International clinical psychopharmacology
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Int Clin Psychopharmacol · Jan 2013
Meta AnalysisSafety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies.
The objective of this study was to examine the safety and tolerability of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, in a large cohort of elderly patients with major depressive disorder. Data were pooled from 8-week and 12-week, double-blind, randomized, placebo-controlled trials of duloxetine 60 mg/day (duloxetine=456; placebo=225). Discontinuation rates because of adverse events, treatment-emergent adverse events, abnormal changes in vital signs and weight, and changes in laboratory analytes were compared between treatments using a Cochran-Mantel-Haenszel test. ⋯ The mean changes in platelet count, alkaline phosphatase, potassium, random glucose, uric acid, and cholesterol were significantly different between duloxetine and placebo (P<0.05), but none of these differences were considered clinically relevant. The incidence of abnormal low sodium levels was not significantly different between treatments. These safety results may better inform clinicians providing individualized care to elderly patients with major depressive disorder.
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Int Clin Psychopharmacol · Jan 2013
Meta AnalysisAntidepressant efficacy of agomelatine versus SSRI/SNRI: results from a pooled analysis of head-to-head studies without a placebo control.
Pooled analysis of individual patient data was used to compare the antidepressant efficacy of agomelatine with that of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). We sought head-to-head, double-blind, randomized studies without a placebo arm using antidepressant doses in the licensed range and primary evaluation on the Hamilton scale (HAM-D(17)). Six studies were identified versus venlafaxine, sertraline, fluoxetine, paroxetine or escitalopram. ⋯ Similar results were found in patients with severe depression. Agomelatine was associated with better tolerability than SSRI/SNRI. Agomelatine has favourable efficacy and tolerability versus a range of SSRIs and SNRIs - including agents considered to have superior efficacy - and may deserve benefit-risk analysis as a first-line treatment of major depressive disorder.