P.0724 Vortioxetine in routine clinical practice: results from the real-life effectiveness of vortioxetine (RELIEVE) study

Effectiveness and Safety of Vortioxetine for Major Depressive Disorder in Real-World Clinical Practice: Results from the Single-Arm RELIEVE China Study

“…The functional and cognitive improvements observed in the RELIEVE China study are consistent with observations of the efficacy of vortioxetine in RCTs, 15,[22][23][24][25][26]31 as well as with a similar study observing real-world patients with MDD in North America and Europe after they initiated treatment with vortioxetine. 32 For example, vortioxetine 10 mg was associated with a 7.59-point reduction in total SDS score after 8 weeks when starting from a baseline of 18.9 points in an earlier randomized controlled trial in Asia compared with a 5.42-point reduction from a baseline of 16.7 points in the current study. 31 In addition, the 8.44-point reduction in PDQ score observed among patients treated with vortioxetine in the RELIEVE China study at week 8 (baseline, 36.5 points) is also similar to the 12.2-to 13.5-point reduction reported in an earlier meta-analysis of patients with MDD administered vortioxetine 10-20 mg in clinical trials (baseline, 41.1-41.4 points).…”

“…Vortioxetine was well tolerated, and the safety profile in this real-world study population of Chinese patients with MDD was consistent with the known profile of observations from clinical trials and other real-world studies of vortioxetine. 31 , 32 , 34 Nausea was the most common treatment-related AE, but this has previously been reported as generally occurring within the first few weeks of initiating treatment and tends to be transient in nature. 34 …”

“…19,20,33 Vortioxetine was well tolerated, and the safety profile in this real-world study population of Chinese patients with MDD was consistent with the known profile of observations from clinical trials and other real-world studies of vortioxetine. 31,32,34 Nausea was the most common treatment-related AE, but this has previously been reported as generally occurring within the first few weeks of initiating treatment and tends to be transient in nature. 34 The relatively high proportion of patients (>20%) prescribed an overdose of vortioxetine in this study, which accounted for approximately one-third of treatment-related AEs, can be explained by marketing authorization for a 20-mg dose of vortioxetine approved by the Chinese National Medical Products Administration in August 2020, when the study was already underway.…”