Vortioxetine in treatment of depression with somatic comorbidities in routine practice: sub-group analysis of the...

Presence of comorbidities can complicate the diagnosis and treatment of major depressive disorder (MDD), and often requires tailored therapeutic strategies. Primary effectiveness findings from the RELIEVE study demonstrated the effectiveness of vortioxetine treatment in improving patient function, cognitive performance, and health-related quality of life. The aim of the current sub-group analyses was to evaluate the effectiveness of vortioxetine in patients with MDD plus somatic comorbidities recorded at baseline.

RELIEVE was a 24-week observational study (NCT03555136) of outpatients with MDD starting vortioxetine in routine care. We evaluated effectiveness using patient reported outcomes in those sub-groups of patients with somatic comorbid conditions that had sufficient representation in the RELIEVE database (n ≥ 50).

Of the 737 patients with MDD in the RELIEVE study, 428 (58.1 %) had a somatic co-morbidity and/or obesity reported in their medical records at baseline. The most common somatic conditions recorded were obesity 186 (25.2 %; defined as BMI ≥30), sleep disorders 162 (22.0 %), cardiovascular disorders 123 (16.7 %), chronic pain 63 (8.5 %), and diabetes 53 (7.2 %). Sustained clinically meaningful improvements in patient functioning as assessed by Sheehan disability scores (primary effectiveness endpoint; change from baseline to week 24 ranging from -7.1 to -9.7 points across sub-groups) were consistently observed in all comorbidity sub-groups.

The RELIEVE study was not primarily designed to investigate effectiveness of vortioxetine in patients with somatic comorbidities.

Improvements in functioning and symptoms were observed over the 24-week period among patients with MDD and comorbid obesity, sleep disorders, cardiovascular disease, chronic pain, or diabetes, receiving vortioxetine treatment in routine practice.