To compare 2 methods of switching selective serotonin reuptake inhibitor (SSRI) non-responders or partial responders to duloxetine.
Adult outpatients with DSM-IV major depressive disorder, a Hamilton Rating Scale for Depression (HAM-D(17)) total score of >or= 15, and a Clinical Global Impressions-Severity of Illness score of >or= 3 despite at least 6 weeks of SSRI treatment were randomly assigned to either abrupt discontinuation of SSRI immediately followed by initiation of duloxetine (direct switch [DS]; N = 183) or tapered discontinuation of SSRI over 2 weeks and simultaneous administration of duloxetine (start-taper switch [STS]; N = 185). Efficacy, safety, and tolerability outcomes associated with these 2 switch methods were compared following switch and after 10 weeks of duloxetine treatment. The study was conducted from August 2004 to March 2006.
There was a significant improvement in depressive symptom severity in both switch groups as measured by mean change in HAM-D(17) total score (p <or= .001), but no difference between the switch groups (-10.23 DS vs. -10.49 STS). Criteria for noninferiority of the DS group to the STS group, which was the primary objective of the study, were met. Response rates (54.4% DS vs. 59.6% STS), remission rates (35.7% DS vs. 37.2% STS), and other secondary outcome measures were similar for both switch groups. Few patients discontinued the study due to adverse events (6.6% DS vs. 3.8% STS). Headache, dry mouth, and nausea were the most frequently reported adverse events in both switch groups.
Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used.
clinicaltrials.gov Identifier: NCT00191932.
"Considering as few as one-third of patients treated with SSRIs achieve full remission from their symptoms [Trivedi et al. 2006] there is a clinical need for alternative antidepressants. Switching to another antidepressant class after SSRI treatment failure may be a more effective strategy than within class switching [Papakostas et al. 2008]and data specifically support the safety and efficacy of switching SSRI treatment failures to SNRIs, such as duloxetine [Perahia et al. 2008, 2009; Romera et al. 2012]. Based on this review of the safety data from the SNRIs duloxetine and venlafaxine and the evidence of their efficacy in depression and GAD [Allgulander et al. 2008; Smith et al. 2002; Thase et al. 2007], both drugs appear to have a positive benefit risk profile. "
[Show abstract][Hide abstract] ABSTRACT: Depression and anxiety disorders are among the most common disorders treated by general practitioners (GPs) in the UK. Since both disorders are associated with a significantly increased risk of suicide, including with antidepressant overdose, the safety of antidepressants in overdose is of paramount importance. Numerous updates relating to antidepressant safety have been issued by regulators in the UK which may have eroded GP confidence in antidepressants. Venlafaxine, a serotonin nor adrenaline reuptake inhibitor (SNRI) had primary care prescribing restrictions placed on it in 2004 due to concerns about cardiotoxicity and mortality in overdose. Although a review of the evidence led to a reversal of the majority of restrictions in 2006, evidence suggests GPs may still be cautious in their prescribing of venlafaxine and possibly other SNRI antidepressants for patients with depression and anxiety disorders. This paper reviews the evidence pertaining to the safety of SNRI antidepressants from a perspective of cardiovascular safety and overdose. The currently available evidence suggests a marginally higher toxicity of venlafaxine in overdose compared with another SNRI duloxetine and the selective serotonin reuptake inhibitors (SSRIs), although this may be related to differential patterns of prescribing in high-risk patients. Based on this review SNRIs have a positive risk benefit profile in the treatment of depression and generalized anxiety disorder in primary care, especially as second-line agents to SSRIs.
"int in depression rating scales ( HAMD - 17 and CGI - S ) also did not differ significantly between duloxetine ( 60 mg ) and placebo treatment groups . A summary of pooled data from 3 clinical trials , however , found that , compared with placebo , duloxetine was associated with significant reduction in pain severity ( Goldstein et al . , 2004 ) . Perahia et al . ( 2008b ) found that pa - tients who did not respond to initial treatment with an SSRI and were switched to duloxetine ( 60 mg / day ) saw significant im - provement in VAS overall pain scores ."
"The inhibition of both serotonin and noradrenalin reuptake is a characteristic shared by venlafaxine and the antiobesity drug sibutramine. Duloxetine is another SNRI, recently approved for the treatment of major depressive disorder (Gupta et al., 2007), that leads to improvements in both emotional and painful symptoms of depression (Perahia et al., 2008). It also seems to be helpful in the treatment of generalized anxiety disorder (GAD) (Davidson et al., 2008) and obsessive compulsive disorder (OCD) (Dell'osso et al., 2008). "
[Show abstract][Hide abstract] ABSTRACT: Attempts have been made to find appropriate drug regimens to treat binge eating disorder (BED). Several reports have examined the use of selective serotonin reuptake inhibitors (SSRIs) or mood stabilizers; both serotonin and noradrenalin reuptake inhibitors (SNRIs) have been reported to be useful for binge eating, but the available data are limited. We evaluated the efficacy of duloxetine, an SNRI, in 45 obese patients who reported binge eating.
Forty-five patients with BED or binge eating with sub-threshold symptoms (s-BED) with high eating impulsivity, received duloxetine 60-120 mg/day for 12 weeks.
A significant reduction in number of binges/week was observed in BED patients; statistical analyses performed on the whole sample revealed significant reductions in scores on the binge eating scale (BES) and the Beck depression inventory (BDI), weight, body mass index (BMI), clinical global impression, and the bulimia scale of the eating disorder inventory-2. The reduction in BES and BDI scores was not statistically different between BED and s-BED subjects.
Although preliminary, results from this open trial suggest that duloxetine may be a successful option to reduce binge eating and depressive symptoms in both obese BED and s-BED outpatients.
Human Psychopharmacology Clinical and Experimental 08/2009; 24(6):483-8. DOI:10.1002/hup.1040 · 2.19 Impact Factor
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