Real-world effectiveness of vortioxetine in outpatients with major depressive disorder: functioning and dose effects.


Journal

BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559

Informations de publication

Date de publication:
12 08 2022
Historique:
received: 16 11 2021
accepted: 29 06 2022
entrez: 12 8 2022
pubmed: 13 8 2022
medline: 17 8 2022
Statut: epublish

Résumé

Functional recovery is an important treatment goal in major depressive disorder (MDD). This study assessed the real-world effectiveness of vortioxetine in patients with MDD, with particular focus on functioning; dose-response was also assessed. This was a non-interventional, prospective, multicenter study conducted in Greece. Adult outpatients with MDD (n = 336) initiating vortioxetine (5-20 mg/day flexible dosing) as treatment for a current major depressive episode were followed for 3 months. Analyses were stratified according to vortioxetine dosage at 3 months: 5-10 mg/day versus 15-20 mg/day. Functioning was assessed using the Sheehan Disability Scale (SDS). Mean ± standard error SDS total score decreased (improved) from 18.7 ± 0.3 at baseline to 12.9 ± 0.3 after 1 month of vortioxetine treatment and 7.8 ± 0.4 after 3 months (p < 0.001 vs. baseline for all comparisons). Functional recovery (SDS score ≤ 6) was achieved in 14.6% of patients after 1 month of treatment and 48.4% of patients after 3 months. Improvement from baseline in SDS total and domain scores at 3 months was more pronounced in patients receiving vortioxetine 15-20 mg/day than in those receiving vortioxetine 5-10 mg/day. The mean ± standard error change in SDS total score from baseline was 9.2 ± 0.8 in the 5-10 mg/day group and 12.1 ± 0.4 in the 15-20 mg/day group (p < 0.001). Limitations of this study include its non-interventional study design and lack of a control group or active comparator. Statistically significant and clinically relevant improvements in functioning were seen in patients with MDD treated with vortioxetine in a real-world setting. Higher doses of vortioxetine were associated with significantly greater improvements in functioning.

Sections du résumé

BACKGROUND
Functional recovery is an important treatment goal in major depressive disorder (MDD). This study assessed the real-world effectiveness of vortioxetine in patients with MDD, with particular focus on functioning; dose-response was also assessed.
METHODS
This was a non-interventional, prospective, multicenter study conducted in Greece. Adult outpatients with MDD (n = 336) initiating vortioxetine (5-20 mg/day flexible dosing) as treatment for a current major depressive episode were followed for 3 months. Analyses were stratified according to vortioxetine dosage at 3 months: 5-10 mg/day versus 15-20 mg/day. Functioning was assessed using the Sheehan Disability Scale (SDS).
RESULTS
Mean ± standard error SDS total score decreased (improved) from 18.7 ± 0.3 at baseline to 12.9 ± 0.3 after 1 month of vortioxetine treatment and 7.8 ± 0.4 after 3 months (p < 0.001 vs. baseline for all comparisons). Functional recovery (SDS score ≤ 6) was achieved in 14.6% of patients after 1 month of treatment and 48.4% of patients after 3 months. Improvement from baseline in SDS total and domain scores at 3 months was more pronounced in patients receiving vortioxetine 15-20 mg/day than in those receiving vortioxetine 5-10 mg/day. The mean ± standard error change in SDS total score from baseline was 9.2 ± 0.8 in the 5-10 mg/day group and 12.1 ± 0.4 in the 15-20 mg/day group (p < 0.001). Limitations of this study include its non-interventional study design and lack of a control group or active comparator.
CONCLUSIONS
Statistically significant and clinically relevant improvements in functioning were seen in patients with MDD treated with vortioxetine in a real-world setting. Higher doses of vortioxetine were associated with significantly greater improvements in functioning.

Identifiants

pubmed: 35962369
doi: 10.1186/s12888-022-04109-5
pii: 10.1186/s12888-022-04109-5
pmc: PMC9373318
doi:

Substances chimiques

Vortioxetine 3O2K1S3WQV

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

548

Informations de copyright

© 2022. The Author(s).

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Auteurs

Eugenia Papalexi (E)

Lundbeck Hellas, 109 Kifisias Avenue & Sina, 15124, Maroussi, Athens, Greece. EUGE@Lundbeck.com.

Andreas Galanopoulos (A)

Lundbeck Hellas, 109 Kifisias Avenue & Sina, 15124, Maroussi, Athens, Greece.

Dimitrios Kontis (D)

4th Psychiatric Department, Psychiatric Hospital of Attica, Athens, Greece.

Maria Markopoulou (M)

Department of Forensic Psychiatry, Psychiatric Hospital of Thessaloniki, Stavroupolis, Thessaloniki, Greece.

Georgia Balta (G)

Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

Evaggelos Karavelas (E)

Ensynaisthisis, Thessaloniki, Greece.

Panagiotis Panagiotidis (P)

Department of Psychiatry, 424 General Military Hospital of Thessaloniki, Thessaloniki, Greece.

Themistoklis Vlachos (T)

Department of Psychiatry, 251 Airforce Military Hospital, Athens, Greece.

Anders Ettrup (A)

H. Lundbeck A/S, Valby, Denmark.

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