ConclusionsIn this open-label study, duloxetine was effective, safe, and well tolerated in the long-term treatment of MDD in patients aged 65 and older.
Highlights
Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy
Tricyclic antidepressants (TCAs) generally provide robust efficacy, but a number of side effects associated with this class of medications are of particular concern in older patients
Selective serotonin reuptake inhibitors (SSRIs) have provided an improved tolerability profile compared to the TCAs through lower rates of adverse events, and substantially lower toxicity in overdose [4]
Summary
Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who participated in a large, multinational, open-label study. Tricyclic antidepressants (TCAs) generally provide robust efficacy, but a number of side effects associated with this class of medications are of particular concern in older patients (e.g. anticholinergic adverse events, orthostatic hypotension, and sedation). SSRIs do not appear to exhibit agerelated increases in occurrence of adverse events [5]. These newer selective antidepressants appear, in general, to achieve equivalent or lower remission rates compared with the older tricyclics [6]
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