Effectiveness of Vortioxetine in Patients with Major Depressive Disorder in Real-World Clinical Practice in Italy: Results from the RELIEVE Study

Abstract

Sergio De Filippis,1 Anna Pugliese,2 Michael Cronquist Christensen,3 Gianluca Rosso,4,5 Marco Di Nicola,6,7 Kenneth Simonsen,3 Hongye Ren3 1Department of Neuropsychiatry, Villa Von Siebenthal Neuropsychiatric Clinic, Genzano di Roma, Italy; 2Medical Department, Lundbeck Italy S.p.A, Milan, Italy; 3Medical Affairs, H. Lundbeck A/S, Valby, Denmark; 4Department of Neurosciences ‘Rita Levi Montalcini’, University of Turin, Turin, Italy; 5Psychiatric Unit, San Luigi Gonzaga University Hospital of Orbassano, Turin, Italy; 6Department of Psychiatry, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; 7Department of Neuroscience, Section of Psychiatry, Università Cattolica del Sacro Cuore, Rome, ItalyCorrespondence: Anna Pugliese, Medical Department, Lundbeck Italy S.p.A, Via Joe Colombo 2, 20121 Milan, Italy, Tel [phone], Fax [phone], Email [email protected]: Vortioxetine has demonstrated efficacy in randomized controlled trials and is approved for the treatment of major depressive disorder (MDD); however, data are limited concerning its effectiveness when used in routine clinical care. The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study aimed to assess the effectiveness and tolerability of vortioxetine for the treatment of MDD in routine clinical practice in Canada, France, Italy, and the USA. This paper presents findings for the patient cohort in Italy.Patients and Methods: RELIEVE was a 6-month, international, observational, prospective cohort study in outpatients initiating vortioxetine treatment for MDD in routine care settings at their physician’s discretion (NCT03555136). Patient functioning was assessed using the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity (9-item Patient Health Questionnaire [PHQ-9]), cognitive symptoms (5-item Perceived Deficits Questionnaire-Depression [PDQ-D-5]), and quality of life (EuroQol 5-Dimensions 5-Levels questionnaire [EQ-5D-5L]). Changes from baseline to month 6 were assessed using mixed models for repeated measures, adjusted for relevant confounders.Results: Data are available for 231 patients enrolled in Italy (mean age, 55.5 years; 27% > 65 years). Overall, 69% of patients reported at least one comorbidity, 55% were overweight/obese, and 47% had current anxiety symptoms. Adjusted least-squares mean (standard error) change in SDS score from baseline to week 24 was − 6.6 (0.6) points (P < 0.001). Respective changes in PHQ-9, PDQ-D-5, and EQ-5D-5L scores were − 5.9 (0.5), − 3.6 (0.4), and +0.13 (0.01) points (all P < 0.0001). Adverse events were reported by 29 patients (13%), most commonly nausea (n = 14, 6%). Eleven patients (5%) discontinued treatment due to adverse events.Conclusion: Clinically relevant and sustained improvements in overall functioning, symptoms of depression, cognitive symptoms, and health-related quality of life were observed in patients with MDD treated with vortioxetine over a period of 6 months in routine care in Italy, including a high proportion of elderly patients.Keywords: major depressive disorder, vortioxetine, effectiveness, functioning, real-world evidence

Keywords

• major depressive disorder
• vortioxetine
• effectiveness
• functioning
• real-world evidence