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

Abstract

Purpose

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

Data Sharing Statement

The data supporting the findings of this study are available within the manuscript. The corresponding author may be contacted for further data sharing.

Acknowledgments

Thanks to the following principal investigators at the participating Italian study sites: Eugenio Aguglia, Silvio Bellino, Antonello Bellomo, Giuseppe Bersani, Massimo Biondi, Roberto Brugnoli (co-investigator), Domenico Buccomino, Gaetano Callista, Massimo Clerici, Bernardo Dell’Osso, Giovanni Dominici, Pasquale De Fazio, Sergio De Filippis, Serafino De Giorgi, Marco Di Nicola, Orsola Gambini, Giuseppe Maina, Giuseppe Nicolò, Stefano Pallanti, Giampaolo Perna, Maurizio Pompili, Gianluca Rosso, Gabriele Sani, Fabrizio Stocchi, Alfonso Tortorella, Caterina Viganò, and Antonio Vita. Medical writing assistance was provided by Jennifer Coward of Piper Medical Communications, funded by H. Lundbeck A/S.

Author Contributions

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agreed to be accountable for all aspects of the work.

Disclosure

SDF has been a consultant and/or speaker for the following organizations: Angelini Pharma, ArcaPharma, DI.RA.LAB, Ecupharma, Janssen, Lundbeck, Mylan, Molteni, Neuraxpharma, and Otsuka. AP is an employee of Lundbeck Italy S.p.A. MCC is an employee of H. Lundbeck A/S. GR reports grants from Lundbeck during the conduct of the study; grants and personal fees from Janssen Cilag; and personal fees from Lundbeck, Angelini Pharma, Otsuka, Viatris, and GlaxoSmithKline, outside the submitted work. MDN has been a speaker for Angelini, Janssen, Lundbeck, Neuraxpharma, and Otsuka. KS and HR were employees of H. Lundbeck A/S at the time this study was conducted.

Additional information

Funding

The RELIEVE study was funded by H. Lundbeck A/S, whose personnel contributed to the data analysis, review of the data, and review of this manuscript.