Cargando…

Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors

BACKGROUND: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor...

Descripción completa

Detalles Bibliográficos
Autores principales: Álvarez, Enrique, Olivares, José M, Carrasco, José L, López-Gómez, Vanessa, Rejas, Javier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4308936/
https://www.ncbi.nlm.nih.gov/pubmed/25632294
http://dx.doi.org/10.1186/s12991-014-0040-0
_version_ 1782354613728444416
author Álvarez, Enrique
Olivares, José M
Carrasco, José L
López-Gómez, Vanessa
Rejas, Javier
author_facet Álvarez, Enrique
Olivares, José M
Carrasco, José L
López-Gómez, Vanessa
Rejas, Javier
author_sort Álvarez, Enrique
collection PubMed
description BACKGROUND: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor (SSRI) course in medical practice in Spain. METHODS: Post hoc analysis of patients with PR to SSRI monotherapy enrolled in a prospective 6-month naturalistic study was done. PR was defined as a Clinical Global Impression (CGI) scale score ≥3 and insufficient response with persistence of anxiety symptoms ≥16 in the Hamilton Anxiety Rating Scale (HAM-A). Two groups were analyzed: 1) adjunctive therapy (AT) with pregabalin (150–600 mg/day) to existing therapy and 2) UC (switching to a different SSRI or adding another anxiolytic different than pregabalin). Costs included GAD-related health-care resources utilization. Consequences were a combination of psychiatrist-based measurements [HAM-A, CGI, and Montgomery-Asberg Depression Rating Scale (MADRS)] and patient-reported outcomes [Medical Outcomes Study Sleep (MOS-sleep) scale, disability (World Health Organization Disability Assessment Schedule II (WHO-DAS II) and quality-of-life (Euro Qol-5D (EQ-5D)]. Changes in both health-care costs and scale scores were compared separately at end-of-trial visit by a general linear model with covariates. RESULTS: Four hundred eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs. UC in HAM-A [−14.9 (−15.6; −14.2) vs. −11.2 (−12.2; −10.2), p < 0.001] and MADRS [−11.6 (−12.2; −10.9) vs. −7.8 (−8.7; −6.8), p < 0.001]. Changes in all patient-reported outcomes favored significantly patients receiving pregabalin, including quality-of-life gain; 26.4 (24.7; 28.1) vs. 19.4 (17.1; 21.6) in the EQ-VAS, p < 0.001. Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777. The effect of sex on costs and consequences were negligible. CONCLUSION: In medical practice, GAD patients with PR to SSRI experienced greater consequence improvements with adjunctive therapy with pregabalin versus UC, without increasing health-care cost. The effect of pregabalin was independent of patient gender.
format Online
Article
Text
id pubmed-4308936
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-43089362015-01-29 Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors Álvarez, Enrique Olivares, José M Carrasco, José L López-Gómez, Vanessa Rejas, Javier Ann Gen Psychiatry Review BACKGROUND: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor (SSRI) course in medical practice in Spain. METHODS: Post hoc analysis of patients with PR to SSRI monotherapy enrolled in a prospective 6-month naturalistic study was done. PR was defined as a Clinical Global Impression (CGI) scale score ≥3 and insufficient response with persistence of anxiety symptoms ≥16 in the Hamilton Anxiety Rating Scale (HAM-A). Two groups were analyzed: 1) adjunctive therapy (AT) with pregabalin (150–600 mg/day) to existing therapy and 2) UC (switching to a different SSRI or adding another anxiolytic different than pregabalin). Costs included GAD-related health-care resources utilization. Consequences were a combination of psychiatrist-based measurements [HAM-A, CGI, and Montgomery-Asberg Depression Rating Scale (MADRS)] and patient-reported outcomes [Medical Outcomes Study Sleep (MOS-sleep) scale, disability (World Health Organization Disability Assessment Schedule II (WHO-DAS II) and quality-of-life (Euro Qol-5D (EQ-5D)]. Changes in both health-care costs and scale scores were compared separately at end-of-trial visit by a general linear model with covariates. RESULTS: Four hundred eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs. UC in HAM-A [−14.9 (−15.6; −14.2) vs. −11.2 (−12.2; −10.2), p < 0.001] and MADRS [−11.6 (−12.2; −10.9) vs. −7.8 (−8.7; −6.8), p < 0.001]. Changes in all patient-reported outcomes favored significantly patients receiving pregabalin, including quality-of-life gain; 26.4 (24.7; 28.1) vs. 19.4 (17.1; 21.6) in the EQ-VAS, p < 0.001. Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777. The effect of sex on costs and consequences were negligible. CONCLUSION: In medical practice, GAD patients with PR to SSRI experienced greater consequence improvements with adjunctive therapy with pregabalin versus UC, without increasing health-care cost. The effect of pregabalin was independent of patient gender. BioMed Central 2015-01-22 /pmc/articles/PMC4308936/ /pubmed/25632294 http://dx.doi.org/10.1186/s12991-014-0040-0 Text en © Álvarez et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Álvarez, Enrique
Olivares, José M
Carrasco, José L
López-Gómez, Vanessa
Rejas, Javier
Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title_full Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title_fullStr Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title_full_unstemmed Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title_short Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
title_sort clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4308936/
https://www.ncbi.nlm.nih.gov/pubmed/25632294
http://dx.doi.org/10.1186/s12991-014-0040-0
work_keys_str_mv AT alvarezenrique clinicalandeconomicoutcomesofadjunctivetherapywithpregabalinorusualcareingeneralizedanxietydisorderpatientswithpartialresponsetoselectiveserotoninreuptakeinhibitors
AT olivaresjosem clinicalandeconomicoutcomesofadjunctivetherapywithpregabalinorusualcareingeneralizedanxietydisorderpatientswithpartialresponsetoselectiveserotoninreuptakeinhibitors
AT carrascojosel clinicalandeconomicoutcomesofadjunctivetherapywithpregabalinorusualcareingeneralizedanxietydisorderpatientswithpartialresponsetoselectiveserotoninreuptakeinhibitors
AT lopezgomezvanessa clinicalandeconomicoutcomesofadjunctivetherapywithpregabalinorusualcareingeneralizedanxietydisorderpatientswithpartialresponsetoselectiveserotoninreuptakeinhibitors
AT rejasjavier clinicalandeconomicoutcomesofadjunctivetherapywithpregabalinorusualcareingeneralizedanxietydisorderpatientswithpartialresponsetoselectiveserotoninreuptakeinhibitors