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Open access

Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness

Narcis Cardoner 1, 2, 3, 4
Luis Gutiérrez-Rojas 5, 6
Pilar Saiz 7, 8, 9, 10, 11
Guillermo Lahera 8, 12, 13, 14
Miguel Ángel Álvarez-Mon 8, 15, 16, 17
Pino Alonso Ortega 8, 18, 19, 20
María Pérez-Páramo 21
2
 
Institut d’Investigació Biomèdica Sant Pau IIB SANT PAU, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
10
 
Instituto Universitario de Neurociencias del Principado de Asturias (INEUROPA), Oviedo, Spain
11
 
Servicio de Salud del Principado de Asturias (SESPA) Oviedo, Oviedo, Spain
13
 
Príncipe de Asturias University Hospital, Oviedo, Spain
18
 
Department of Psychiatry, Hospital de Bellvitge, Barcelona, Spain
21
 
Medical Department, Viatris, Madrid, Spain
Publication typeJournal Article
Publication date2025-02-07
scimago Q1
wos Q1
SJR1.220
CiteScore8.9
Impact factor4.8
ISSN16639812
Abstract
Introduction

Generalized Anxiety Disorder (GAD) is a mental health condition with a recent increase in prevalence. GAD is often underdiagnosed, leading to negative consequences for individuals, healthcare systems, and society. The economic burden and impaired quality of life associated with GAD underscores the need for effective treatment. Pregabalin has shown promise in reducing anxiety symptoms; however, further research is needed to evaluate its efficacy and compare it with other treatment options. This study aimed to assess the efficacy, safety, and optimal pregabalin dosage for the treatment of GAD.

Methods

This meta-analysis followed PRISMA guidelines. Pregabalin-treated patients comprised the intervention group, whereas the comparator group received benzodiazepines, SSRIs, SNRIs, or placebo. Efficacy and safety were evaluated using various scales and adverse events (AEs). Randomized clinical trials were included in the study. Four major databases were used for this study. Outcome measures included the Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Improvement Scale (CGI-I), discontinuation rates, costs, and quality-adjusted life-years (QALYs). Meta-analyses were conducted using Review Manager 5.4 software, employing odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs). Subgroup and sensitivity analyses were performed based on follow-up and dosage.

Results

Fourteen studies involving 4,822 patients were analyzed. Pregabalin demonstrated superior efficacy in reducing HAM-A global scores at 2 weeks (MD −1.23, 95% CI −1.79 to −0.66), 4 weeks (MD −1.12, 95% CI −1.60 to −0.63), 8 weeks (MD −2.50, 95% CI −4.21 to −0.79), 12 weeks (MD 0.99, 95% CI 0.35–1.63), and 6 months to 1 year (MD −3.31, 95% CI −4.30 to −2.31). Pregabalin also showed a higher response rate to HAM-A (OR 1.51, 95% CI 1.31 1.75). CGI-I scores favored pregabalin (MD −0.25, 95% CI −0.38 to −0.12), with a higher response rate (OR 1.33, 95% CI 1.15–1.55). The discontinuation rates were lower with pregabalin (OR 0.80, 95% CI 0.70, 0.91). Adverse events favored pregabalin over SSRIs/SNRIs and benzodiazepines at different doses. Pregabalin was associated with higher cost-effectiveness (MD 0.02, 95% CI 0.01, 0.03).

Conclusion

Pregabalin is an effective and well-tolerated treatment for generalized anxiety disorder, showing superior efficacy and safety compared with first-line medications.

Systematic Review Registration

PROSPERO CRD42024556152.

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Cardoner N. et al. Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness // Frontiers in Pharmacology. 2025. Vol. 16.
GOST all authors (up to 50) Copy
Cardoner N., Gutiérrez-Rojas L., Saiz P., Lahera G., Álvarez-Mon M. Á., Alonso Ortega P., Pérez-Páramo M. Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness // Frontiers in Pharmacology. 2025. Vol. 16.
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RIS Copy
TY - JOUR
DO - 10.3389/fphar.2025.1483770
UR - https://www.frontiersin.org/articles/10.3389/fphar.2025.1483770/full
TI - Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness
T2 - Frontiers in Pharmacology
AU - Cardoner, Narcis
AU - Gutiérrez-Rojas, Luis
AU - Saiz, Pilar
AU - Lahera, Guillermo
AU - Álvarez-Mon, Miguel Ángel
AU - Alonso Ortega, Pino
AU - Pérez-Páramo, María
PY - 2025
DA - 2025/02/07
PB - Frontiers Media S.A.
VL - 16
SN - 1663-9812
ER -
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BibTex (up to 50 authors) Copy
@article{2025_Cardoner,
author = {Narcis Cardoner and Luis Gutiérrez-Rojas and Pilar Saiz and Guillermo Lahera and Miguel Ángel Álvarez-Mon and Pino Alonso Ortega and María Pérez-Páramo},
title = {Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness},
journal = {Frontiers in Pharmacology},
year = {2025},
volume = {16},
publisher = {Frontiers Media S.A.},
month = {feb},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2025.1483770/full},
doi = {10.3389/fphar.2025.1483770}
}