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Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study

OBJECTIVES: The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure(®)) versus branded escitalopram (Lexapro(®)) for patients with major depressive disorder (MDD). METHODS: The present study included 158 patients, who w...

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Autores principales: Jeong, Jong-Hyun, Bahk, Won-Myong, Woo, Young Sup, Lee, Kyung-Uk, Kim, Do Hoon, Kim, Moon-Doo, Kim, Won, Yang, Jong-Chul, Lee, Kwang Heun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4605251/
https://www.ncbi.nlm.nih.gov/pubmed/26504387
http://dx.doi.org/10.2147/NDT.S90796
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author Jeong, Jong-Hyun
Bahk, Won-Myong
Woo, Young Sup
Lee, Kyung-Uk
Kim, Do Hoon
Kim, Moon-Doo
Kim, Won
Yang, Jong-Chul
Lee, Kwang Heun
author_facet Jeong, Jong-Hyun
Bahk, Won-Myong
Woo, Young Sup
Lee, Kyung-Uk
Kim, Do Hoon
Kim, Moon-Doo
Kim, Won
Yang, Jong-Chul
Lee, Kwang Heun
author_sort Jeong, Jong-Hyun
collection PubMed
description OBJECTIVES: The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure(®)) versus branded escitalopram (Lexapro(®)) for patients with major depressive disorder (MDD). METHODS: The present study included 158 patients, who were randomized (1:1) to receive a flexible dose of generic escitalopram (n=78) or branded escitalopram (n=80) over a 6-week single-blind treatment period. The clinical benefits in the two groups were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impressions-Severity scale (CGI-S), and the Clinical Global Impressions-Improvement scale (CGI-I) at baseline, week 1, week 2, week 4, and week 6. The frequency of adverse events (AEs) was also assessed to determine safety at each follow-up visit. RESULTS: During the 6-week study period, 30 patients (38.5%) from the generic escitalopram group and 28 patients (30.0%) from the branded escitalopram group dropped out of the study (P=0.727). The MADRS, HDRS, CGI-S, and CGI-I scores significantly decreased in both groups, and there were no significant differences between the groups. At week 6, 28 patients (57.1%) in the generic escitalopram group and 35 patients (67.3%) in the branded escitalopram group had responded to treatment (as indicated by a ≥50% decrease from the baseline MADRS score; P=0.126), and the remission rates (MADRS score: ≤10) were 42.9% (n=21) in generic escitalopram group and 53.8% (n=28) in the branded escitalopram group (P=0.135). The most frequently reported AEs were nausea (17.9%), sleepiness/somnolence (7.7%), weight gain (3.8%), and dry mouth (2.6%) in the generic escitalopram group and nausea (20.0%), sleepiness/somnolence (3.8%), weight gain (2.5%), and dry mouth (2.5%) in the branded escitalopram group. CONCLUSION: The present non-inferiority study demonstrated that generic escitalopram is a safe and an effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population.
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spelling pubmed-46052512015-10-26 Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study Jeong, Jong-Hyun Bahk, Won-Myong Woo, Young Sup Lee, Kyung-Uk Kim, Do Hoon Kim, Moon-Doo Kim, Won Yang, Jong-Chul Lee, Kwang Heun Neuropsychiatr Dis Treat Original Research OBJECTIVES: The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure(®)) versus branded escitalopram (Lexapro(®)) for patients with major depressive disorder (MDD). METHODS: The present study included 158 patients, who were randomized (1:1) to receive a flexible dose of generic escitalopram (n=78) or branded escitalopram (n=80) over a 6-week single-blind treatment period. The clinical benefits in the two groups were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impressions-Severity scale (CGI-S), and the Clinical Global Impressions-Improvement scale (CGI-I) at baseline, week 1, week 2, week 4, and week 6. The frequency of adverse events (AEs) was also assessed to determine safety at each follow-up visit. RESULTS: During the 6-week study period, 30 patients (38.5%) from the generic escitalopram group and 28 patients (30.0%) from the branded escitalopram group dropped out of the study (P=0.727). The MADRS, HDRS, CGI-S, and CGI-I scores significantly decreased in both groups, and there were no significant differences between the groups. At week 6, 28 patients (57.1%) in the generic escitalopram group and 35 patients (67.3%) in the branded escitalopram group had responded to treatment (as indicated by a ≥50% decrease from the baseline MADRS score; P=0.126), and the remission rates (MADRS score: ≤10) were 42.9% (n=21) in generic escitalopram group and 53.8% (n=28) in the branded escitalopram group (P=0.135). The most frequently reported AEs were nausea (17.9%), sleepiness/somnolence (7.7%), weight gain (3.8%), and dry mouth (2.6%) in the generic escitalopram group and nausea (20.0%), sleepiness/somnolence (3.8%), weight gain (2.5%), and dry mouth (2.5%) in the branded escitalopram group. CONCLUSION: The present non-inferiority study demonstrated that generic escitalopram is a safe and an effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population. Dove Medical Press 2015-10-09 /pmc/articles/PMC4605251/ /pubmed/26504387 http://dx.doi.org/10.2147/NDT.S90796 Text en © 2015 Jeong et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Jeong, Jong-Hyun
Bahk, Won-Myong
Woo, Young Sup
Lee, Kyung-Uk
Kim, Do Hoon
Kim, Moon-Doo
Kim, Won
Yang, Jong-Chul
Lee, Kwang Heun
Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title_full Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title_fullStr Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title_full_unstemmed Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title_short Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
title_sort efficacy and safety of generic escitalopram (lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4605251/
https://www.ncbi.nlm.nih.gov/pubmed/26504387
http://dx.doi.org/10.2147/NDT.S90796
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