A study of the effects of LY2216684, a selective norepinephrine reuptake inhibitor, in the treatment of major depression

Dubé, Sanjay; Dellva, Mary Anne; Jones, Marcia Thornton; Kielbasa, William; Padich, Robert; Saha, Anupam; Rao, Prasad G

doi:10.1016/j.jpsychires.2009.09.013

Cited by 30 publications

(19 citation statements)

References 5 publications

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“…The most common TEAEs reported during long-term treatment with edivoxetine were consistent with those reported in the acute phase of this study [5] and an earlier edivoxetine study [13], as well as other long-term MDD studies of antidepressants with norepinephrine re-uptake inhibition [14]- [22]. The frequency of SAE occurrence was low (<3%), and there were no deaths during this extension phase.…”

Section: Discussionsupporting

confidence: 86%

“…Although approximately 72% of patients reported TEAEs, most events were considered mild or moderate in severity. In general, the TEAEs reported by the PBO/EDX group occurred with numerically greater fre- quency than what was observed in the EDX/EDX group, but they were similar to the rates reported by edivoxetine-treated patients in the acute placebo-controlled phase of the study, as well as in another earlier study of edivoxetine in MDD [13]. The higher incidence of TEAEs in the PBO/EDX group during the extension phase may reflect the lack of prior exposure to edivoxetine; whereas, the lower incidence of TEAEs in the EDX/EDX group suggests that most TEAEs occur early in treatment and become less frequent over time.…”

Section: Discussionsupporting

confidence: 77%

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Safety and Tolerability of Edivoxetine for Long-Term Treatment of Major Depressive Disorder in Adult Patients

Oakes

Martinez²,

Dellva³

et al. 2014

OJPsych

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This 12-month open-label, but dose-blinded extension phase, evaluated the safety and tolerability of flexibly-dosed edivoxetine (6, 9, 12 or 18 mg once daily) in patients (N = 397) with major depressive disorder, who completed the 10-week randomized, double-blind, placebo-controlled acute phase of the study. All patients were treated with edivoxetine during the extension phase. The mean age of the patients was 45 years, and most were white females. Safety evaluations included assessment of treatment-emergent adverse events (TEAEs), laboratory and vital sign measures, and suicidality. Within-group t-tests based on a 2-sided significance level of 0.05 and 95% confidence levels were used to assess whether changes from baseline were statistically significant from zero. The overall completion rate was 54%. Adverse event was the most common (14.4%) reason for discontinuation, which included blood pressure increased (1.3%), heart rate increased (1.3%), anxiety (1.0%), and tachycardia (1.0%). At least 1 TEAE was reported by 72.3% of patients, of which headache (10.8%) and hyperhidrosis (10.1%) were the most common; 2.8% of patients had ≥1 serious adverse events, and there were no completed suicides. No clinically relevant changes were observed in most laboratory measures. Potentially clinically significant changes in ALT values occurred in 1.8% of patients, and either normalized or had decreased by the last assessment. Mean increases in blood pressure and pulse were consistent with those observed in the acute phase and appeared to reach a plateau within 3 to 5 months of treatment. In conclusion, safety and tolerability findings during this long-term extension phase evaluation of edivoxetine were consistent with its norepinephrine reuptake inhibition profile.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 77%

Safety and Tolerability of Edivoxetine for Long-Term Treatment of Major Depressive Disorder in Adult Patients

Oakes

Martinez²,

Dellva³

et al. 2014

OJPsych

Self Cite

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show abstract

“…Three double-blind studies have been conducted with edivoxetine in adult patients with MDD (Ball et al 2010;Dubé et al 2010;Pangallo et al 2011). Based on the data from healthy adults, edivoxetine appears to be less dependent on the cytochrome P450 (CYP) 2D6 enzyme for metabolism than atomoxetine, and may have less exposure variability in patients with diverse CYP2D6 polymorphisms (Kielbasa et al 2011).…”

mentioning

confidence: 99%

Clinical Outcomes from an Open-Label Study of Edivoxetine Use in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder

Jin

Krefetz³

et al. 2013

Journal of Child and Adolescent Psychopharmacology

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“…In two clinical trials, the efficacy of edivoxetine monotherapy [17,18] was uncertain when compared to that of placebo for treatment of MDD; the drug also presented safety and tolerability issues such as significant increases in pulse rate and systolic and diastolic blood pressure and a significantly higher rate of discontinuation due to AEs or death. In addition, a recent combination trial of edivoxetine with SSRIs [19] also failed to show superiority to placebo combined with SSRIs.…”

Section: Introductionmentioning

confidence: 99%

Criticisms of drugs in early development for the treatment of depression: what can be improved?

Wang

Han

Pae

2014

Expert Opinion on Investigational Drugs

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A study of the effects of LY2216684, a selective norepinephrine reuptake inhibitor, in the treatment of major depression

Cited by 30 publications

References 5 publications

Safety and Tolerability of Edivoxetine for Long-Term Treatment of Major Depressive Disorder in Adult Patients

Safety and Tolerability of Edivoxetine for Long-Term Treatment of Major Depressive Disorder in Adult Patients

Clinical Outcomes from an Open-Label Study of Edivoxetine Use in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder

Criticisms of drugs in early development for the treatment of depression: what can be improved?

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