| Autor: |
James M Martinez, Margaret B Ferguson, Beth A Pangallo, Tina M Oakes, JonDavid Sparks, Mary Anne Dellva, Qi Zhang, Peng Liu, Mark Bangs, Jonna Ahl, Celine Goldberger |
| Jazyk: |
angličtina |
| Rok vydání: |
2015 |
| Předmět: |
|
| Zdroj: |
Drugs in Context, Pp 1-10 (2015) |
| Druh dokumentu: |
article |
| ISSN: |
1740-4398 |
| DOI: |
10.7573/dic.212279 |
| Popis: |
Objective: The aim of this analysis was to assess the safety profile of edivoxetine as adjunctive treatment to selective serotonin reuptake inhibitor (SSRI) antidepressants. Methods: A pooled analysis was conducted on data obtained from the integrated safety database of edivoxetine as adjunctive treatment to SSRIs. Safety and tolerability assessments included discontinuation rates, spontaneously reported treatment-emergent adverse events (TEAEs), clinical laboratory tests, blood pressure (BP) and pulse, and electrocardiograms (ECGs). Results: The analysis included 1260 patients treated with adjunctive edivoxetine and 806 treated with adjunctive placebo. Study completion rates were 85.2% and 84.5% (p=0.994), respectively. Discontinuations due to adverse events were 4.9% and 3.5% (p=0.07), respectively. Significantly more patients in the adjunctive edivoxetine group compared with adjunctive placebo group reported at least one TEAE (56.8 vs 43.7%, p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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